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

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