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

Not Yet RecruitingNA

Sponsor: Oneness Biotech Co., Ltd.

Conditions: Diabetic Foot Ulcers (DFUs)

Interventions: Bonvadis® (NWBOT), Clostridial Collagenase Ointment

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (10)

North Port, Florida, United States
Palm Coast, Florida, United States
South Miami, Florida, United States
Metairie, Louisiana, United States
Brooklyn, New York, United States
Akron, Ohio, United States
Circleville, Ohio, United States
Tulsa, Oklahoma, United States
Monroeville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States