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Diabetes drug semaglutide may speed healing of foot sores

NCT ID NCT07581145

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether semaglutide, a diabetes drug, can help heal foot ulcers in people with type 2 diabetes. About 52 adults will receive either semaglutide or a placebo for 20 weeks. The main goal is to see if more ulcers heal completely with the drug. This is an early-phase trial to gather evidence.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 52 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

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 to 90 years

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: * Diagnosis of type 2 diabetes mellitus for at least 6 months * Age 18-90 years * A foot ulcer below the level of the malleoli. If more than one ulcer, the largest will be selected at screening as the index ulcer. * Wound area after sharp debridement of ≥ 5 mm2, but ≤ 3000 mm2. Exclusion Criteria: * Current use, or recent use (\<3 months), of GLP-1 agonists * Current use of DPP-IV inhibitors * Previous acute pancreatitis * Signs of infection of the index ulcer * Toe blood pressure \< 40 mmHg at the foot with the index ulcer * Current treatment with cytotoxic drugs or with systemically administered glucocorticoids * Hospitalisation for a major cardiovascular event or procedure or revascularization surgery on a leg in the last 3 months, or scheduled major cardiovascular intervention * Contraindication/intolerance to study medication * Pre-existing medical condition judged to preclude safe participation in the study * Abuse of alcohol or drugs, or presence of any condition that in the Investigators opinion may lead to poor adherence to study protocol * Recent use (\< 3 months) of an investigational drug or participation in interventional clinical foot ulcer-healing trial * Known pregnancy, breast feeding or planning pregnancy. * Women of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) without a confirmed menstrual period or with a positive highly sensitive pregnancy test). * Women of childbearing potential not using highly effective birth control methods, such as combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal), progestogen-only hormonal contraception (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence). * Men, with female partners of childbearing potential, not vasectomised or not using condoms or sexual abstinence AND the female partner not using highly effective birth control, such as combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal), progestogen-only hormonal contraception (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion). * Likely inability to comply with the need for weekly visits because of planned activity * Mental incapacity, unwillingness, not speaking and understanding Danish or language barrier precluding adequate understanding or cooperation * Unable to provide written and signed informed consent. * Use of any drug which in the Investigator's opinion could interfere with the healing of foot ulcers. * Any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial * Active cancer or a history of cancer in the 3 years prior to signing the informed consent form (history of basal cell carcinoma is allowed). * Life expectancy of less than 12 months. * Wounds caused primarily by untreated vascular insufficiency, or where patients are primarily eligible for vascular intervention to promote wound healing. * Wounds with an etiology not related to diabetes. * Underlying osteomyelitis of the leg with the wound to be treated. * Patients presenting with the clinical characteristics of cellulitis at the wound site (suppurative inflammation involving particularly the subcutaneous tissue, often mild erythema, tenderness, malaise, chills and fever). * Surgery to lengthen Achilles tendon on the leg with the wound to be treated 3 months prior to signing the informed consent form. * Necrosis, purulence, or sinus tracts that cannot be removed by debridement on foot to be treated.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Copenhagen Wound Healing Center, Bispebjerg University Hospital

    RECRUITING

    Copenhagen, 2400, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.