Clinical trial NCT01770509: The Effect of the Cosmetic Cream NMBM on Leg Ulcers - a Pilot Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ulcer
Venous Ulcer
Skin Ulcer
Leg Ulcer
Keywords: Chronic venous leg ulcers
Venous ulcer
Stasis ulcer
Varicose ulcer
Lead sponsor: M.D. Lederman Consulting Ltd
Sponsor class: INDUSTRY
First posted: 2013-01-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

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.

Primary outcomes:
measure: Logarithm of Percentage of Baseline Ulcer Size
timeFrame: From start of treatment to 4 weeks
Secondary outcomes:
measure: Alleviation of Pain
timeFrame: 4 weeks
measure: Incidence of Adverse Events at 4 Weeks
timeFrame: 4 weeks
measure: Incidence of Adverse Events
timeFrame: 4 weeks
measure: Time to Complete Closure
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: The Department of Dermatology, Sheba Medical Center
Study officials:
affiliation: The Department of Dermatology, Sheba Medical Center
name: Shoshana Greenberger, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: