Diabetic Foot Ulcers (DFUs)NCT07779239
PREPUP: A Randomized Trial of Bonvadis® Versus Collagenase Ointment in Diabetic Foot Ulcers
A study testing Bonvadis® (NWBOT) and Clostridial Collagenase Ointment in people with Diabetic Foot Ulcers (DFUs), run by Oneness Biotech Co., Ltd. at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers (DFUs)
- What is being tested?
- Bonvadis® (NWBOT) and Clostridial Collagenase Ointment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 10 sitesUnited States
- Study dates
- Aug 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites
Site #7
Akron, Ohio, 44308
Site #8
Brooklyn, New York, 11234
Site #10
Circleville, Ohio, 43113
Site #2
Metairie, Louisiana, 70001
Site #1
Monroeville, Pennsylvania, 15146
Site #4
North Port, Florida, 34289
Site #3
Palm Coast, Florida, 32164
Site #5
Philadelphia, Pennsylvania, 19125
Site #6
South Miami, Florida, 33143
Site #9
Tulsa, Oklahoma, 74135
About this study
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.
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.
- Conditions
- Diabetic Foot Ulcers (DFUs)
- Being tested
- Bonvadis® (NWBOT), Clostridial Collagenase Ointment
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bonvadis® (NWBOT)Device
Bonvadis® (NWBOT) is a topical therapy for wound bed optimization.
Clostridial Collagenase OintmentDevice
Clostridial Collagenase Ointment is an enzymatic debridement therapy that selectively removes devitalized collagen to support wound bed preparation.
| Study group | Role | What they receive |
|---|---|---|
| Bonvadis® (NWBOT) | Experimental | Eligible subjects will be assigned to receive Bonvadis® (NWBOT) plus Standard of Care. Receives: Device: Bonvadis® (NWBOT) |
| Clostridial Collagenase Ointment | Active comparator | Eligible subjects will be assigned to receive Clostridial Collagenase Ointment plus Standard of Care. Receives: Device: Clostridial Collagenase Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent area reduction (PAR)
Measured: 4 weeks after initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcers (DFUs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oneness Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779239
- Sponsor's protocol ID
- Pro04051910
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07779239
- Acronym / sponsor ID
- Pro04051910
- Conditions
- Diabetic Foot Ulcers (DFUs)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Oneness Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bonvadis® (NWBOT) | Experimental | Device: Bonvadis® (NWBOT)Eligible subjects will be assigned to receive Bonvadis® (NWBOT) plus Standard of Care. |
| Clostridial Collagenase Ointment | Active comparator | Device: Clostridial Collagenase OintmentEligible subjects will be assigned to receive Clostridial Collagenase Ointment plus Standard of Care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bonvadis® (NWBOT)Bonvadis® (NWBOT) is a topical therapy for wound bed optimization. | Device | Bonvadis® (NWBOT) |
| Clostridial Collagenase OintmentClostridial Collagenase Ointment is an enzymatic debridement therapy that selectively removes devitalized collagen to support wound bed preparation. | Device | Clostridial Collagenase Ointment |
Primary outcome
Percent area reduction (PAR)
Time frame: 4 weeks after initial treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bonvadis® (NWBOT) and Clostridial Collagenase Ointment in people with Diabetic Foot Ulcers (DFUs), run by Oneness Biotech Co., Ltd. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent area reduction (PAR) (time frame: 4 weeks after initial treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.