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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Logarithm of Percentage of Baseline Ulcer Size
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
- •Suffers from clinically significant arterial disease
- •Has a known allergy to any of the compounds that are part of this protocol
- •Has evidence of the ulcer and / or infection extending to the underlying muscle, tendon or bone
- •Has used any investigational drug(s) within 30 days preceding randomization
- •Is unable to manage self-treatment
- •Is pregnant, nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinence)
- •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
- •Unwilling or unable to comply with study requirements.
Outcomes
Primary Outcomes
Logarithm of Percentage of Baseline Ulcer Size
Time Frame: 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 Outcomes
- Incidence of Adverse Events(4 weeks)
- Incidence of Adverse Events at 4 Weeks(4 weeks)
- Alleviation of Pain(4 weeks)
- Time to Complete Closure(4 weeks)