About this trial
This study is designed to evaluate topical wound products for DFUs using a hybrid design that combines prospectively randomized treatment arms with external control cohorts.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged ≥18 years with Type 1 or Type 2 diabetes mellitus.
Presence of at least one diabetic foot ulcer with limited granulation tissue.
Target ulcer located on the foot, predominantly below the malleolus and not on the dorsal toes.
Adequate perfusion of the affected limb as confirmed by vascular assessment.
Disqualifiers
Target ulcer is not diabetic in origin or has exposed tendon or bone.
Clinically significant ulcer-related complications that, in the investigator's judgment, would interfere with study participation or wound assessment.
Use of immunosuppressive, cytotoxic, biologic, or other medications expected to interfere with wound healing.
Recent topical steroid use on the target ulcer.
Trial design
Parallel
Treatments tested in this trial
Bonvadis® (NWBOT)
DeviceBonvadis® (NWBOT) is a topical therapy for wound bed optimization.
Clostridial Collagenase Ointment
DeviceClostridial Collagenase Ointment is an enzymatic debridement therapy that selectively removes devitalized collagen to support wound bed preparation.
Treatment groups
Trial outcomes
Primary outcomes
Percent area reduction (PAR)
Sponsors and contacts
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