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

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.

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