CompletedPhase 1/2

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

Israel30 participantsStarted 2013-02

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

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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

What they're measuring

Logarithm of Percentage of Baseline Ulcer Size

Timeframe: From start of treatment to 4 weeks

Trial details

NCT IDNCT01770509

SponsorM.D. Lederman Consulting Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-02

Results submitted2015-05-17

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