PREPUP: A Randomized Trial of Bonvadis® Versus Collagenase Ointment in Diabetic Foot Ulcers
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.
1 other identifier
interventional
100
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2026
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2026
CompletedFirst Submitted
Initial submission to the registry
August 19, 2026
CompletedFirst Posted
Study publicly available on registry
August 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
August 21, 2026
August 1, 2026
1 month
August 19, 2026
August 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percent area reduction (PAR)
4 weeks after initial treatment
Study Arms (2)
Bonvadis® (NWBOT)
EXPERIMENTALEligible subjects will be assigned to receive Bonvadis® (NWBOT) plus Standard of Care.
Clostridial Collagenase Ointment
ACTIVE COMPARATOREligible subjects will be assigned to receive Clostridial Collagenase Ointment plus Standard of Care.
Interventions
Bonvadis® (NWBOT) is a topical therapy for wound bed optimization.
Clostridial Collagenase Ointment is an enzymatic debridement therapy that selectively removes devitalized collagen to support wound bed preparation.
Eligibility Criteria
You may qualify if:
- 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.
- If multiple eligible ulcers are present, the largest qualifying ulcer will be designated as the target ulcer.
- Willing to comply with the prescribed offloading method and required weekly study visits.
- Willing and able to provide informed consent and comply with study procedures.
You may not qualify if:
- 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.
- Prior partial amputation, foot deformity, or other foot condition that prevents adequate offloading of the target ulcer.
- Pregnancy, planned pregnancy during the study period, or another significant medical condition requiring ongoing supportive treatment.
- Participation in another interventional clinical trial involving an investigational product within the previous 30 days.
- Any medical, psychological, nutritional, or hypersensitivity condition that, in the investigator's judgment, may interfere with study participation, assessments, or treatment, including malnutrition or known/suspected hypersensitivity to collagenase or Bonvadis/NWBOT ingredients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Site #4
North Port, Florida, 34289, United States
Site #3
Palm Coast, Florida, 32164, United States
Site #6
South Miami, Florida, 33143, United States
Site #2
Metairie, Louisiana, 70001, United States
Site #8
Brooklyn, New York, 11234, United States
Site #7
Akron, Ohio, 44308, United States
Site #10
Circleville, Ohio, 43113, United States
Site #9
Tulsa, Oklahoma, 74135, United States
Site #1
Monroeville, Pennsylvania, 15146, United States
Site #5
Philadelphia, Pennsylvania, 19125, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2026
First Posted
August 21, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2027
Last Updated
August 21, 2026
Record last verified: 2026-08