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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- - Time to healing
- Number of patients with complete healing of treated ulcers after 12 weeks of treatment
- Percentage reduction in ulcer area of treated ulcers after 12 weeks of treatment
- Percentage weekly reduction in ulcer area in treated ulcers
|Study Start Date:||June 2005|
|Estimated Study Completion Date:||September 2006|
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.
|Municipal Healthcare Institution 1st City Clinical Hospital|
|Arkhangelsk, Russian Federation, 163061|
|St. Petersburg State Institution Saint Martyr Elezabeth Hospital|
|St. Petersburg, Russian Federation, 195257|
|Principal Investigator:||Tatyana Zykova, Dr.med.||Municipal Healthcare Institution 1st City Hospital, Department of Endocrinology|