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Tiny cuts may speed healing of diabetic foot ulcers

NCT ID NCT05189470

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

100 people

The number who actually took part.

Started

Mar 2022

Finished

Aug 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Diabetes Complications diabetes mellitus Diabetic Foot Foot Ulcer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Herlev University Hospital, Department of Orthopaedic Surgery

    Herlev, 2730, Denmark

  • Nykoebing Falster Hospital

    Nykøbing Falster, 4800, Denmark

  • Slagelse Hospital, Department of Orthopaedic Surgery

    Slagelse, 4200, Denmark

  • Zealand University Hospital, Department of Orthopaedic Surgery

    Køge, 4600, Denmark

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