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

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biotec Pharmacon ASA

Criteria

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