Soluble Beta-glucan (SBG) as Treatment for Diabetic Foot Ulcers
Phase 3
Completed
- Conditions
- Chronic Diabetic Foot Ulcers
- Interventions
- Drug: Soluble beta-glucan (SBG)Drug: Placebo comparator
- Registration Number
- NCT00632008
- Lead Sponsor
- Biotec Pharmacon ASA
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Soluble beta-glucan (SBG) SBG 2 Placebo comparator -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
North Manchester Hospital
🇬🇧Manchester, United Kingdom
Belfast City Hospital
🇬🇧Belfast, United Kingdom
NHS Greater Glasgow and Clyde Victoria
🇬🇧Glasgow, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
Royal Blackburn Hospital
🇬🇧Blackburn, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
Southmead Hospital
🇬🇧Bristol, United Kingdom
Leicester General Hospital
🇬🇧Leicester, United Kingdom
Northampton General Hospital
🇬🇧Northampton, United Kingdom
Newcastle General Hospital
🇬🇧Newcastle, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom