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

October 17, 2006 updated by: Biotec Pharmacon ASA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Arkhangelsk, Russian Federation, 163061
        • Municipal Healthcare Institution 1st City Clinical Hospital
      • St. Petersburg, Russian Federation, 195257
        • St. Petersburg State Institution Saint Martyr Elezabeth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
- Time to healing

Secondary Outcome Measures

Outcome Measure
Safety
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotec Pharmacon ASA

Investigators

  • Principal Investigator: Tatyana Zykova, Dr.med., Municipal Healthcare Institution 1st City Hospital, Department of Endocrinology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion

September 1, 2006

Study Registration Dates

First Submitted

February 7, 2006

First Submitted That Met QC Criteria

February 7, 2006

First Posted (Estimate)

February 8, 2006

Study Record Updates

Last Update Posted (Estimate)

October 18, 2006

Last Update Submitted That Met QC Criteria

October 17, 2006

Last Verified

May 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBG-1-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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