What this study is
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.
What's being tested
- Bonvadis® (NWBOT)
Intervention · DEVICE
Bonvadis® (NWBOT) is a topical therapy for wound bed optimization.
- Clostridial Collagenase Ointment
Intervention · DEVICE
Clostridial Collagenase Ointment is an enzymatic debridement therapy that selectively removes devitalized collagen to support wound bed preparation.
Study details
- Official title
- A Prospective, Multicenter, Multi-Product, Comparative Effectiveness, Randomized Controlled Clinical Trial Evaluating a Novel Wound Bed Optimization Technology (NWBOT) and Standard of Care (SOC) Versus Clostridial Collagenase Ointment (CCO) Plus SOC in Diabetic Foot Ulcers, With Matched-Control Comparison to Topical Hydrogel and Comparisons to Synthetic Standard-of-Care and Topical Collagen Comparator Cohorts.
- Sponsor
- Oneness Biotech Co., Ltd.
- Conditions
- Diabetic Foot Ulcers (DFUs)
- Enrolling
- 100 people
- Starts
- 2026-08
- Est. completion
- 2027-09
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (10)
10 openSite #4
North Port, Florida, United States
Site #3
Palm Coast, Florida, United States
Site #6
South Miami, Florida, United States
Site #2
Metairie, Louisiana, United States
Site #8
Brooklyn, New York, United States
Site #7
Akron, Ohio, United States
Site #10
Circleville, Ohio, United States
Site #9
Tulsa, Oklahoma, United States
Site #1
Monroeville, Pennsylvania, United States
Site #5
Philadelphia, Pennsylvania, United States
Study team
Sponsor
Oneness Biotech Co., Ltd.
Study ID Pro04051910
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.