Diabetic Foot Ulcers (DFUs)
Conditions
Brief summary
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.
Interventions
DEVICEBonvadis® (NWBOT)
Bonvadis® (NWBOT) is a topical therapy for wound bed optimization.
DEVICEClostridial Collagenase Ointment
Clostridial Collagenase Ointment is an enzymatic debridement therapy that selectively removes devitalized collagen to support wound bed preparation.
Sponsors
Oneness Biotech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent area reduction (PAR) | 4 weeks after initial treatment |
Countries
United States
Outcome results
None listed