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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
- Beclapermin gel 6.25 µg/cm²/application for 20 weeks.
The assessment schedule for all the three 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, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Diabetic Foot Ulcers
Biochaperone PDGF-BB Low dose, Biochaperone PDGF-BB High dose, Regranex
Vijay Vachharajani Memorial
Not yet recruiting
Published on BioPortfolio: 2014-07-23T21:09:38-0400
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