Leg Ulcer Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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