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

Sponsor
Ole Lander Svendsen
Study ID
NCT07581145
Phase
PHASE3
Status
Recruiting
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Conditions

  • Foot Ulcer Due to Type 2 Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Apr 24, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: semaglutide
    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.
  • Placebo Comparator: Placebo
    The placebo group will receive blinded injection placebo subcutaneously once weekly, up titrated like semaglutide, as described above

Primary Outcome Measure

Proportion of clinical healed index foot ulcer at week 20 [ Time Frame: 20 weeks ]

Central Contacts

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