Efficacy of Semaglutide on Time to Wound Closure in Patients with Diabetic Foot Ulcers

The primary objective is to evaluate the effect of semaglutide on the time to wound closure in patients presenting with a diabetic foot ulcer. This study is classified under therapy (Scope 3).

The secondary objectives include the following:

• The proportion of patients achieving a greater than 50% reduction in ulcer surface area after 6 weeks of treatment.
• Changes in ulcer depth and surface area over time.
• Improvement in limb vascular status.
• The rate of amputation.
• The frequency of endovascular interventions.
• The incidence of infection.

The sponsor did not provide information regarding the total number of participants. The study population consists of patients with type 2 diabetes mellitus and an active diabetic foot ulcer. Participants include both males and females within the age range of 18 to 65 years. Inclusion requires proficiency in either Dutch or English.

This clinical trial is designed to evaluate the efficacy of semaglutide in promoting wound closure in individuals with a diabetic foot ulcer. The study utilizes a low-intervention design where the investigational product is administered as part of routine care alongside the standard of care, and no placebo is assigned to the control group. The primary objective is to determine the time to wound closure. Secondary endpoints include the rate of reduction in ulcer surface area, changes in ankle-brachial index or toe pressure, rates of lower limb amputation, endovascular intervention, and infection. Eligible participants must have type 2 diabetes mellitus, an active ulcer, be over 18 years of age, and be proficient in Dutch or English. The study is estimated to take place between January 2026 and January 2028.

The experimental treatment consists of semaglutide, provided as a solution for injection in a pre-filled pen. The administered dose is 2 mg via subcutaneous injection.

The primary efficacy endpoint is the time to wound closure, measured in weeks, for patients with a diabetic foot ulcer receiving semaglutide compared to standard of care.

Secondary endpoints include:

• The rate of more than 50% reduction in ulcer surface area after 6 weeks of treatment, excluding newly formed ulcers.
• Measurements of ulcer surface area and depth at each outpatient clinic visit relative to baseline.
• Changes in ankle-brachial index or toe pressure from inclusion through 6 months of follow-up after wound closure.
• The rate of lower limb amputation.
• The rate of endovascular intervention in the lower extremities.
• The rate of infection.