The SEMAFOOT2 Pilot Effect of Semaglutide on Healing of Foot Ulcers in Type 2 Diabetes Patients
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Denmark
Copenhagen Wound Healing Center, Bispebjerg University Hospital
RECRUITING
Copenhagen
Contact Information
Primary
Ole L Svendsen, MD
ole.lander.svendsen@regionh.dk
+45 21830863
Backup
klaus Kirketerp-Møller, MD
klaus.kirketerp-moeller.01@regionh.dk
+4538635134
Time Frame
Start Date: 2026-04-24
Estimated Completion Date: 2029-12
Participants
Target number of participants: 52
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Ole Lander Svendsen