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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Ulcer, Venous Ulcer, Skin Ulcer, Leg Ulcer

Intervention / Treatment
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* Device: NMBM
* Other: Compression garments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Male or female subjects, ≥18 to ≤90 years of age Patient with venous or predominantly venous leg ulcer (ankle-brachial index > 0.8) Chronic venous insufficiency or post-erysipelas ulcer Ulcer size between 5 and 170 sq cm, inclusive Ulcer present for at least one month ankle-brachial index >0.7 Exclusion Criteria: Suffers from diabetes mellitus with HbA1c ≥ 8% Albumin less than 2. 2. 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. 10. Unwilling or unable to comply with study requirements.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care<br>Standard of care: Dressings +Compression garments | Other: Compression garments<br>* Compression garments<br>|
| Experimental: Application of NMBM<br>Daily application of NMBM | Device: NMBM<br>* Daily application of NMBM in addition to compression therapy<br>Other: Compression garments<br>* Compression garments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Logarithm of Percentage of Baseline Ulcer Size | 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 | From start of treatment to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alleviation of Pain | 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 | 4 weeks | 
| Incidence of Adverse Events at 4 Weeks | Number of patients with adverse effects at 4 weeks | 4 weeks | 
| Incidence of Adverse Events | Number of adverse effects at 4 weeks | 4 weeks | 
| Time to Complete Closure |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic venous leg ulcers, Venous ulcer, Stasis ulcer, Varicose ulcer