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
Qualifiers
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
Treatments tested in this trial
- Bonvadis® (NWBOT)
- Clostridial Collagenase Ointment