An RCT to Evaluate the Effect of a New Skin Care Regimen on SBF in Those With Podoconiosis

• Sponsor: University of Hull (Other)
• Overall Status: Completed
• CT.gov ID: NCT02839772
• Collaborator: Procter and Gamble (Industry)
• Enrollment: 193
• Arms: 2
• Duration (Months): 7

Study Details

Study Description

Brief Summary

An RCT (n=193) in two podoconiosis clinics in Ethiopia to evaluate the effectiveness of a research based skin management regimen compared to the current regimen. The experimental group added 2% glycerine to the current skin care regimen and used 1 litre of water in the water soak compared to the 6 litres used in the current regimen.

Condition or Disease	Intervention/Treatment	Phase
Non-filarial Elephantiasis	Other: Current skin care regimen plus 2% glycerine added to soaking water; Other: Current skin care regimen	Phase 3

Detailed Description

Background. Podoconiosis (non-filarial elephantiasis) affects some of the poorest people in 20 countries in the world. In Ethiopia least 3 million people are affected with 17 million at risk. Irritant minerals (smectite, mica and quartz) from volcanic soil and pathogens enter skin breaches in the feet causing inflammation, lymphoedema and hyperkeratosis. Podoconiosis is preventable and treatable but is not curable. Current treatment consists of educating those with disease on its causes, prevention and treatment. Treatment taught in the Action on Podoconiosis (APA) Clinics consists of a daily hygiene regimen of washing the feet/legs with soap, soaking the feet and legs in water with sodium hypochlorite (NaOCI) (0.0125%) added as a disinfectant, air drying and the application of a thin layer of petrolatum jelly. Whitfields ointment (benzoic acid and salicylic acid) is applied to any fungal infections. Wearing shoes is encouraged but this does not offer complete protection against the alkaline soil.

Although the current treatment skin care regimen is effective there is no robust evidence on optimal skin care regimens to improve skin barrier function in this disease.

Objective. To evaluate the effectiveness of a new, low-cost, evidence-based skin care intervention to improve SBF in the lower limbs of those with podoconiosis.

Method. A randomized control trial (RCT) was conducted over 3 months in two APA Clinics (n=193). Intervention was 2% glycerine (v/v) added to a reduced amount of soaking water (1 litre versus 6 litres). The control group received the current skin care regimen. The primary outcome measure was skin barrier function (SBF). This was determined by measures of trans-epidermal water loss (TEWL) and stratum corneum hydration (SCH) at four specific sites on the lower limbs.

Study Design

• Study Type: Interventional
• Actual Enrollment: 193 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomised Controlled Trial to Evaluate the Effect of a New Skin Care Regimen on Skin Barrier Function in Those With Podoconiosis in Ethiopia
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Current skin care regimen Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (0.0125%), air dried, thin layer of petrolatum jelly applied and Whitfields ointment if required for any fungal infection.	Other: Current skin care regimen
Experimental: Current skin regimen plus 2% glycerine Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied and Whitfields ointment if required for any fungal infection.	Other: Current skin care regimen plus 2% glycerine added to soaking water; Other Names: glycerine

Outcome Measures

Primary Outcome Measures

1. Change in TEWL at Top of Outer Lower Legs [Change from baseline following 3 months of intervention]

   Trans-epidermal water loss (TEWL) was measured with a Vapometer (non-invasive probe) on the outer lower leg 8 cms below the head of the fibula. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.

2. Change in TEWL at Mid-point Outer Lower Legs [Change from baseline following 3 months of intervention]

   Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the outer lower leg. This was mid-way between the measurement site at the top of the outer leg and the site at the base of the outer lower leg. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.

3. Change in TEWL at Base of Outer Lower Legs [Change from baseline following 3 months of intervention]

   Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the outer lower leg 8cms above the external malleolus. A reduction in TEWL indicates a positive effect on skin barrier function.It is generally recommended that differences or percentage changes are reported rather than absolute values. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.

4. Change in TEWL at Top of Feet [Change from baseline following 3 months of intervention]

   Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the top of the foot. A reduction in TEWL indicates a positive effect on skin barrier function.It is generally recommended that differences or percentage changes are reported rather than absolute values. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.

5. Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs [Change from baseline following 3 months of intervention]

   Stratum corneum hydration was measured at a specific point at top of outer lower leg (8cms below the head of the fibula) with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.

6. Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg. [Change from baseline following 3 months of intervention]

   SCH was measured mid-way between the measurement site at the top of the outer leg and the site at the base of the outer lower leg. It was measured with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.

7. Change in Stratum Corneum Hydration at Base of Outer Lower Leg [Change from baseline following 3 months of intervention]

   Stratum corneum hydration was measured at the base of the outer lower leg 8 cms above the external malleolus. It was measured with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.

8. Change in Stratum Corneum Hydration at Top of Feet [Change from baseline following 3 months of intervention]

   Stratum corneum hydration measured at a specific point on the middle top of the foot with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.

Secondary Outcome Measures

1. Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit [Change from baseline following 3 months of intervention]

   Podoconiosis Staging System (1-5) used with 5 the most severe stage. This staging system was specifically designed for those with podoconiosis. Legs with stages 1, 2 or 3 were categorised with mild/moderate disease and those with stages 4,5 with severe disease.

2. Total Number of Trophic Skin Changes (Mossy Changes) All Participants at Baseline and 4th Visit [Change from baseline following 3 months of intervention]

   Total number of observed trophic changes (mossy eruptions on the skin of the lower legs/feet characteristic of podoconiosis) in all participants by clinic nurse at baseline and at 4th visit. Trophic changes were either present or not present.

3. Total Number of All Participants With the Presence of a Bad Odour Emanating From Their Lower Limbs. [Change from baseline following 3 months of intervention]

   Change in the presence of bad odour emanating from wounds on participant's lower legs/feet as determined by clinic nurse. Bad odour results in social stigma and impacts of quality of life.

4. Number of Wounds on Lower Legs/Feet of Participants. [Change from baseline following 3 months of intervention]

   Observation and count of number of wounds (all breaches of the stratum corneum including areas of fungal infection) on lower legs/feet by clinic nurse. Breaches in the skin and areas of fungal infection are more likely to occur in those with an impaired skin barrier function.A reduction in the number of wounds indicates an improvement in SBF.

5. Change in Number of Work Days Lost in Previous Month Due to Adenolymphangitis (ADL) [Change from baseline following 3 months of intervention]

   Verbal questioning of participants by clinic nurse or social worker as to number of work days lost due to severe leg pain (adenolymphangitis). Questioning was used as most participants were illiterate.

6. Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds [From baseline monthly for 3 months]

   Statistical calculation of the correlation between the number of work days lost in the previous month due to leg pain (adenolymphangitis) and the number of wounds present on the lower leg/foot. Wounds on the lower legs/feet may produce a bad odour.

7. Change in Largest Lower Leg Circumference [Change from baseline following 3 months of intervention]

   Measured by clinic nurse in centimetres with a disposable tape measure at the point of largest circumference on the foot.

8. Change in Largest Foot Circumference [Change from baseline following 3 months of intervention]

   Measured by clinic nurse in centimetres with a disposable tape measure at the point of largest circumference on the foot

9. Amharic Dermatology Life Quality Index (DLQI) [Change from baseline following 3 months of intervention]

   The Amharic version of the DLQI has been validated for use in Ethiopia where Amharic is the official working language. The index is divided into 4 sections covering leisure, work and school, personal relationships and treatment. The maximum score of 30 indicates a high impact on quality of life. The lowest score zero. A reduction in the number indicates an improvement in quality of life. Participants were verbally questioned by the clinic nurse or social worker as most participants were illiterate.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients in Ethiopia with a diagnosis of podoconiosis. That is those living above 1000 feet sea level with high rainfall, above 1,00mm annually with foot or lower leg oedema which had started in the feet, with sensation present in the feet and no hand involvement. The diagnosis was determined by the nurses at the outreach clinics.

• Patients who were able to understand instructions and give informed consent as determined by the nurses at the outreach clinics.

• Patients over 18 years of age.

Exclusion Criteria:

• Patients not diagnosed with podoconiosis as determined by nurses at the outreach clinics.

• Patients who were unable to understand instructions or give informed consent as determined by nurses at the outreach clinics.

• Patients under 18 years of age.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Hull
• Procter and Gamble

Investigators

• Principal Investigator: Jill Brooks, PhD student, University of Hull, UK
• Study Director: Steven J Ersser, PhD,, University of Leeds, UK
• Study Director: Fiona C Cowdell, DProf,, University of Hull, UK
• Study Director: Eric Gardiner, PhD,, University of Hull, UK
• Study Director: Paul J Matts, PhD, Procter and Gamble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jill Brooks, PhD student, University of Hull
• ClinicalTrials.gov Identifier: NCT02839772
• Other Study ID Numbers: UHull
• First Posted: Jul 21, 2016
• Last Update Posted: Jan 6, 2017
• Last Verified: Aug 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Jill Brooks, PhD student, University of Hull: podoconiosis; glycerine; RCT; SBF; TEWL; SC hydration
• Additional relevant MeSH terms: Elephantiasis; Glycerol

Study Results

Participant Flow

Arm/Group Title	Current Skin Care Regimen	Current Skin Regimen Plus 2% Glycerine
Arm/Group Description	Legs/feet washed daily for 3 months with soapy water, soaked in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.	Legs/feet washed daily for 3 months with soapy water, soaked in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
Period Title: Overall Study
STARTED	97	96
COMPLETED	96	96
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Current Skin Care Regimen	Current Skin Regimen Plus 2% Glycerine	Total
Arm/Group Description	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.	Total of all reporting groups
Overall Participants	97	96	193
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	84 86.6%	82 85.4%	166 86%
>=65 years	13 13.4%	14 14.6%	27 14%
Gender (Count of Participants)
Female	49 50.5%	49 51%	98 50.8%
Male	48 49.5%	47 49%	95 49.2%
Region of Enrollment (participants) [Number]
Ethiopia	97 100%	96 100%	193 100%
Severity of podoconioisis based on a staging systeme (participants) [Number]
Less severe/moderate disease	47 48.5%	46 47.9%	93 48.2%
Severe disease	50 51.5%	50 52.1%	100 51.8%

Outcome Measures

1. Primary Outcome

Title	Change in TEWL at Top of Outer Lower Legs
Description	Trans-epidermal water loss (TEWL) was measured with a Vapometer (non-invasive probe) on the outer lower leg 8 cms below the head of the fibula. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.
Time Frame	Change from baseline following 3 months of intervention

Outcome Measure Data

Analysis Population Description

3 month post intervention data was missing from one male participant in the control group. One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.

Arm/Group Title	Control Group	Experimental Group
Arm/Group Description	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
Measure Participants	97	96
Measure Legs	193	190
Right leg TEWL at 1st visit	12.74 (4.73)	13.43 (5.56)
Left leg TEWL at 1st visit	13.52 (5.61)	13.27 (4.91)
Right leg TEWL at 4th visit	8.76 (2.63)	7.06 (1.96)
Left leg TEWL at 4th visit	9.09 (2.63)	7.53 (2.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Experimental Group
	Comments	The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function (SBF) in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen. Statistical analysis compared the changes in TEWL at the top of the outer lower legs by group from baseline after 3 months of interventions.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	t=5.341, df=89.347
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.581
	Confidence Interval	(2-Sided) 95%; 0.997 to 2.164
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.296
	Estimation Comments

2. Primary Outcome

Title	Change in TEWL at Mid-point Outer Lower Legs
Description	Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the outer lower leg. This was mid-way between the measurement site at the top of the outer leg and the site at the base of the outer lower leg. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.
Time Frame	Change from baseline following 3 months of intervention

Outcome Measure Data

Analysis Population Description

3 month post intervention data missing from one male participant in the control group. One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.

Arm/Group Title	Control Group	Experimental Group
Arm/Group Description	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
Measure Participants	97	96
Measure Legs	193	190
Right leg TEWL at 1st visit	14.02 (5.12)	14.57 (6.03)
Left leg TEWL at 1st visit	15.46 (6.07)	14.55 (5.12)
Right leg TEWL at 4th visit	9.87 (2.86)	8.22 (2.27)
Left leg TEWL at 4th visit	10.34 (3.27)	8.61 (2.43)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Experimental Group
	Comments	The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen. Statistical analysis compared the changes in TEWL at the mid-point of the outer lower legs by group from baseline after 3 months of interventions.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	t=4.871, df=189.789
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.684
	Confidence Interval	(2-Sided) 95%; 1.002 to 2.367
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.346
	Estimation Comments

3. Primary Outcome

Title	Change in TEWL at Base of Outer Lower Legs
Description	Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the outer lower leg 8cms above the external malleolus. A reduction in TEWL indicates a positive effect on skin barrier function.It is generally recommended that differences or percentage changes are reported rather than absolute values. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.
Time Frame	Change from baseline following 3 months of intervention

Outcome Measure Data

Analysis Population Description

3 month post-intervention data was missing from one male participant in control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.

Arm/Group Title	Control Group	Experimental Group
Arm/Group Description	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
Measure Participants	97	96
Measure Legs	193	190
Right leg TEWL at 1st visit	16.45 (6.13)	16.80 (6.79)
Left leg TEWL at 1st visit	17.32 (5.46)	17.02 (5.98)
Right leg TEWL at 4th visit	11.50 (3.35)	9.30 (2.56)
Left leg TEWL at 4th visit	11.87 (3.59)	9.88 (2.27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Experimental Group
	Comments	The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen. Statistical analysis compared the changes in TEWL at the base of the outer lower legs by group from baseline after 3 months of interventions.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	t=5.111, df=189.620
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.970
	Confidence Interval	(2-Sided) 95%; 1.210 to 2.731
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.386
	Estimation Comments

4. Primary Outcome

Title	Change in TEWL at Top of Feet
Description	Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the top of the foot. A reduction in TEWL indicates a positive effect on skin barrier function.It is generally recommended that differences or percentage changes are reported rather than absolute values. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.
Time Frame	Change from baseline following 3 months of intervention

Outcome Measure Data

Analysis Population Description

3 month post intervention data missing from one male participant in control group. One left foot leg in the control group and one right and one left foot in the experimental group was not affected by podoconiosis so they were not included in the study.

Arm/Group Title	Control Group	Experimental Group
Arm/Group Description	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
Measure Participants	97	96
Measure Feet	193	190
Right foot 1st visit	21.97 (5.46)	22.88 (6.74)
Left foot 1st visit	23.01 (5.06)	22.47 (6.79)
Right foot 4th visit	14.90 (4.36)	13.15 (3.87)
Left foot 4th visit	15.38 (4.09)	13.49 (3.77)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Experimental Group
	Comments	The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen. Statistical analysis compared the changes in TEWL at the top of the feet by group from baseline after 3 months of interventions.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Mixed Models Analysis
	Comments	t=3.154, df=189.580
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.751
	Confidence Interval	(2-Sided) 95%; 0.656 to 2.846
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.390
	Estimation Comments

5. Primary Outcome

Title	Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs
Description	Stratum corneum hydration was measured at a specific point at top of outer lower leg (8cms below the head of the fibula) with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.
Time Frame	Change from baseline following 3 months of intervention

Outcome Measure Data

Analysis Population Description

3 month post intervention data missing from one male participant in control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.

Arm/Group Title	Control Group	Experimental Group
Arm/Group Description	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
Measure Participants	97	96
Measure Legs	193	190
Right leg SCH 1st visit	9.60 (3.96)	9.05 (3.98)
Left leg SCH 1st visit	9.82 (4.54)	9.25 (4.09)
Right leg SCH 4th visit	13.73 (3.59)	16.24 (3.72)
Left leg SCH 4th visit	15.30 (11.19)	16.10 (4.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Experimental Group
	Comments	The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen. Statistical analysis compared the changes in SCH at the top of the outer lower legs by group from baseline after 3 months of interventions.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	t=-4.236,df=165.310
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.075
	Confidence Interval	(2-Sided) 95%; -3.042 to -1.1078
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.515
	Estimation Comments

6. Primary Outcome

Title	Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg.
Description	SCH was measured mid-way between the measurement site at the top of the outer leg and the site at the base of the outer lower leg. It was measured with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.
Time Frame	Change from baseline following 3 months of intervention

Outcome Measure Data

Analysis Population Description

3 month post intervention data missing from one male participant in the control group.One left leg in the control group and one right and one left leg in the experimental group were not affected by podoconiosis so they were not included in the study.

Arm/Group Title	Control Group	Experimental Group
Arm/Group Description	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
Measure Participants	97	96
Measure Legs	193	190
Right leg SCH at 1st visit	9.20 (3.29)	8.86 (4.08)
Left leg SCH at 1st visit	9.39 (3.83)	9.05 (3.78)
Right leg SCH at 4th visit	13.88 (2.78)	15.90 (3.77)
Left leg SCH at 4th visit	14.56 (3.90)	15.95 (3.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Experimental Group
	Comments	The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen. Statistical analysis compared the changes in SCH at the mid-point of the outer lower legs by group from baseline after 3 months of interventions.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	t=-3.549, df=180.923
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.658
	Confidence Interval	(2-Sided) 95%; -2.581 to -0.736
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.467
	Estimation Comments

7. Primary Outcome

Title	Change in Stratum Corneum Hydration at Base of Outer Lower Leg
Description	Stratum corneum hydration was measured at the base of the outer lower leg 8 cms above the external malleolus. It was measured with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.
Time Frame	Change from baseline following 3 months of intervention

Outcome Measure Data

Analysis Population Description

3 month data missing from one male participant in control group.One left leg in the control group and one right and one left leg in the experimental group were not affected by podoconiosis so they were not included in the study.

Arm/Group Title	Control Group	Experimental Group
Arm/Group Description	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
Measure Participants	97	96
Measure Legs	193	190
Right leg SCH 1st visit	8.46 (3.95)	8.56 (4.66)
Left leg SCH at 1st visit	8.26 (4.01)	8.85 (4.36)
Right leg SCH 4th visit	14.25 (3.84)	15.93 (3.80)
Left leg SCH 4th visit	14.47 (4.41)	16.47 (3.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Experimental Group
	Comments	The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen. Statistical analysis compared the changes in SCH at the base of the outer lower legs by group from baseline after 3 months of interventions.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Mixed Models Analysis
	Comments	t=-3.471, df=186.308
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.641
	Confidence Interval	(2-Sided) 95%; -2.574 to -0.708
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.473
	Estimation Comments

8. Primary Outcome

Title	Change in Stratum Corneum Hydration at Top of Feet
Description	Stratum corneum hydration measured at a specific point on the middle top of the foot with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.
Time Frame	Change from baseline following 3 months of intervention

Outcome Measure Data

Analysis Population Description

3 month post intervention data missing from one male participant in the control group. One left foot in the control group and one left and one right foot in the experimental group were not affected by podoconiosis so they were not included in the study.

Arm/Group Title	Control Group	Experimental Group
Arm/Group Description	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
Measure Participants	97	96
Measure Feet	193	190
Right leg SCH at 1st visit	8.48 (5.52)	8.50 (6.30)
Left leg SCH at 1st visit	8.39 (5.97)	8.87 (6.72)
Right leg SCH at 4th visit	15.31 (4.54)	17.29 (4.59)
Left leg SCH 4th visit	15.14 (4.92)	17.47 (4.90)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Experimental Group
	Comments	The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen. Statistical analysis compared the changes in SCH at the base of the top of the feet by group from baseline after 3 months of interventions.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	t=-3.565, df=186.739
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.041
	Confidence Interval	(2-Sided) 95%; -3.168 to -0.911
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.572
	Estimation Comments

9. Secondary Outcome

Title	Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit
Description	Podoconiosis Staging System (1-5) used with 5 the most severe stage. This staging system was specifically designed for those with podoconiosis. Legs with stages 1, 2 or 3 were categorised with mild/moderate disease and those with stages 4,5 with severe disease.
Time Frame	Change from baseline following 3 months of intervention

Outcome Measure Data

Analysis Population Description

3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data were pre-specified to be collected and analysed for all participants as a single group.

Arm/Group Title	Stage of Podoconiosis 1st Visit	Stage of Podoconiosis 4th Visit
Arm/Group Description	The number of legs with each stage of podoconiosis (1-5) and those with no disease	The number of legs with each stage of podoconiosis (1-5) and those with no disease
Measure Participants	193	192
Measure Legs	383	381
Right leg stage nil	2	2
Left legs stage nil	1	1
Right legs stage 1	22	56
Left legs stage 1	20	49
Right leg stage 2	63	50
Left leg stage 2	66	53
Right leg stage 3	19	64
Left leg stage 3	17	68
Right leg stage 4	72	29
Left leg stage 4	75	21
Right leg stage 5	15	0
Left leg stage 5	14	0
Right leg missing data	0	1
Left leg missing data	0	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Experimental Group
	Comments	The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen. Statistical analysis calculated the odds of the stage of podoconiosis by group being more severe at the 4th visit.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.076
	Comments	A cumulative logistic link function was used
	Method	Generalized estimating equation analysis
	Comments	Wald Chi squared=3.138, df=1
Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	0.452
	Confidence Interval	(2-Sided) 95%; -0.048 to 0.952
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.255
	Estimation Comments

10. Secondary Outcome

Title	Total Number of Trophic Skin Changes (Mossy Changes) All Participants at Baseline and 4th Visit
Description	Total number of observed trophic changes (mossy eruptions on the skin of the lower legs/feet characteristic of podoconiosis) in all participants by clinic nurse at baseline and at 4th visit. Trophic changes were either present or not present.
Time Frame	Change from baseline following 3 months of intervention

Outcome Measure Data

Analysis Population Description

3 month post intervention data missing from one male participant in the control group.One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data were pre-specified to be collected and analysed for all participants in a single group.

Arm/Group Title	Total Number of Trophic Skin Changes at Baseline	Total Number of Trophic Skin Changes at 4th Visit
Arm/Group Description	Trophic (mossy) skin changes on the lower legs/feet are a characteristic of podoconiosis. The total number of all participants with trophic changes in their lower legs/feet is reported.	Trophic (mossy) skin changes on the lower legs/feet are a characteristic of podoconiosis. The total number of all participants with trophic changes in their lower legs/feet is reported. A reduction in the number of legs/feet with mossy changes would denote an improvement in the condition.
Measure Participants	193	192
Number [Trophic skin changes]	312	237

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Experimental Group
	Comments	The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen. Statistical analysis calculated the odds of mossy changes being present in the lower legs/feet by group at the 4th visit.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.527
	Comments	A Bernouilli distribution with a logistic link function was used.
	Method	Generalized estimating equation analysis
	Comments	Wald chi-square=0.410, df=1
Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	-0.224
	Confidence Interval	(2-Sided) 95%; -0.469 to 0.917
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Total Number of All Participants With the Presence of a Bad Odour Emanating From Their Lower Limbs.
Description	Change in the presence of bad odour emanating from wounds on participant's lower legs/feet as determined by clinic nurse. Bad odour results in social stigma and impacts of quality of life.
Time Frame	Change from baseline following 3 months of intervention

Outcome Measure Data

Analysis Population Description

3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data were pre-specified to be collected and analysed for all participants in a single group.

Arm/Group Title	Participants With Bad Odour From Legs/Feet at Baseline	Participants With Bad Odour From Legs/Feet at 4th Visit
Arm/Group Description	Presence of a bad odour emanating from legs/feet of all participants as determined by clinic nurse.	Presence of a bad odour emanating from legs/feet of all participants as determined by clinic nurse.
Measure Participants	193	192
Number [Participants]	114 117.5%	3 3.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Experimental Group
	Comments	The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen. Statistical analysis calculated the odds of participants having a bad odour emanating from their lower legs/feet by group at the 4th visit. Bad odour results in a decease in quality of life.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.031
	Comments	A Bernouilli distribution with a logistic link function was used
	Method	Generalized estimating equation analysis
	Comments	Wald chi-square=8.304, df=1
Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	-1.29
	Confidence Interval	(2-Sided) 95%; -2.161 to -0.411
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.446
	Estimation Comments

12. Secondary Outcome

Title	Number of Wounds on Lower Legs/Feet of Participants.
Description	Observation and count of number of wounds (all breaches of the stratum corneum including areas of fungal infection) on lower legs/feet by clinic nurse. Breaches in the skin and areas of fungal infection are more likely to occur in those with an impaired skin barrier function.A reduction in the number of wounds indicates an improvement in SBF.
Time Frame	Change from baseline following 3 months of intervention

Outcome Measure Data

Analysis Population Description

3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data was pre-specified to be analysed for all participants as a single group.

Arm/Group Title	Number of Wounds at Baseline	Number of Wounds 4th Visit
Arm/Group Description	The total number of wounds (skin breaches including areas of fungal infection) of all participants on all legs/feet at baseline.	The total number of wounds (skin breaches including areas of fungal infection) of all participants on all legs/feet at 4th visit.
Measure Participants	193	192
Measure Feet/legs	383	381
Number [Wounds]	962	29

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Experimental Group
	Comments	The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen. Statistical analysis calculated the odds of wounds being present on the lower legs/feet of participants by group at the 4th visit.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments	A Poisson distribution with a logarithmic link function was used
	Method	Generalized estimating equation analysis
	Comments	Wald chi-square=7.745, df=1
Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	2.062
	Confidence Interval	(2-Sided) 95%; 0.610 to 3.514
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.741
	Estimation Comments

13. Secondary Outcome

Title	Change in Number of Work Days Lost in Previous Month Due to Adenolymphangitis (ADL)
Description	Verbal questioning of participants by clinic nurse or social worker as to number of work days lost due to severe leg pain (adenolymphangitis). Questioning was used as most participants were illiterate.
Time Frame	Change from baseline following 3 months of intervention

Outcome Measure Data

Analysis Population Description

3 month post intervention data missing from one male participant in the control group.One leg in the control group and two legs in experimental group were not affected by podoconiosis.Data were pre-specified to be analysed for all participants as a single group.

Arm/Group Title	Number of Days Work Days Lost by All Participants Baseline	Number of Days Lost by All Participants at 4th Visit
Arm/Group Description	Number of days work lost in previous month due to adeno-lymphangitis. Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.	Number of days work lost in previous month due to adeno-lymphangitis. Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
Measure Participants	193	192
Number [Number of work days lost.]	868	9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group
	Comments	The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen. Statistical analysis calculated the odds by group of having had fewer work days lost in the previous month at the 4th visit due to ADL.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.058
	Comments	A Poisson distribution with a logarithmic link function was used.
	Method	Generalized estimation equation
	Comments	df=1
Method of Estimation	Estimation Parameter	Group ratio estimate
	Estimated Value	2.090
	Confidence Interval	(2-Sided) 0.058%; -0.069 to 4.250
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.102
	Estimation Comments	Those in the experimental group were expected to have fewer work days lost due to ADL.

14. Secondary Outcome

Title	Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds
Description	Statistical calculation of the correlation between the number of work days lost in the previous month due to leg pain (adenolymphangitis) and the number of wounds present on the lower leg/foot. Wounds on the lower legs/feet may produce a bad odour.
Time Frame	From baseline monthly for 3 months

Outcome Measure Data

Analysis Population Description

3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis.Data were pre-specified to be collected and analysed for all participants in a single group.

Arm/Group Title	Correlation Between Number of Wounds and Days Lost Due to ADL
Arm/Group Description	Correlation between nuumber of work days lost in previous month due to ADL and number of wounds (all skin breaches including areas of fungal infection)
Measure Participants	193
Correlation at baseline	0.252
Correlation at 2nd visit	0.306
Correlation at 3rd visit	0.291
Correlation at 4th visit	0.265

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group
	Comments	The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The p value was < 0.001 at all time points.
	Method	Spearman's correlation coefficient
	Comments	The correlation at the 1st visit was 0.252, at the 2nd 0.306, at the 3rd 0.291 and at the 4th 0.265.

15. Secondary Outcome

Title	Change in Largest Lower Leg Circumference
Description	Measured by clinic nurse in centimetres with a disposable tape measure at the point of largest circumference on the foot.
Time Frame	Change from baseline following 3 months of intervention

Outcome Measure Data

Analysis Population Description

3 month post intervention data missing from one male participant in the control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.

Arm/Group Title	Control Group	Experimental Group
Arm/Group Description	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
Measure Participants	97	96
Measure Legs	193	190
Mean (Standard Deviation) [Centimetres]	-3.86 (2.82)	-4.14 (1.74)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Experimental Group
	Comments	The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen. A reduction in leg circumference indicates an improvement in the disease.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.158
	Comments
	Method	Mixed Models Analysis
	Comments	df=185.386
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	0.288
	Confidence Interval	(2-Sided) 95%; -0.113 to 0.690
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.204
	Estimation Comments

16. Secondary Outcome

Title	Change in Largest Foot Circumference
Description	Measured by clinic nurse in centimetres with a disposable tape measure at the point of largest circumference on the foot
Time Frame	Change from baseline following 3 months of intervention

Outcome Measure Data

Analysis Population Description

3 month post intervention data missing from one male participant in the control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.

Arm/Group Title	Control Group	Experimental Group
Arm/Group Description	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
Measure Participants	97	96
Measure Foot circumference	193	190
Mean (Standard Deviation) [Centimetres]	-2.34 (2.73)	-2.90 (1.93)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Experimental Group
	Comments	The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen. A reduction in foot circumference indicates an improvement in the disease.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments	df=169.916, t=3.550
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.575
	Confidence Interval	(2-Sided) 95%; 0.255 to 0.895
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.162
	Estimation Comments

17. Secondary Outcome

Title	Amharic Dermatology Life Quality Index (DLQI)
Description	The Amharic version of the DLQI has been validated for use in Ethiopia where Amharic is the official working language. The index is divided into 4 sections covering leisure, work and school, personal relationships and treatment. The maximum score of 30 indicates a high impact on quality of life. The lowest score zero. A reduction in the number indicates an improvement in quality of life. Participants were verbally questioned by the clinic nurse or social worker as most participants were illiterate.
Time Frame	Change from baseline following 3 months of intervention

Outcome Measure Data

Analysis Population Description

3 month post intervention data missing from one male participant in the control group.

Arm/Group Title	Control Group	Experimental Group
Arm/Group Description	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
Measure Participants	97	96
DLQI at baseline	21.61 (5.82)	21.07 (7.49)
DLQI 4th visit	4.12 (4.29)	3.94 (3.82)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Experimental Group
	Comments	The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen. Podoconiosis has a large effect on a person's quality of life. abnormal looking legs/feet, wounds and the related bad odour plus social isolation result in stigma and social isolation..
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.907
	Comments
	Method	Mixed Models Analysis
	Comments	t=-0.117, df=178.814
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.063
	Confidence Interval	(2-Sided) 95%; -1.129 to 1.002
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.540
	Estimation Comments

Adverse Events

Time Frame	3 months
Adverse Event Reporting Description	Any adverse effects of the regimes on the skin of the lower legs/feet of all participants were noted by the clinic nurse.
Arm/Group Title	Control Group		Experimental Group
Arm/Group Description	Legs/feet washed daily for 3 months with soapy water, soaked in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.		Legs/feet washed daily for 3 months with soapy water, soaked in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
All Cause Mortality
	Control Group		Experimental Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control Group		Experimental Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/97 (0%)		0/96 (0%)
Other (Not Including Serious) Adverse Events
	Control Group		Experimental Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/97 (0%)		0/96 (0%)

Limitations/Caveats

The study was not blinded which would have strengthened credibility and limited bias.The groups were matched but factors such as diet and co-morbidities particularly relating to blood flow in the legs/feet were not collected.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.