Effect of Semaglutide on Healing of Foot Ulcers in Type 2 Diabetes Patients

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Foot Ulcer Due to Type 2 Diabetes Mellitus

In brief

The aim of this exploratory pilot study is to investigate the effect of semaglutide compared to placebo on healing of foot ulcers in type 2 diabetes patients. It is a randomized double blind, placebo controlled, clinical intervention study of 20 weeks intervention.

Key facts

Study ID

NCT07581145

Run by

Ole Lander Svendsen

People needed

52

Starts

2026-04-24

Expected to finish

2029-12-01

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Copenhagen Wound Healing Center, Bispebjerg University Hospital — Copenhagen, Denmark (enrolling)

Full record on ClinicalTrials.gov

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