ISRCTN11013503
Completed
未知
An open-label, multicentre, clinical investigation of the safety and performance of a new collagen-based, chondroitin sulfate- and chitosan-containing active wound care dressing, associated to standard of care, in the treatment of chronic, non-ischemic, non-healing diabetic foot ulcer
IBSA Institut Biochimique S.A0 sites40 target enrollmentMay 4, 2022
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Chronic, non-ischemic, non-healing diabetic foot ulcer (DFU)
- Sponsor
- IBSA Institut Biochimique S.A
- Enrollment
- 40
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adult male and female outpatients aged \=18 years
- •2\. Subject being diagnosed with type 1 or type 2 diabetes
- •3\. Subject diagnosed with plantar neuropathic DFU (positive Semmes\-Weinstein 10 g Monofilament test)
- •4\. Chronic DFU present from \=4 weeks and \= 24 weeks
- •5\. DFU cross\-sectional area of \=1 cm² and \=10 cm²
- •6\. DFU of grade 1A\-1B or 2A\-2B according to the University of Texas Staging System for Diabetic Foot Ulcers
- •7\. DFU Grade 1/uninfected or Grade 2/mild infected according to Infectious Diseases Society of America (IDSA) classification
- •8\. Glycated haemoglobin HbA1c value \=9% at Screening or within 3 months prior to inclusion
- •9\. Presence of dorsalis and posterior tibial pulses and Ankle\-Brachial Pressure Index (ABPI) value \=0\.9 and \=1\.2 at Screening or within 3 months prior to inclusion
- •10\. No surgery at the limb of interest within 1 month prior to inclusion
Exclusion Criteria
- •1\. DFU of ischemic or neuroischemic origin (ABPI \<0\.9\)
- •2\. DFU which cross\-sectional area diminished \>30% during the 2\-week run\-in period of the study, i.e. between V1 and V2
- •3\. Infected DFU at the end of the run\-in period, i.e. V2
- •4\. Superinfected DFU (Grade 3\-4 according to IDSA classification) including osteitis
- •5\. Presence of necrotic tissue on the target DFU bed
- •6\. DFU with exposed tendon or bone
- •7\. Active Charcot’s foot
- •8\. Presence of more than one plantar DFU in the limb of interest
- •9\. Presence of plantar DFUs in both limbs
- •Treatment\-specific exclusion criteria:
Outcomes
Primary Outcomes
Not specified
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