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

Foot Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00288392
• Other study ID #: SBG-1-11
• Status: Completed
• Phase: Phase 2
• First received: February 7, 2006
• Last updated: October 17, 2006
• Start date: June 2005
• Est. completion date: September 2006

Study information

• Verified date: May 2006
• Source: Biotec Pharmacon ASA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Foot Ulcer
• Ulcer

Intervention

Drug:
• Soluble beta-1,3/1,6-glucan

Locations

Country	Name	City	State
Russian Federation	Municipal Healthcare Institution 1st City Clinical Hospital	Arkhangelsk
Russian Federation	St. Petersburg State Institution Saint Martyr Elezabeth Hospital	St. Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Biotec Pharmacon ASA

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Time to healing
Secondary	Number of patients with complete healing of treated ulcers after 12 weeks of treatment
Secondary	Percentage reduction in ulcer area of treated ulcers after 12 weeks of treatment
Secondary	Percentage weekly reduction in ulcer area in treated ulcers
Secondary	Safety