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Completed

NCT Number: NCT00632008

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

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.

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Key information

Conditions

Chronic Diabetic Foot Ulcers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Belfast City Hospital, Belfast, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Soluble beta-glucan (SBG)

Drug

Topical application of SBG to the wound, at least twice a week until complete healing or for 8 maximum weeks

placebo comparator

Drug

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

Sponsors and collaborators

Lead sponsor

Biotec Pharmacon ASA

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 10, 2008
Registry last updated
Jan 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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