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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00632008
First Posted: March 10, 2008
Last Update Posted: January 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Biotec Pharmacon ASA
  Purpose
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.

Condition Intervention Phase
Chronic Diabetic Foot Ulcers Drug: Soluble beta-glucan (SBG) Drug: Placebo comparator Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Biotec Pharmacon ASA:

Enrollment: 122
Study Start Date: March 2007
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632008


Locations
United Kingdom
Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
Royal Blackburn Hospital
Blackburn, United Kingdom, BB2 3LR
Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
Southmead Hospital
Bristol, United Kingdom, BS10 5NB
NHS Greater Glasgow and Clyde Victoria
Glasgow, United Kingdom, G42 9TY
Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
Leicester General Hospital
Leicester, United Kingdom, LE5 4PW
North Manchester Hospital
Manchester, United Kingdom, M8 5RB
Newcastle General Hospital
Newcastle, United Kingdom, NE1 4LP
Northampton General Hospital
Northampton, United Kingdom, NN1 5BD
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
Biotec Pharmacon ASA
Investigators
Principal Investigator: William Jeffcoate, MD, PhD Nottingham City Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00632008     History of Changes
Other Study ID Numbers: SBG-1-12
First Submitted: February 29, 2008
First Posted: March 10, 2008
Last Update Posted: January 26, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases