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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Bonvadis® (NWBOT)

    Device

    Bonvadis® (NWBOT) is a topical therapy for wound bed optimization.

  • Clostridial Collagenase Ointment

    Device

    Clostridial Collagenase Ointment is an enzymatic debridement therapy that selectively removes devitalized collagen to support wound bed preparation.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Bonvadis® (NWBOT)Experimental treatment 1 intervention
Group B: Clostridial Collagenase OintmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent area reduction (PAR)

Time frame
4 weeks after initial treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: