A Prospective, Multicenter, Multi-Product, Comparative Effectiveness, Randomized Controlled Clinical Trial Evaluating a Novel Wound Bed Optimization Technology (NWBOT) and Standard of Care (SOC) Versus Clostridial Collagenase Ointment (CCO) Plus SOC in Diabetic Foot Ulcers, With Matched-Control Comparison to Topical Hydrogel and Comparisons to Synthetic Standard-of-Care and Topical Collagen Comparator Cohorts.

Oneness Biotech Co., Ltd.

Summary

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

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Adults aged ≥18 years with Type 1 or Type 2 diabetes mellitus. 2. Presence of at least one diabetic foot ulcer with limited granulation tissue. 3. Target ulcer located on the foot, predominantly below the malleolus and not on the dorsal toes. 4. Adequate perfusion of the affected limb as confirmed by vascular assessment. 5. If multiple eligible ulcers are present, the largest qualifying ulcer will be designated as the target ulcer. 6. Willing to comply with the prescribed offloading method and required weekly study visits. 7. Willing and able to provide informed consent…

Interventions

Device
Bonvadis® (NWBOT)
Bonvadis® (NWBOT) is a topical therapy for wound bed optimization.
Device
Clostridial Collagenase Ointment
Clostridial Collagenase Ointment is an enzymatic debridement therapy that selectively removes devitalized collagen to support wound bed preparation.

Summary

Eligibility

Interventions

Locations (10)