Tiny cuts may speed healing of diabetic foot ulcers
NCT ID NCT05189470
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new method called inforatio to help heal diabetic foot ulcers. The technique involves making small cuts in the wound to trigger the body's natural healing response. 100 adults with diabetes and foot ulcers that had not healed for at least 6 weeks took part. The goal was to see if this approach leads to complete wound closure.
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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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100 people
The number who actually took part.
- Started
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Mar 2022
- Finished
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Aug 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
INCLUSION CRITERIA * Age ≥ 18 years * Diabetes mellitus * Non-surgical ulcer located distal to the malleoli * Wound diameter \>4 millimeters * Patient-reported wound duration ≥ 6 weeks Only one ulcer will be included from each participant. If a patient has more than one eligible ulcer, the largest ulcer is included. In case of equally sized ulcers, the ulcer with the most recent onset is included. EXCLUSION CRITERIA * Dementia or other reasons that cause inability to give informed consent * Malignant disease * Current treatment with systemic immunosuppressive drugs. Exclusion criteria related to the index extremity: * Diagnosed with or awaiting evaluation of suspected acute phase Charcot arthropathy or osteomyelitis * Non-palpable pulse in both arteria dorsalis pedis and arteria tibialis posterior accompanied by systolic toe pressure \<30 mmHg in the index foot. * Amputation at midfoot level or proximal to midfoot level * Revascularization procedure awaits or has been undertaken within the last 8 weeks or the patient awaits a vascular surgeons' decision on revascularization * Gangrene Exclusion criteria related to the index ulcer * Infection of the ulcer defined according to IWGDF/IDSA (International Working Group on the Diabetic Foot/ Infectious Diseases Society of America system) classification as presence of at least 2 of the following; 1) local swelling or induration; 2) erythema \>0.5 to ≤2 cm around the ulcer; 3) local tenderness or pain; 4) local warmth; or 5) purulent discharge. Current antibiotic treatment due to infection of the index ulcer will also be considered as an ongoing infection regardless of presence of clinical signs of infection. * Positive probe-to-bone test * Exposed joint or tendon * The soft tissue layer covering bone or joint is evaluated to be too thin to allow for inforatio technique anywhere in the wound bed. * Interdigital ulcer location
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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.
Contacts and locations
Locations
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Herlev University Hospital, Department of Orthopaedic Surgery
Herlev, 2730, Denmark
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Nykoebing Falster Hospital
Nykøbing Falster, 4800, Denmark
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Slagelse Hospital, Department of Orthopaedic Surgery
Slagelse, 4200, Denmark
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Zealand University Hospital, Department of Orthopaedic Surgery
Køge, 4600, Denmark
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Other studies related to the condition(s) this trial covers.
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