Can a new gel outperform standard care for diabetic foot ulcers?
NCT ID NCT07779239
First seen Aug 21, 2026 · Last updated Aug 21, 2026
Summary
This trial compares a new topical gel called Bonvadis to standard care and other treatments for diabetic foot ulcers. The study includes adults with diabetes who have a foot ulcer with limited granulation tissue. The main goal is to see how much the ulcer shrinks in area over time, helping determine if this new approach could improve healing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bonvadis® (NWBOT), a topical wound bed optimization gel, compared with clostridial collagenase ointment and other standard care options.
- What this could lead to
- If Bonvadis works better than current treatments, it could offer a more effective way to heal diabetic foot ulcers and reduce the risk of serious complications.
- What could go wrong
- This is a relatively small trial, and results may not apply to all patients. The new gel might not outperform existing treatments, and any topical therapy carries a risk of skin irritation or infection.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Site #1
Monroeville, Pennsylvania, 15146, United States
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Site #10
Circleville, Ohio, 43113, United States
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Site #2
Metairie, Louisiana, 70001, United States
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Site #3
Palm Coast, Florida, 32164, United States
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Site #4
North Port, Florida, 34289, United States
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Site #5
Philadelphia, Pennsylvania, 19125, United States
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Site #6
South Miami, Florida, 33143, United States
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Site #7
Akron, Ohio, 44308, United States
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Site #8
Brooklyn, New York, 11234, United States
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Site #9
Tulsa, Oklahoma, 74135, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New gel could fight infections in diabetic foot ulcers
- New dressing uses nitric oxide to fight diabetic foot ulcers
- New wound patch could speed healing of diabetic foot sores
- Pig liver bandage shows promise for stubborn wounds in small new study
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