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

NCT ID: NCT07779239
Registry status: Not yet recruiting
Study type: Not specified in the registry data
Phase: Not applicable
Sponsor: Oneness Biotech Co., Ltd.

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Enrollment: 100 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages: Not specified in the registry data
Sex: Not specified in the registry data
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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.

Study locations

10 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

Florida, United States: 3
Louisiana, United States: 1
New York, United States: 1
Ohio, United States: 2
Oklahoma, United States: 1
Pennsylvania, United States: 2

Sample of listed locations

Site #4 — North Port, Florida, 34289, United States — Site recruitment status not specified in the registry data
Site #3 — Palm Coast, Florida, 32164, United States — Site recruitment status not specified in the registry data
Site #6 — South Miami, Florida, 33143, United States — Site recruitment status not specified in the registry data
Site #2 — Metairie, Louisiana, 70001, United States — Site recruitment status not specified in the registry data
Site #8 — Brooklyn, New York, 11234, United States — Site recruitment status not specified in the registry data
Site #7 — Akron, Ohio, 44308, United States — Site recruitment status not specified in the registry data
Site #10 — Circleville, Ohio, 43113, United States — Site recruitment status not specified in the registry data
Site #9 — Tulsa, Oklahoma, 74135, United States — Site recruitment status not specified in the registry data
Site #1 — Monroeville, Pennsylvania, 15146, United States — Site recruitment status not specified in the registry data
Site #5 — Philadelphia, Pennsylvania, 19125, United States — Site recruitment status not specified in the registry data

Study details

Start date: August 1, 2026
Primary completion date: September 1, 2026
First posted: August 21, 2026

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07779239
Registry last updated: August 21, 2026
QualifiedStudies registry data refreshed: September 21, 2026

View NCT07779239 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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