Chronic foot ulcers in diabetes
Conditions
Interventions
Product Name: Soluble beta-1,3/1,6-glucan
Product Code: SBG
Pharmaceutical Form: Cutaneous solution
CAS Number: 53238-80-5
Current Spons
Sponsors
Biotec Pharmacon ASA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Type 1 or type 2 diabetes mellitus - Age 18 years or more - 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) must have been present for at least 4 weeks but not longer than 2 years - Adequate circulation to the foot (ABPI >0.7 or presence of two palpable pulses on the affected foot - Ulcer area >25 mm2 but =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 - Chronic renal failure with calculated GFR <30 ml/min - Surgical procedure (other than debridement) on the foot with the study ulcer in the last 28 days - HbA1c 12% or more - Current alcohol or drug abuse - Participation in other studies in the preceding 28 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of topically administered soluble beta-1,3/1,6-glucan (SBG) compared with that of placebo in chronic foot ulcers in diabetes.; Secondary Objective: - The time to healing of index ulcers which heal within 8 weeks - The change in ulcer area in treated ulcers - The safety of SBG by comparing safety parameters - Patient well-being and satisfaction - Breakdown of healed ulcers within 12 weeks ;Primary end point(s): The number of index ulcers which heal by 8 weeks. | — |
Countries
United Kingdom
Outcome results
None listed