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

NCT07581145 | Recruiting Phase 3

• 3 other identifiers: CODIF-0152023-504913-65-01U1111-1282-3930
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Foot Ulcer Due to Type 2 Diabetes Mellitus

Keywords

semaglutide; randomized clinical trial; diabetic foot ulcer

Outcome Measures

Primary Outcomes (1)

• Proportion of clinical healed index foot ulcer at week 20

  Difference between the groups treated with semalutide and with placeebo in proportion of index ulcers completely healed after 20 weeks of intervention. Assessment of complete ulcer healing by naked eye will be performed by trained study staff: Total closure/healed (total epithelization): Yes or No. Complete ulcer healing is defined (as by FDA) as complete skin re-epithelialization without drainage or dressing requirements, confirmed at two consecutive study visit two weeks apart, and the time encountered as healed is the first of the two visits.

  20 weeks

Secondary Outcomes (3)

• Change in ulcer area after 20 weeks of intervention

  20 weeks

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

  8 and 16 weeks

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

  20 weeks

Study Arms (2)

semaglutide

EXPERIMENTAL

Ozempic® (semaglutide), which comes in prefilled pens, is approved for treatment of adults with insufficiently controlled type 2 diabetes mellitus. This group is treated with semaglutide 1 mg once weekly, with the usual starting dose of injection 0.25 mg semaglutide subcutaneously once weekly (OW). After four weeks the dose will be increased to 0.5 mg OW, and after another four weeks, the dose will be increased to 1.0 mg OW, depending on side effects. Novo Nordisk A/S will deliver the IP and will do so in a way that enables double blind treatment. The strength of the active IP used in this study is semaglutide 1.34 mg/ml.

Drug: Semaglutide, 1.34 mg/mL

Placebo

PLACEBO COMPARATOR

The placebo group will receive blinded injection placebo subcutaneously once weekly, up titrated like semaglutide, as described above

Drug: Placebo

Interventions

Semaglutide, 1.34 mg/mL DRUG

pen for subcutaneous injections

Also known as: ozempic

semaglutide

Placebo DRUG

pen for subcutaneous injections

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Ole Lander Svendsen: lead

Study Sites (1)

Copenhagen Wound Healing Center, Bispebjerg University Hospital

Copenhagen, 2400, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Ole L Svendsen, MD

  University Hospital Bispebjerg and Frederiksberg

  STUDY CHAIR

Central Study Contacts

Ole L Svendsen, MD

CONTACT

+45 21830863; ole.lander.svendsen@regionh.dk

klaus Kirketerp-Møller, MD

CONTACT

+4538635134; klaus.kirketerp-moeller.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blinded IP (semaglutide or placebo)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, Dr Med Sci

Model Details: clinical randomized, double-blind, placebo controlled intervention trial with semaglutide or placebo

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 12, 2026
• Study Start: April 24, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)