Foot Ulcer Clinical Trial
Official title:
A Double-Blind Therapeutic Exploratory Clinical Study to Evaluate the Efficacy of Soluble Beta-1,3/1,6-Glucan Compared to Placebo on Chronic Leg Ulcers in Diabetes Patients
The purpose of this study is to evaluate the efficacy of soluble beta-1,3/1,6-glucan
compared to placebo on the healing of chronic leg ulcers in diabetes patients.
Hypothesis: Through its ability to activate tissue macrophages and counteract
diabetes-associated defects in macrophages, the soluble beta-1,3/1,6-glucan will promote the
healing of leg ulcers in diabetic patients.
Diabetes predisposes to ulceration of the foot through a variety of processes, including
neuropathy and peripheral arterial disease. Once the skin is broken, healing is frequently
delayed and the ulcer develops the biology of a chronic wound. The factors underlaying
delayed healing in chronic wounds are not well understood but include the effects of
repeated trauma, tissue ischemia, infection, defective white cell function, altered immune
processes, and altered expression of tissue cytokines and enzymes.
Management is based on regular cleansing and debridement, off-loading and treatment of
intercurrent infection with antibiotics. There are no interventions in routine use, which
target aspects of chronic wound biology directly.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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