Semaglutide to help heal foot ulcers in people with type 2 diabetes
The SEMAFOOT2 Pilot Effect of Semaglutide on Healing of Foot Ulcers in Type 2 Diabetes Patients
This 20-week randomized, double-blind trial will try semaglutide versus placebo to see if it helps heal foot ulcers in adults with type 2 diabetes.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University Hospital Bispebjerg and Frederiksberg Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT07581145 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled Phase 3 study administers semaglutide or matching placebo over 20 weeks to adults with type 2 diabetes who have a foot ulcer below the malleoli. The largest ulcer per participant is selected as the index wound and must have a debrided area between 5 mm2 and 3000 mm2. Key exclusions include recent GLP‑1 or DPP‑IV use, signs of ulcer infection, very low toe blood pressure, recent major cardiovascular events, or other contraindicating conditions. Wound healing outcomes and safety measures will be compared between the semaglutide and placebo groups.
Who should consider this trial
Good fit: Adults age 18–90 with type 2 diabetes for at least 6 months who have a foot ulcer below the malleoli with a debrided wound area of 5–3000 mm2 and who are able to attend study visits and are not currently using GLP‑1 agonists are ideal candidates.
Not a fit: Patients with infected index ulcers, toe blood pressure below 40 mmHg, recent major cardiovascular events or leg revascularization, recent GLP‑1/DPP‑IV use, prior acute pancreatitis, current systemic cytotoxic or glucocorticoid therapy, or other contraindications are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, semaglutide could speed ulcer closure and reduce the risk of infection and amputation in people with diabetic foot ulcers.
How similar studies have performed: GLP‑1 receptor agonists such as semaglutide are well established for glycemic control and weight loss, but clinical evidence that they directly improve diabetic foot ulcer healing is limited, so this is a relatively novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Copenhagen
- Copenhagen Wound Healing Center, Bispebjerg University Hospital — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Ole L Svendsen, MD
- Email: ole.lander.svendsen@regionh.dk
- Phone: +45 21830863
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.