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Diabetic Foot Ulcers (DFUs)SkinMetabolicDevice

What this study is

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.

What's being tested

  • Bonvadis® (NWBOT)

    Intervention · DEVICE

    Bonvadis® (NWBOT) is a topical therapy for wound bed optimization.

  • Clostridial Collagenase Ointment

    Intervention · DEVICE

    Clostridial Collagenase Ointment is an enzymatic debridement therapy that selectively removes devitalized collagen to support wound bed preparation.

Study details

Official title
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.
Sponsor
Oneness Biotech Co., Ltd.
Conditions
Diabetic Foot Ulcers (DFUs)
Enrolling
100 people
Starts
2026-08
Est. completion
2027-09
Design
Open-label, randomized, parallel groups
Record
View on ClinicalTrials.gov ↗