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PREPUP: A Randomized Trial of Bonvadis® Versus Collagenase Ointment in Diabetic Foot Ulcers
Sponsor: 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.
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-08
Completion Date
2027-09
Last Updated
2026-08-21
Healthy Volunteers
No
Conditions
Interventions
Bonvadis® (NWBOT)
Bonvadis® (NWBOT) is a topical therapy for wound bed optimization.
Clostridial Collagenase Ointment
Clostridial Collagenase Ointment is an enzymatic debridement therapy that selectively removes devitalized collagen to support wound bed preparation.
Locations (10)
Site #4
North Port, Florida, United States
Site #3
Palm Coast, Florida, United States
Site #6
South Miami, Florida, United States
Site #2
Metairie, Louisiana, United States
Site #8
Brooklyn, New York, United States
Site #7
Akron, Ohio, United States
Site #10
Circleville, Ohio, United States
Site #9
Tulsa, Oklahoma, United States
Site #1
Monroeville, Pennsylvania, United States
Site #5
Philadelphia, Pennsylvania, United States