Diabetic Foot Ulcers Clinical Trial
Official title:
A Phase I/II, Multicentre, Randomised, Controlled, and Open-label Trial Comparing the Efficacy and Safety of Three Dose Regimens of BioChaperone PDGF-BB to Becaplermin Gel for the Treatment of Diabetic Foot Ulcer
This is an open-label, active-control, multicentre, parallel group, randomised and
dose-finding efficacy and safety study.
Compare the efficacy and safety of BioChaperone PDGF-BB applied at 12.5 µg/cm² every two
days for up to 20 weeks to becaplermin gel (Regranex® Gel 0.01%) applied daily for up to 20
weeks for the treatment of neuropathic diabetic foot ulcer.
Assess the effect of a double dose of BioChaperone PDGF-BB (25 µg/cm²) applied every two
days for up to 20 weeks.
After the screening visit, the eligible patient population randomly receive one of the three
following topical drugs:
- BioChaperone™ PDGF-BB 12.5 µg/cm²/application for 20 weeks,
- BioChaperone™ PDGF-BB 25 µg/cm²/application for 20 weeks, or
- BioChaperone™ PDGF-BB 4 µg/cm²/application for 20 weeks, or
- Beclapermin gel 6.25 µg/cm²/application for 20 weeks.
The assessment schedule for all the four groups is weekly once (7 day duration) till the 8th
week (visit 10) and once in two weeks (14 day duration) thereafter till the end of study.
The maximum number of visits expected is 16. The study data is presented at the end of 20
weeks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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