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

Inclusion criteria

• 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.
• If multiple eligible ulcers are present, the largest qualifying ulcer will be designated as the target ulcer.
• Willing to comply with the prescribed offloading method and required weekly study visits.
• Willing and able to provide informed consent and comply with study procedures.

Exclusion criteria

• 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.
• Prior partial amputation, foot deformity, or other foot condition that prevents adequate offloading of the target ulcer.
• Pregnancy, planned pregnancy during the study period, or another significant medical condition requiring ongoing supportive treatment.
• Participation in another interventional clinical trial involving an investigational product within the previous 30 days.
• 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.