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