The present clinical trial is designed to assess the effectiveness of BioChaperone PDGF-BB applied at 4 µg/cm² every other day for up to 20 weeks and associated to Standard of Care as compared to Standard of Care alone for the treatment of neuropathic and neurovascular diabetic foot ulcers.(In order to ensure the double-blinding of the treatments, a sterile normal saline solution presented in the same multi-dose spray vials than BioChaperone PDGF-BB will be applied on patients of the control group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
252
Incidence of complete wound closure.
Time frame: 20 weeks
Time to achieve complete wound closure.
Time frame: 20 weeks
Percentage reduction in total ulcer surface area at each visit.
Time frame: 20 weeks
Incidence of complete wound healing
Time frame: 10 weeks
Number of ulcer recurrence observed 12 weeks after wound healing.
Time frame: 32 weeks
Treatment emergent adverse events.
Time frame: 52 weeks
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Mediciti Hospital
Hyderabad, Andhra Pradesh, India
SL Raheja Hospital
Mumbai, Maharashtra, India
M.V. Hospital for Diabetes (P) Ltd
Chennai, Tamil Nadu, India
Dr V. Seshiah Diabetes Research Institute, Dr Balaji Diabetes Care centre
Chennai, Taminadu, India
B.J. Medical College and Civil Hospital
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Dr Jivraj Mehta Smarak Health Foundation
Ahmedabad, India
Sangini Hospital
Ahmedabad, India
V.S. General Hospital & Sml NHL Municipal Medical College Sheth
Ahmedabad, India
Rajiv Gandhi Centre for Diabetes and Endocrinology
Aligarh, India
Govt Medical College and Hospital
Chandigarh, India
...and 22 more locations