DFE: Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures

• Sponsor: Temple University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01941719
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 99
• Location: 1
• Arms: 2
• Actual Duration (Months): 46.4
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the effectiveness of a novel patient education strategy, compared to a standard diabetic foot education. The proposed diabetic foot care education uses personal computer-animated plantar pressure data to educate patients on why and how they should care for their feet.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus; Diabetic Neuropathies; Foot Complications	Behavioral: Enhanced foot care education; Behavioral: Standard Foot Care Education	N/A

Detailed Description

Using block randomization, subjects with diabetes were assigned to either the standard or the enhanced education group. The effectiveness of enhanced education was evaluated as measured by foot care behavior score, patient's interpretation of neuropathy scores, and the incidence of diabetic foot complications over a course of 1-year.

Study Design

• Study Type: Interventional
• Actual Enrollment: 99 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures
• Actual Study Start Date: May 2, 2008
• Actual Primary Completion Date: Sep 7, 2011
• Actual Study Completion Date: Mar 14, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: enhanced foot care education In addition to the standard diabetic foot self-care instruction, the importance of daily foot self-care was reinforced at baseline by viewing personal barefoot plantar pressure in gait	Behavioral: Enhanced foot care education; In addition to the standard foot care education, personalized, computer-animated plantar pressure maps in both barefoot and in-shoe conditions were demonstrated once at baseline visit. The demonstration includes diabetic foot education on the topic of diabetic neuropathy and how barefoot walking can lead to skin breakdown and ulcer formation, which can lead to infection and eventual amputation. The education also highlights the high plantar pressures experienced by individuals while barefoot versus in-shoe and how proper footwear is necessary in conjunction with other standard self-foot care measures to prevent injury and complications.
Active Comparator: Standard Foot Care Education Reviewed the standard diabetic foot self-care instructions, including daily foot inspection and proper footwear at all times.	Behavioral: Standard Foot Care Education; At baseline, a trained staff individually reviewed and dispensed the following brochures: "Prevent diabetes problems: Keep your diabetes under control" (NIH Publication No. 07-4349) and "Prevent diabetes problems: Keep your feet and skin healthy" (NIH Publication No. 07-4282) along with a 1-page summary of each brochure. Also, a 1-page supplementary diabetic shoe wear educational material was reviewed and dispensed. "Keep your diabetes under control" stresses "sugar, blood pressure, and medication control, and nutrition and physical activity, and checking feet daily for cuts, blisters, sores, swelling, redness, or sore toenails." "Keep your skin and feet healthy" emphasizes the importance of checking feet daily, highlighting diabetic foot complications that can arise from neuropathy, poor circulation and dry skin, and the importance of supportive, protective, and accommodative shoewear and annual foot exams.

Outcome Measures

Primary Outcome Measures

1. Foot Care Behavior Score [baseline, 1, 3,6,9 and 12 months]

   Daily foot inspection - number (& % of participants) of participants who inspect their feet at least daily

2. Patient Interpretation of Neuropathy (PIN) Questionnaire [Baseline, months 1, 3, 6, and 12.]

   Participants who demonstrated an accurate interpretation of diabetic peripheral neuropathy (id2). The score range from 1 (correct interpretation) to 5 (misinterpretation)

Secondary Outcome Measures

1. Foot Complications [1 year]

   Number of participants with foot complications

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female between the ages of 21 and 75 years (inclusive)

• Documented type 1 or type 2 diabetes mellitus

• Demonstrates peripheral neuropathy (defined as vibration perception threshold (VPT) ≥ 25 volts at the hallux, as quantified by a BioThesiometer, or unable to perceive a 10 gram Semmes-Weinstein monofilament in one four sites on the feet)

• Able to walk independently without the use of walking aids (cane, crutches, or walker)

• Able to speak and understand English

• Able to understand the information in the informed consent form and willing and able to sign the consent form

Exclusion Criteria:

• Amputation of either foot proximal to midfoot

• Presence of cutaneous ulceration in the lower extremity

• History of or active Charcot neuroarthropathy of either foot

• Severe peripheral vascular disease (ie. ischemic rest pain, 2-block claudication or gangrene)

• End stage kidney disease requiring hemodialysis, stroke, or widespread malignant disease

• Pregnant or nursing

• Life expectancy < 12 months

• Not willing or able to make the required follow-up visits

• Insufficient (corrected) vision to complete the questionnaires

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gait Study Center; Temple University School of Podiatric Medicine	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Temple University
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Jinsup Song, DPM, PhD, Temple University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Temple University
• ClinicalTrials.gov Identifier: NCT01941719
• Other Study ID Numbers: 11447; K23DK081021
• First Posted: Sep 13, 2013
• Last Update Posted: Dec 7, 2021
• Last Verified: Nov 1, 2021

• Keywords provided by Temple University: Diabetes Mellitus; Diabetic Foot; Diabetic Peripheral Neuropathy; Diabetic Foot Education
• Additional relevant MeSH terms: Diabetic Neuropathies; Diabetic Foot; Diabetes Mellitus

Study Results

Participant Flow

Arm/Group Title	Standard Foot Care Education	Enhanced Foot Care Education
Arm/Group Description	Standard Foot Care Education: At baseline, a trained staff individually reviewed and dispensed the following brochures: "Prevent diabetes problems: Keep your diabetes under control" (NIH Publication No. 07-4349) and "Prevent diabetes problems: Keep your feet and skin healthy" (NIH Publication No. 07-4282). In addition, a 1-page diabetic footwear selection criteria is provided.	In addition to the standard diabetic foot educational brochure, the importance of daily foot self-care was reinforced by viewing personal barefoot plantar pressure
Period Title: Overall Study
STARTED	48	51
Month 1	43	48
Month 3	38	44
Month 6	34	42
Month 9	29	37
Month 12	28	32
COMPLETED	28	32
NOT COMPLETED	20	19

Baseline Characteristics

Arm/Group Title	Standard Foot Care Education	Enhanced Foot Care Education	Total
Arm/Group Description	Standard Foot Care Education: At baseline, a trained staff individually reviewed and dispensed the following brochures: "Prevent diabetes problems: Keep your diabetes under control" (NIH Publication No. 07-4349) and "Prevent diabetes problems: Keep your feet and skin healthy" (NIH Publication No. 07-4282) along with a 1-page summary of each brochure. Also, a 1-page supplementary diabetic shoe wear educational material was reviewed. "Keep your diabetes under control" stresses "sugar, blood pressure, and medication control, and nutrition and physical activity, and checking feet daily for cuts, blisters, sores, swelling, redness, or sore toenails." "Keep your skin and feet healthy" emphasizes the importance of checking feet daily, highlighting diabetic foot complications that can arise from neuropathy, poor circulation and dry skin, and the importance of supportive, protective, and accommodative shoewear and annual foot exams.	In addition to the standard diabetic foot educational brochure, the importance of daily foot self-care was reinforced by viewing personal barefoot plantar pressure Personalized, computer-animated plantar pressure maps in both barefoot and in-shoe conditions were demonstrated at baseline visit. Investigator explained how excessive barefoot pressure can lead to skin breakdown and ulcer formation. The education also highlights the benefit of proper footwear and self-foot care measures to prevent injury and complications.	Total of all reporting groups
Overall Participants	48	51	99
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.0 (9.5)	55.9 (10.2)	54.5 (10.0)
Sex: Female, Male (Count of Participants)
Female	18 37.5%	20 39.2%	38 38.4%
Male	30 62.5%	31 60.8%	61 61.6%
Region of Enrollment (participants) [Number]
United States	48 100%	51 100%	99 100%

Outcome Measures

1. Primary Outcome

Title	Foot Care Behavior Score
Description	Daily foot inspection - number (& % of participants) of participants who inspect their feet at least daily
Time Frame	baseline, 1, 3,6,9 and 12 months

Outcome Measure Data

Analysis Population Description

Fewer participants at follow up visits due to drop out

Arm/Group Title	Standard Foot Care Education	Enhanced Foot Care Education
Arm/Group Description	Standard Foot Care Education: At baseline, a trained staff individually reviewed and dispensed the following brochures: "Prevent diabetes problems: Keep your diabetes under control" (NIH Publication No. 07-4349) and "Prevent diabetes problems: Keep your feet and skin healthy" (NIH Publication No. 07-4282). Also, a 1-page supplementary diabetic footwear educational material was reviewed. The aims of education are to emphasize the importance of checking feet daily, highlighting diabetic foot complications that can arise from repetitive trauma and inappropriate footwear in the absence of protective sensation.	In addition to the standard diabetic foot educational brochure, the importance of daily foot self-care was reinforced by viewing personal barefoot plantar pressure Personalized, computer-animated plantar pressure maps in both barefoot and in-shoe conditions were demonstrated at baseline visit. Investigator explained how excessive barefoot pressure can lead to skin breakdown and ulcer formation. The education also highlights the benefit of proper footwear and self-foot care measures to prevent injury and complications.
Measure Participants	48	51
daily foot inspection_baseline	29 60.4%	36 70.6%
daily foot inspection_baselinescore_month 1	33 68.8%	42 82.4%
daily foot inspection_baselinescore_month 3	27 56.3%	40 78.4%
daily foot inspection_baselinescore_month 6	24 50%	35 68.6%
daily foot inspection_baselinescore_month 9	19 39.6%	31 60.8%
daily foot inspection_baselinescore_month 12	14 29.2%	19 37.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Foot Care Education, Enhanced Foot Care Education
	Comments	A mixed-effect model with repeated measures is used to compare the difference of group over time.
	Type of Statistical Test	Equivalence
	Comments	This trial aims to show the enhanced education is no better and no worse than the standard education
Statistical Test of Hypothesis	p-Value	0.0770
	Comments	significance level set at 0.05
	Method	ANCOVA
	Comments	At each follow-up point, multivariate ANCOVA models were used to test for significant changes from the baseline
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1212
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Patient Interpretation of Neuropathy (PIN) Questionnaire
Description	Participants who demonstrated an accurate interpretation of diabetic peripheral neuropathy (id2). The score range from 1 (correct interpretation) to 5 (misinterpretation)
Time Frame	Baseline, months 1, 3, 6, and 12.

Outcome Measure Data

Analysis Population Description

Fewer participants in follow up visits due to drop out

Arm/Group Title	Standard Foot Care Education	Enhanced Foot Care Education
Arm/Group Description	Standard Foot Care Education: At baseline, a trained staff individually reviewed and dispensed the following brochures: "Prevent diabetes problems: Keep your diabetes under control" (NIH Publication No. 07-4349) and "Prevent diabetes problems: Keep your feet and skin healthy" (NIH Publication No. 07-4282) along with a 1-page summary of each brochure. Also, a 1-page supplementary diabetic shoe wear educational material was reviewed. "Keep your diabetes under control" stresses "sugar, blood pressure, and medication control, and nutrition and physical activity, and checking feet daily for cuts, blisters, sores, swelling, redness, or sore toenails." "Keep your skin and feet healthy" emphasizes the importance of checking feet daily, highlighting diabetic foot complications that can arise from neuropathy, poor circulation and dry skin, and the importance of supportive, protective, and accommodative shoewear and annual foot exams.	In addition to the standard diabetic foot educational brochure, the importance of daily foot self-care was reinforced by viewing personal barefoot plantar pressure Personalized, computer-animated plantar pressure maps in both barefoot and in-shoe conditions were demonstrated at baseline visit. Investigator explained how excessive barefoot pressure can lead to skin breakdown and ulcer formation. The education also highlights the benefit of proper footwear and self-foot care measures to prevent injury and complications.
Measure Participants	48	51
id2, baseline	3.86 (0.66)	3.86 (0.68)
id2, month 1	3.86 (0.70)	3.83 (0.80)
id2, month 3	3.77 (0.76)	3.95 (0.77)
id2, month 6	3.63 (0.84)	3.87 (0.70)
id2, month 9	3.83 (0.69)	3.96 (0.61)
id2, month 12	3.71 (0.73)	3.91 (0.52)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Foot Care Education, Enhanced Foot Care Education
	Comments
	Type of Statistical Test	Equivalence
	Comments	This trial aims to show the new treatment is no better and no worse
Statistical Test of Hypothesis	p-Value	0.6638
	Comments	The threshold of significance level set at 0.05
	Method	Mixed Models Analysis
	Comments

3. Secondary Outcome

Title	Foot Complications
Description	Number of participants with foot complications
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Foot Care Education	Enhanced Foot Care Education
Arm/Group Description	Standard Foot Care Education: At baseline, a trained staff individually reviewed and dispensed the following brochures: "Prevent diabetes problems: Keep your diabetes under control" (NIH Publication No. 07-4349) and "Prevent diabetes problems: Keep your feet and skin healthy" (NIH Publication No. 07-4282) along with a 1-page summary of each brochure. Also, a 1-page supplementary diabetic shoe wear educational material was reviewed. "Keep your diabetes under control" stresses "sugar, blood pressure, and medication control, and nutrition and physical activity, and checking feet daily for cuts, blisters, sores, swelling, redness, or sore toenails." "Keep your skin and feet healthy" emphasizes the importance of checking feet daily, highlighting diabetic foot complications that can arise from neuropathy, poor circulation and dry skin, and the importance of supportive, protective, and accommodative shoewear and annual foot exams.	In addition to the standard diabetic foot educational brochure, the importance of daily foot self-care was reinforced by viewing personal barefoot plantar pressure Personalized, computer-animated plantar pressure maps in both barefoot and in-shoe conditions were demonstrated at baseline visit. Investigator explained how excessive barefoot pressure can lead to skin breakdown and ulcer formation. The education also highlights the benefit of proper footwear and self-foot care measures to prevent injury and complications.
Measure Participants	48	51
pre-ulcerative lesions	7 14.6%	11 21.6%
foot ulcer	3 6.3%	3 5.9%
subungual hematoma	13 27.1%	6 11.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Foot Care Education, Enhanced Foot Care Education
	Comments
	Type of Statistical Test	Equivalence
	Comments	The test will compare the number of complications between the two groups
Statistical Test of Hypothesis	p-Value	< 0.05
	Comments
	Method	ANOVA
	Comments

Adverse Events

Time Frame	1 year
Arm/Group Title	Standard Foot Care Education		Enhanced Foot Care Education
Arm/Group Description	Standard Foot Care Education: At baseline, a trained staff individually reviewed and dispensed the following brochures: "Prevent diabetes problems: Keep your diabetes under control" (NIH Publication No. 07-4349) and "Prevent diabetes problems: Keep your feet and skin healthy" (NIH Publication No. 07-4282) along with a 1-page summary of each brochure. Also, a 1-page supplementary diabetic shoe wear educational material was reviewed. "Keep your diabetes under control" stresses "sugar, blood pressure, and medication control, and nutrition and physical activity, and checking feet daily for cuts, blisters, sores, swelling, redness, or sore toenails." "Keep your skin and feet healthy" emphasizes the importance of checking feet daily, highlighting diabetic foot complications that can arise from neuropathy, poor circulation and dry skin, and the importance of supportive, protective, and accommodative shoewear and annual foot exams.		In addition to the standard diabetic foot educational brochure, the importance of daily foot self-care was reinforced by viewing personal barefoot plantar pressure Personalized, computer-animated plantar pressure maps in both barefoot and in-shoe conditions were demonstrated at baseline visit. Investigator explained how excessive barefoot pressure can lead to skin breakdown and ulcer formation. The education also highlights the benefit of proper footwear and self-foot care measures to prevent injury and complications.
All Cause Mortality
	Standard Foot Care Education		Enhanced Foot Care Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/51 (0%)
Serious Adverse Events
	Standard Foot Care Education		Enhanced Foot Care Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/51 (0%)
Infections and infestations
cellulitis, foot	0/48 (0%)	0	0/51 (0%)	0
lower limb amputation	0/48 (0%)	0	0/51 (0%)	0
Other (Not Including Serious) Adverse Events
	Standard Foot Care Education		Enhanced Foot Care Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/48 (43.8%)		30/51 (58.8%)
Cardiac disorders
Hospitalization	8/48 (16.7%)	8	12/51 (23.5%)	12
Skin and subcutaneous tissue disorders
diabetic foot ulcer	3/48 (6.3%)	3	3/51 (5.9%)	3
Pre-ulcerative lesion	7/48 (14.6%)	7	11/51 (21.6%)	11
Ingrown	3/48 (6.3%)	3	4/51 (7.8%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.