Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Oneness Biotech Co., Ltd.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | PREPUP: A Randomized Trial of Bonvadis® Versus Collagenase Ointment in Diabetic Foot Ulcers
