Soluble Beta-glucan (SBG) as Treatment for Diabetic Foot Ulcers

January 25, 2010 updated by: Biotec Pharmacon ASA

A Randomised, Double-blind, Placebo-controlled Study to Determine the Efficacy of Soluble Beta-1,3/1,6-glucan in Chronic Foot Ulcers in Diabetes

The purpose of this study is to determine whether the application of soluble beta-glucan (SBG) onto diabetic foot ulcers improves the healing of the ulcers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 3

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

  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Belfast City Hospital
      • Blackburn, United Kingdom, BB2 3LR
        • Royal Blackburn Hospital
      • Bournemouth, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
      • Bristol, United Kingdom, BS10 5NB
        • Southmead Hospital
      • Glasgow, United Kingdom, G42 9TY
        • NHS Greater Glasgow and Clyde Victoria
      • Leeds, United Kingdom, LS1 3EX
        • Leeds General Infirmary
      • Leicester, United Kingdom, LE5 4PW
        • Leicester General Hospital
      • Manchester, United Kingdom, M8 5RB
        • North Manchester Hospital
      • Newcastle, United Kingdom, NE1 4LP
        • Newcastle General Hospital
      • Northampton, United Kingdom, NN1 5BD
        • Northampton General Hospital
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City 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
  • One or more full-thickness ulcers at or below the level of the malleoli, which do not extend to tendon, joint, or bone
  • The ulcer (or index ulcer, if appropriate) must have been present for at least 4 weeks prior to Day 0 but not longer than 2 years
  • Ankle:brachial pressure index (ABPI) >0.7, or the presence of two palpable pulses on the affected foot
  • Ulcer area >25 mm2 but <500 mm2
  • Written informed consent

Exclusion Criteria:

  • Pregnancy, lactation or absence of adequate contraception for women with child bearing capacity
  • ABPI < 0.7
  • Serum albumin < 2.0 g/dL
  • Gangrene on any part of the foot with the study ulcer
  • Presence of signs of clinically significant foot infection on Day 0
  • Chronic renal failure with calculated GFR <30 ml/min
  • Surgical procedure (other than debridement) on the foot with the study ulcer in the 28 days prior to Day 0
  • HbA1c 12% or more
  • Current alcohol or drug abuse
  • Participation in other studies in the preceding 28 days
  • An ulcer on a foot affected by acute Charcot osteoarthropathy

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: Placebo comparator
Topical application of placebo to wound, at least twice a week until compleate healing or for maximum 8 weeks.
Experimental: 1
SBG
Drug: Soluble beta-glucan (SBG)
Topical application of SBG to the wound, at least twice a week until complete healing or for 8 maximum weeks

Collaborators and Investigators

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

Sponsor

Biotec Pharmacon ASA

Investigators

  • Principal Investigator: William Jeffcoate, MD, PhD, Nottingham City Hospital

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

March 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

February 29, 2008

First Submitted That Met QC Criteria

February 29, 2008

First Posted (Estimate)

March 10, 2008

Study Record Updates

Last Update Posted (Estimate)

January 26, 2010

Last Update Submitted That Met QC Criteria

January 25, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBG-1-12

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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