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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
192
BioChaperone PDGF-BB low dose is applied as a spray every two days at the dose of 12.5 µg/cm2 for up to 20 weeks
BioChaperone PDGF-BB high dose is applied as a spray every two days at the dose of 25 µg/cm2 for up to 20 weeks
Regranex gel is applied once daily at the dose of 6.25 µg/cm2 for up to 20 weeks
Vijay Vachharajani Memorial
Rajkot, Gujarat, India
Jain Institute of Vascular sciences
Bangalore, Karnataka, India
Karnataka Institute of Diabetology
Bangalore, Karnataka, India
Lakeshore Hospital & Research Centre Ltd
Kochi, Kerala, India
Incidence of complete wound closure
Incidence of complete wound closure
Time frame: 20 WEEKS
Time to achieve complete wound closure
Time to achieve complete wound closure
Time frame: Study duration 20 weeks
Percentage reduction in total ulcer surface area at each visit.
Time frame: Study duration 20 weeks
Incidence of complete wound healing at week 10
Time frame: 10 weeks
Safety Safety Measures
1. Treatment emergent adverse events with investigator's assessment of seriousness, severity, duration and relationship to study medication 2. Wound-related infections 3. Changes in standard laboratory tests (hematology, biochemistry and detection of antibodies)
Time frame: Study duration 20 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
BioChaperone PDGF-BB Very Low Dose sprayed on the wound every two days (e.g., Mondays, Wednesdays and Fridays) for 20 weeks or until complete wound healing, at the dose of 4 µg/cm²/application
Joshi Hospital , Maharashra Medical Foundation
Pune, Maharashtra, India
M.V. Hospital for Diabetes
Chennai, Tamil Nadu, India
S.K. Diabetes Research & Education Centre
Kolkata, West Bengal, India