The Effect of the Cosmetic Cream NMBM on Leg Ulcers - a Pilot Study

• Sponsor: M.D. Lederman Consulting Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01770509
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

Ulcers of the lower extremities, caused by chronic venous insufficiency and cellulitis are common in patients older than 65 years and cause a significant morbidity.

Natural Matrix Bio polymer Membrane (NMBM) is a novel topical cosmetic cream containing a mix of natural waxes, sugars and lipids. The aim of this study is to test whether of Natural Matrix Bio polymer Membrane (NMBM) is effective as an adjunctive therapy to the treatment of venous stasis and post-erysipelas leg ulcers.

Condition or Disease	Intervention/Treatment	Phase
Ulcer; Venous Ulcer; Skin Ulcer; Leg Ulcer	Device: NMBM; Other: Compression garments	Phase 1/Phase 2

Detailed Description

Ulcers of the lower extremities, particularly in patients older than 65 years, are common among the population. Studies estimate the prevalence of current chronic leg ulcers at approximately 1%. The most common cause (approximately 80%) is thought to be chronic venous insufficiency disease. Recurrent cellulitis is an additional common cause. The ulcers cause a significant morbidity and negative impact on the patients' quality of life. The care of chronic vascular ulcers places a significant burden on the patient and the health care system. Additionally, these nonhealing ulcers place the patient at much higher risk for lower extremity amputation.

Natural Matrix Bio polymer Membrane (NMBM) is a novel topical cosmetic cream containing a mix of natural waxes, sugars and lipids. The aim of this study is to test whether of Natural Matrix Bio polymer Membrane (NMBM) is effective as an adjunctive therapy to the treatment of venous stasis and post-erysipelas leg ulcers.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Parallel Group, Controlled Study to Assess the Efficacy and Safety of NMBM in the Treatment of Subjects With a Post-cellulitis and Venous Leg Ulcer
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard of care Standard of care: Dressings +Compression garments	Other: Compression garments; Compression garments
Experimental: Application of NMBM Daily application of NMBM	Device: NMBM; Daily application of NMBM in addition to compression therapy; Other: Compression garments; Compression garments

Outcome Measures

Primary Outcome Measures

1. Logarithm of Percentage of Baseline Ulcer Size [From start of treatment to 4 weeks]

   Logarithm of percentage of baseline ulcer size. Log (ulcer area at 4 weeks/ulcer area at baseline *100) Ulcer area measured as longest ulcer length x longest ulcer width

Secondary Outcome Measures

1. Alleviation of Pain [4 weeks]

   Pain in week 4, assessed by the patient on a visual analogue pain score from 0 to 10. 0 represents no pain, 10 represents worst pain

2. Incidence of Adverse Events at 4 Weeks [4 weeks]

   Number of patients with adverse effects at 4 weeks

3. Incidence of Adverse Events [4 weeks]

   Number of adverse effects at 4 weeks

4. Time to Complete Closure [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Signed and dated written Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved informed consent obtained from the subject in accordance with the local regulations;

2. Male or female subjects, ≥18 to ≤90 years of age

3. Patient with venous or predominantly venous leg ulcer (ankle-brachial index > 0.8)

4. Chronic venous insufficiency or post-erysipelas ulcer

5. Ulcer size between 5 and 170 sq cm, inclusive

6. Ulcer present for at least one month

7. ankle-brachial index >0.7

Exclusion Criteria:

1. Suffers from diabetes mellitus with HbA1c ≥ 8%

2. Albumin less than

3. 1. Patients with the following abnormal laboratory test levels hemoglobin <10.5 g/dL platelet count <100 x 109/L serum albumin level < 2.5 g/dL 3. Suffers from clinically significant arterial disease 34. Has a known allergy to any of the compounds that are part of this protocol 45. Has evidence of the ulcer and / or infection extending to the underlying muscle, tendon or bone 56. Has used any investigational drug(s) within 30 days preceding randomization 67. Is unable to manage self-treatment 78. Is pregnant, nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinence) 8. 9. Suffers from a condition which in the opinion of the Investigator would compromise the safety of the subject and / or the quality of the data 9.

4. Unwilling or unable to comply with study requirements.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Department of Dermatology, Sheba Medical Center	Ramat-Gan		Israel	52621

Sponsors and Collaborators

• M.D. Lederman Consulting Ltd

Investigators

• Principal Investigator: Shoshana Greenberger, MD PhD, The Department of Dermatology, Sheba Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: M.D. Lederman Consulting Ltd
• ClinicalTrials.gov Identifier: NCT01770509
• Other Study ID Numbers: SHEBA -11- 9204-SG-CTIL
• First Posted: Jan 17, 2013
• Last Update Posted: Jan 11, 2017
• Last Verified: Jun 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by M.D. Lederman Consulting Ltd: Chronic venous leg ulcers; Venous ulcer; Stasis ulcer; Varicose ulcer
• Additional relevant MeSH terms: Varicose Ulcer; Leg Ulcer; Skin Ulcer; Ulcer

Study Results

Participant Flow

Arm/Group Title	Standard of Care	Application of NMBM
Arm/Group Description	Standard of care: Dressings +Compression garments Compression garments: Compression garments	Daily application of NMBM NMBM: Daily application of NMBM in addition to compression therapy Compression garments: Compression garments
Period Title: Overall Study
STARTED	12	17
COMPLETED	11	14
NOT COMPLETED	1	3

Baseline Characteristics

Arm/Group Title	Standard of Care	Application of NMBM	Total
Arm/Group Description	Standard of care: Dressings +Compression garments Compression garments: Compression garments	Daily application of NMBM NMBM: Daily application of NMBM in addition to compression therapy Compression garments: Compression garments	Total of all reporting groups
Overall Participants	12	17	29
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	75.54 (7.7)	68.17 (13.9)	70.9 (12.6)
Gender (Count of Participants)
Female	5 41.7%	9 52.9%	14 48.3%
Male	7 58.3%	8 47.1%	15 51.7%
Region of Enrollment (participants) [Number]
Israel	12 100%	17 100%	29 100%

Outcome Measures

1. Primary Outcome

Title	Logarithm of Percentage of Baseline Ulcer Size
Description	Logarithm of percentage of baseline ulcer size. Log (ulcer area at 4 weeks/ulcer area at baseline *100) Ulcer area measured as longest ulcer length x longest ulcer width
Time Frame	From start of treatment to 4 weeks

Outcome Measure Data

Analysis Population Description

Analysis is based on measures from each ulcer, when some participants had more than one ulcer

Arm/Group Title	Standard of Care	Application of NMBM
Arm/Group Description	Standard of care: Dressings +Compression garments Compression garments: Compression garments	Daily application of NMBM NMBM: Daily application of NMBM in addition to compression therapy Compression garments: Compression garments
Measure Participants	11	14
Measure Ulcers	17	19
Mean (Standard Deviation) [Mean of log (percentage of baseline area]	3.6043 (2.16636)	3.5030 (2.11130)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care, Application of NMBM
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.652
	Comments
	Method	ANOVA
	Comments	General Linear Model ANOVA with repeated measures

2. Secondary Outcome

Title	Alleviation of Pain
Description	Pain in week 4, assessed by the patient on a visual analogue pain score from 0 to 10. 0 represents no pain, 10 represents worst pain
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	Application of NMBM
Arm/Group Description	Standard of care: Dressings +Compression garments Compression garments: Compression garments	Daily application of NMBM NMBM: Daily application of NMBM in addition to compression therapy Compression garments: Compression garments
Measure Participants	11	14
Mean (Standard Deviation) [units on a scale]	2.45 (1.29)	1.68 (1.62)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care, Application of NMBM
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.645
	Comments
	Method	ANOVA
	Comments	General Linear Model ANOVA with repeated measures

3. Secondary Outcome

Title	Incidence of Adverse Events at 4 Weeks
Description	Number of patients with adverse effects at 4 weeks
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	Application of NMBM
Arm/Group Description	Standard of care: Dressings +Compression garments Compression garments: Compression garments	Daily application of NMBM NMBM: Daily application of NMBM in addition to compression therapy Compression garments: Compression garments
Measure Participants	11	14
Number [Number of patients with adverse events]	1	3

4. Secondary Outcome

Title	Incidence of Adverse Events
Description	Number of adverse effects at 4 weeks
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	Application of NMBM
Arm/Group Description	Standard of care: Dressings +Compression garments Compression garments: Compression garments	Daily application of NMBM NMBM: Daily application of NMBM in addition to compression therapy Compression garments: Compression garments
Measure Participants	11	14
Number [number of adverse effects]	1	3

5. Secondary Outcome

Title	Time to Complete Closure
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Data was not collected as time to ulcer closure has been beyond the study period in the majority of patients

Arm/Group Title	Standard of Care	Application of NMBM
Arm/Group Description	Standard of care: Dressings +Compression garments Compression garments: Compression garments	Daily application of NMBM NMBM: Daily application of NMBM in addition to compression therapy Compression garments: Compression garments
Measure Participants	0	0

Adverse Events

Arm/Group Title	Standard of Care		Application of NMBM
Arm/Group Description	Standard of care: Dressings +Compression garments Compression garments: Compression garments		Daily application of NMBM NMBM: Daily application of NMBM in addition to compression therapy Compression garments: Compression garments
All Cause Mortality
	Standard of Care		Application of NMBM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard of Care		Application of NMBM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Standard of Care		Application of NMBM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/11 (9.1%)		3/14 (21.4%)
Skin and subcutaneous tissue disorders
local irritation	0/11 (0%)		3/14 (21.4%)
wound infection	1/11 (9.1%)		0/14 (0%)

Limitations/Caveats

[Not Specified]

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.