PREPUP: A Randomized Trial of Bonvadis® Versus Collagenase Ointment in Diabetic Foot Ulcers
Part of paid clinical trials in North Port, Florida.
- Sponsor
- Oneness Biotech Co., Ltd.
- Study ID
- NCT07779239
- Status
- Not Yet Recruiting
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Conditions
- Diabetic Foot Ulcers (DFUs)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 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.
Study Details
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.
Key Dates
- First listed
- Aug 21, 2026
- Start date
- Aug 31, 2026
- Status verified
- Aug 2026
- Primary completion
- Sep 30, 2026
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Bonvadis® (NWBOT)Eligible subjects will be assigned to receive Bonvadis® (NWBOT) plus Standard of Care.
- Active Comparator: Clostridial Collagenase OintmentEligible subjects will be assigned to receive Clostridial Collagenase Ointment plus Standard of Care.
Primary Outcome Measure
Percent area reduction (PAR) [ Time Frame: 4 weeks after initial treatment ]
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Site #4 | North Port | Florida | 34289 | - |
| Site #3 | Palm Coast | Florida | 32164 | - |
| Site #6 | South Miami | Florida | 33143 | - |
| Site #2 | Metairie | Louisiana | 70001 | - |
| Site #8 | Brooklyn | New York | 11234 | - |
| Site #7 | Akron | Ohio | 44308 | - |
| Site #10 | Circleville | Ohio | 43113 | - |
| Site #9 | Tulsa | Oklahoma | 74135 | - |
| Site #1 | Monroeville | Pennsylvania | 15146 | - |
| Site #5 | Philadelphia | Pennsylvania | 19125 | - |
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- A Real-World Registry of Chronic Wounds and UlcersRecruiting · U.S. Wound Registry · The Woodlands, Texas