Chronic Diabetic Foot Ulcers
Conditions
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.
Interventions
Topical application of SBG to the wound, at least twice a week until complete healing or for 8 maximum weeks
DRUGPlacebo comparator
Topical application of placebo to wound, at least twice a week until compleate healing or for maximum 8 weeks.
Sponsors
Biotec Pharmacon ASA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Countries
United Kingdom
Outcome results
None listed