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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biotec Pharmacon ASA

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