NCT00632008CompletedPhase 3
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
Biotec Pharmacon ASA11 sites in 1 country122 target enrollmentStarted: March 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 122
- Locations
- 11
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Experimental
SBG
Intervention: Soluble beta-glucan (SBG) (Drug)
2
Placebo Comparator
Intervention: Placebo comparator (Drug)
Investigators
Study Sites (11)
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