Efficacy of Soluble Beta-1,3/1,6-Glucan Compared to Placebo on Chronic Leg Ulcers in Diabetes Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Foot Ulcer

Intervention / Treatment
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* Drug: Soluble beta-1,3/1,6-glucan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 or Type 2 diabetes mellitus Age>= 18 years Study wound is a Wagner Grade 1 partial thickness or Grade 2 full thickness lesion but without exposed tendon, joint, or bones Study wound located on the foot or lower leg Study wound must have been present for at least 4 weeks prior to Day 0 but not longer than 2 years Adequate circulation to the foot, evidenced by a palpable pulse on the study foot Study wound > 1.0cm2 but < 20.0cm2 Written informed consent Exclusion Criteria: Pregnancy, lactation or absence of adequate contraception for fertile women Ankle/Brachial Index < 0.7 Severe malnutrition Clinical evidence of gangrene on any part of the foot with the study wound Active or extensive cellulitis extending more than 1 cm beyond wound margin and/or presence of cellulitis with purulent discharge on day 0 One or more medical condition(s) that in the opinion of the investigator would make the patient an inappropriate candidate for the study Active osteomyelitis of the foot with the study wound Necrotic toes on the foot with the study wound Surgical procedure (other than debridement) on the foot with the study wound the last 21 days prior to screening Study wound over a Charcot's joint Evidence of deep tissue infection of the study wound at day 0 Non-study wound on the study foot that is located within 5.0cm from the study wound at day 0 Random blood sugar reading > 450 mg/dL Alcohol or drug abuse Participation in other clinical studies in the last 4 weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Soluble beta-1,3/1,6-glucan|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Time to healing |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 
| Safety |  |  |