Efficacy of Soluble Beta-1,3/1,6-Glucan Compared to Placebo on Chronic Leg Ulcers in Diabetes Patients
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|ClinicalTrials.gov Identifier: NCT00288392|
Recruitment Status : Completed
First Posted : February 8, 2006
Last Update Posted : October 18, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|Foot Ulcer||Drug: Soluble beta-1,3/1,6-glucan||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||June 2005|
|Estimated Study Completion Date :||September 2006|
- - 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288392
|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|