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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOneness Biotech Co., Ltd.

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Bonvadis® (NWBOT)
  • Clostridial Collagenase Ointment

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators