SEMAFOOT2

RecruitingPhase 3

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

The SEMAFOOT2 Pilot Effect of Semaglutide on Healing of Foot Ulcers in Type 2 Diabetes Patients

Lead sponsor

Ole Lander Svendsen

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Type 2 diabetes

Eligibility highlights

Primary endpoint

•Proportion of clinical healed index foot ulcer

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07581145

Org study IDCODIF-015

Secondary ID2023-504913-65-01

Secondary IDU1111-1282-3930UTN

Timeline

Milestones

Study start2026-04-24actual

Study first posted2026-05-12actual

Last update posted2026-05-12actual

Primary completion2028-12estimated (month precision)

Study completion2029-12estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint/low confidence

Change in distal blood pressure from time of randomization until after 20 weeks of intervention

Time frame:20 weeks

change from baseline, improvement

Other clinical outcomes

3 endpoints

Primary/protocol endpoint

Proportion of clinical healed index foot ulcer at week 20

Time frame:20 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Change in ulcer area after 20 weeks of intervention

Time frame:20 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in ulcer area from time of randomization until 8 and 16 weeks of intervention

Time frame:8 and 16 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.