Phase 2
N=29
The Effect of the Cosmetic Cream NMBM on Leg Ulcers - a Pilot Study
Ulcer · Venous Ulcer · Skin Ulcer · Leg Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT01770509 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Logarithm of Percentage of Baseline Ulcer Size — 3.6043; 3.5030 Mean of log (percentage of baseline area — p=0.652
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NMBM (Device); Compression garments (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Lederman Consulting Ltd
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Logarithm of Percentage of Baseline Ulcer Size |
3.6043; 3.5030 | 0.652 |
| SECONDARY Alleviation of Pain |
2.45; 1.68 | 0.645 |
| SECONDARY Incidence of Adverse Events at 4 Weeks |
1; 3 | — |
| SECONDARY Incidence of Adverse Events |
1; 3 | — |
| SECONDARY Time to Complete Closure |
— | — |
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.
Eligibility Criteria
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. 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.
Data sourced from ClinicalTrials.gov (NCT01770509). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.