ClinicalTrials.gg
Not yet recruitingNCT07779239Updated Aug 21, 2026

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

An interventional study of Bonvadis® (NWBOT) and Clostridial Collagenase Ointment in Diabetic Foot Ulcers (DFUs), sponsored by Oneness Biotech Co., Ltd.. Not yet recruiting at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Oneness Biotech Co., Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 381 studies in Diabetic Foot with a site in United States — 67 open to participants now, 86 under way, 3 of them phase 3. Diabetic Foot · United States.

Planned enrollment
112th of 322
100 · median 60
Started
2026
with 13 others
No phase
186 of 381
39 open now
Primary completion
2026-09
later than 38 of 85 live
Registered
379th of 381
by date

Among the 381 studies in Diabetic Foot with a site in United States, this one is the 112th largest by planned enrollment of the 322 interventional ones that give a count, is one of 14 that started in 2026, is one of 186 with no phase, reaches primary completion later than 38 of the 85 other live ones, and was the 379th registered.

Diabetic Foot

1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

Browse Diabetic Foot studies →

Open to participants now

67 of the 381 studies in Diabetic Foot with a site in United States are open now. Recruiting first, the newest first:

62 more — sign in →

All 67 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 137 Diabetic Foot studies recruiting now, 96 (70%) set no upper age limit and 12 (9%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 381 studies in Diabetic Foot with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Diabetic Foot Ulcers (DFUs)

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and comply with study procedures.

Exclusion criteria

Exclusion Criteria:

  1. Target ulcer is not diabetic in origin or has exposed tendon or bone.
  2. ulcer-related complications that, in the investigator's judgment, would interfere with study participation or wound assessment.
  3. Use of , cytotoxic, biologic, or other medications expected to interfere with wound healing.
  4. Recent topical 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 product within the previous 30 days.
  8. Any medical, psychological, nutritional, or 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Bonvadis® (NWBOT)

    Eligible subjects will be assigned to receive Bonvadis® (NWBOT) plus Standard of Care.

    Device: Bonvadis® (NWBOT)

  • Active comparator
    Clostridial Collagenase Ointment

    Eligible subjects will be assigned to receive Clostridial Collagenase Ointment plus Standard of Care.

    Device: Clostridial Collagenase Ointment

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.

06

What researchers measure

Primary outcomes

  1. Percent area reduction (PAR)

    Time frame: 4 weeks after initial treatment

07

Study locations

10 sites
  • Site #4
    North Port, Florida 34289, United States
  • Site #3
    Palm Coast, Florida 32164, United States
  • Site #6
    South Miami, Florida 33143, United States
  • Site #2
    Metairie, Louisiana 70001, United States
  • Site #8
    Brooklyn, New York 11234, United States
  • Site #7
    Akron, Ohio 44308, United States
  • Site #10
    Circleville, Ohio 43113, United States
  • Site #9
    Tulsa, Oklahoma 74135, United States
  • Site #1
    Monroeville, Pennsylvania 15146, United States
  • Site #5
    Philadelphia, Pennsylvania 19125, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Sep 2026, 1 month later.

Of 103 industry-sponsored interventional studies with no phase under Diabetic Foot, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's planned 1 month is below that.

Counting every sponsor, half of 343 studies reached it within 22 months; a quarter within 9 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2026
First posted
Aug 21, 2026
StartEst.
Aug 2026
Primary completionEst.
Sep 2026
CompletionEst.
Sep 2027
Last update
Aug 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07779239
Lead sponsor
Oneness Biotech Co., Ltd.
Responsible party
Sponsor
First posted
Aug 21, 2026
Start date
Aug 2026 (estimated)
Primary completion
Sep 2026 (estimated)
Completion
Sep 2027 (estimated)
Last update
Aug 21, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion