The SEMAFOOT2 Pilot. Effect of semaglutide on healing of foot ulcers in type 2 diabetes patients. A Pilot study.

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• At the Screening visit: • 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 • Pregnancy, breast feeding or planning pregnancy or not using adequate contraceptive methods (adequate contraceptive measures are an intrauterine device or oral contraceptives). • Likely inability to comply with the need for weekly visits because of planned activity • Mental incapacity, unwillingness, 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.