Status:
COMPLETED
Soluble Beta-glucan (SBG) as Treatment for Diabetic Foot Ulcers
Lead Sponsor:
Biotec Pharmacon ASA
Conditions:
Chronic Diabetic Foot Ulcers
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00632008
Start Date
March 1 2007
End Date
October 1 2009
Last Update
January 26 2010
Active Locations (11)
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1
Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
2
Royal Blackburn Hospital
Blackburn, United Kingdom, BB2 3LR
3
Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
4
Southmead Hospital
Bristol, United Kingdom, BS10 5NB