Foot Ulcer Due to Type 2 Diabetes MellitusPhase 3SEMAFOOT2NCT07581145
Effect of Semaglutide on Healing of Foot Ulcers in Type 2 Diabetes Patients
A Phase 3 study testing Semaglutide, 1.34 mg/mL in people with Foot Ulcer Due to Type 2 Diabetes Mellitus, run by Ole Lander Svendsen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Foot Ulcer Due to Type 2 Diabetes Mellitus
- What is being tested?
- Semaglutide, 1.34 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Apr 2026to Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 28Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen Wound Healing Center, Bispebjerg University Hospital
Copenhagen, 2400
Ole L Svendsen, MD, +45 21830863, ole.lander.svendsen@regionh.dk
klaus Kirketerp-Møller, MD, +4538635134, klaus.kirketerp-moeller.01@regionh.dk
About this study
Official title: The SEMAFOOT2 Pilot Effect of Semaglutide on Healing of Foot Ulcers in Type 2 Diabetes Patients
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.
- Being tested
- Semaglutide, 1.34 mg/mL, Placebo
- Keywords
- semaglutide, randomized clinical trial, diabetic foot ulcer
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide, 1.34 mg/mLDrug
Also called ozempic
pen for subcutaneous injections
PlaceboDrug
pen for subcutaneous injections
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 weeks
Secondary outcomes (3)
Change in ulcer area after 20 weeks of intervention
Difference between the groups treated with semalutide and with placebo in change in ulcer area after 20 weeks of intervention.
The index ulcers will be photographed using a standard camera. The distance from the ulcer will be appriximately 30 cm and a standard setting will be used for each photograph. A reference ruler will be included in the photograph and located beside the ulcer. The ulcer will be photographed 3 times and stored electronically. The ulcer area will be analyzed using ImageJ software v 1.47 (NIH).
Measured: 20 weeks
Change in ulcer area from time of randomization until 8 and 16 weeks of intervention
Difference between the groups treated with semalutide and with placebo in index ulcer area.
The index ulcers will be photographed using a standard camera. The distance from the ulcer will be approximately 30 cm and a standard setting will be used for each photograph. A reference ruler will be included in the photograph and located beside the ulcer. The ulcer will be photographed 3 times and stored electronically. The ulcer area will be analyzed using ImageJ software v 1.47 (NIH).
Measured: 8 and 16 weeks
Change in distal blood pressure from time of randomization until after 20 weeks of intervention
Difference between the groups treated with semalutide and with placebo
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start24 Apr 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ulcer Due to Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- clinical randomized, double-blind, placebo controlled intervention trial with semaglutide or placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ole Lander Svendsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ole Lander Svendsen, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Ole L Svendsen, MD, Study chair, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581145
- Sponsor's protocol ID
- CODIF-015
- Other IDs
- 2023-504913-65-01, U1111-1282-3930, 2023
- Acronym
- SEMAFOOT2
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SEMAFOOT2 Pilot Effect of Semaglutide on Healing of Foot Ulcers in Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT07581145
- Acronym / sponsor ID
- SEMAFOOT2 / CODIF-015
- Keywords
- semaglutide, randomized clinical trial, diabetic foot ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ole Lander SvendsenUniversity, hospital or other
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- clinical randomized, double-blind, placebo controlled intervention trial with semaglutide or placebo
| Arm | Type | Receives |
|---|---|---|
| semaglutide | Experimental | Drug: Semaglutide, 1.34 mg/mLOzempic® (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. |
| Placebo | Placebo comparator | Drug: PlaceboThe placebo group will receive blinded injection placebo subcutaneously once weekly, up titrated like semaglutide, as described above |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide, 1.34 mg/mLAlso: ozempicpen for subcutaneous injections | Drug | semaglutide |
| Placebopen for subcutaneous injections | Drug | Placebo |
Primary outcome
Proportion of clinical healed index foot ulcer at week 20
Time frame: 20 weeks
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.
3 secondary outcomes
Change in ulcer area after 20 weeks of intervention
Time frame: 20 weeks
Change in ulcer area from time of randomization until 8 and 16 weeks of intervention
Time frame: 8 and 16 weeks
Change in distal blood pressure from time of randomization until after 20 weeks of intervention
Time frame: 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
Related trials for Foot Ulcer Due to Type 2 Diabetes Mellitus
RecruitingObservational study
Systemic Biochemical Signature and Functional Quality Index of Calcaneal Bone Marrow Aspirate in Adults Undergoing Foot or Ankle Surgery
Diabetic Foot Ulcer, Wound Healing
RecruitingPhase 4
Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy
Diabetic Foot Ulcer, DFU
RecruitingPhase 4
A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers
Diabetic Foot, Foot Ulcer
RecruitingPhase 1
Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers
Diabetic Foot Ulcer, Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ole L Svendsen, MD study chair
University Hospital Bispebjerg and Frederiksberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semaglutide, 1.34 mg/mL in people with Foot Ulcer Due to Type 2 Diabetes Mellitus, run by Ole Lander Svendsen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ole L Svendsen, MD (+45 21830863, ole.lander.svendsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of clinical healed index foot ulcer at week 20 (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.