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

Chronic Diabetic Foot Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00632008
• Other study ID #: SBG-1-12
• Status: Completed
• Phase: Phase 3
• First received: February 29, 2008
• Last updated: January 25, 2010
• Start date: March 2007
• Est. completion date: October 2009

Study information

• Verified date: January 2010
• Source: Biotec Pharmacon ASA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Health care products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: October 2009
• Est. primary completion date: August 2009
• 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

• 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Diabetic Foot Ulcers
• Diabetic Foot
• Foot Ulcer
• Ulcer

Intervention

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
• Placebo comparator
Topical application of placebo to wound, at least twice a week until compleate healing or for maximum 8 weeks.

Locations

Country	Name	City	State
United Kingdom	Belfast City Hospital	Belfast
United Kingdom	Royal Blackburn Hospital	Blackburn
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	Southmead Hospital	Bristol
United Kingdom	NHS Greater Glasgow and Clyde Victoria	Glasgow
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	Leicester General Hospital	Leicester
United Kingdom	North Manchester Hospital	Manchester
United Kingdom	Newcastle General Hospital	Newcastle
United Kingdom	Northampton General Hospital	Northampton
United Kingdom	Nottingham City Hospital	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Biotec Pharmacon ASA

Country where clinical trial is conducted

United Kingdom,