Status:
COMPLETED
Efficacy of Soluble Beta-1,3/1,6-Glucan Compared to Placebo on Chronic Leg Ulcers in Diabetes Patients
Lead Sponsor:
Biotec Pharmacon ASA
Conditions:
Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
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 ulce...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00288392
Start Date
June 1 2005
End Date
September 1 2006
Last Update
October 18 2006
Active Locations (2)
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1
Municipal Healthcare Institution 1st City Clinical Hospital
Arkhangelsk, Russia, 163061
2
St. Petersburg State Institution Saint Martyr Elezabeth Hospital
Saint Petersburg, Russia, 195257