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Clinical Trials in the USA / NCT07779239
Starting soon Not applicable

PREPUP: A Randomized Trial of Bonvadis® Versus Collagenase Ointment in Diabetic Foot Ulcers

NCT07779239 · tracked via the Priya Life Science USA tracker
Sponsor
Oneness Biotech Co., Ltd.
Phase
Not applicable
Started
2026-08
Last updated
2026-08-21

Condition(s) studied

Diabetic Foot Ulcers (DFUs)

Investigational drug(s) / intervention(s)

Bonvadis® (NWBOT)Clostridial Collagenase Ointment

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 and comply with study procedures. Exclusion Criteria: 1. Target ulcer is not diabetic in origin or has exposed tendon or bone. 2. Clinically significant ulcer-related complications that, in the investigator's judgment, would interfere with study participation or wound assessment. 3. Use of immunosuppressive, cytotoxic, biologic, or other medications expected to interfere with wound healing. 4. Recent topical steroid use on the target ulcer. 5. Prior partial amputation, foot deformity, or other foot condition that prevents adequate offloading of the target ulcer. 6. Pregnancy, planned pregnancy during the study period, or another significant medical condition requiring ongoing supportive treatment. 7. Participation in another interventional clinical trial involving an investigational product within the previous 30 days. 8. 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.

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
Site #4 North Port Florida
Site #3 Palm Coast Florida
Site #6 South Miami Florida
Site #2 Metairie Louisiana
Site #8 Brooklyn New York
Site #7 Akron Ohio
Site #10 Circleville Ohio
Site #9 Tulsa Oklahoma
Site #1 Monroeville Pennsylvania
Site #5 Philadelphia Pennsylvania

More Oneness Biotech Co., Ltd. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07779239 on ClinicalTrials.gov ↗ ← All trials in the USA