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

This study has been completed.
Sponsor:
Information provided by:
Biotec Pharmacon ASA
ClinicalTrials.gov Identifier:
NCT00288392
First received: February 7, 2006
Last updated: October 17, 2006
Last verified: May 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
Foot Ulcer
 Drug: Soluble beta-1,3/1,6-glucan
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biotec Pharmacon ASA:

Primary Outcome Measures:
  • - Time to healing

Secondary Outcome Measures:
  • 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
  • Safety

Estimated Enrollment: 60
Study Start Date: June 2005
Estimated Study Completion Date: September 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288392

Locations
Russian Federation
Municipal Healthcare Institution 1st City Clinical Hospital
Arkhangelsk, Russian Federation, 163061
St. Petersburg State Institution Saint Martyr Elezabeth Hospital
St. Petersburg, Russian Federation, 195257
Sponsors and Collaborators
Biotec Pharmacon ASA
Investigators
Principal Investigator: Tatyana Zykova, Dr.med. Municipal Healthcare Institution 1st City Hospital, Department of Endocrinology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00288392     History of Changes
Other Study ID Numbers: SBG-1-11
Study First Received: February 7, 2006
Last Updated: October 17, 2006
Health Authority: Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Foot Ulcer
Skin Ulcer
 Skin Diseases
Pathologic Processes
Foot Diseases

ClinicalTrials.gov processed this record on May 19, 2013