SEMAGLUTIDE for Type 2 diabetes | Diabetic foot ulcer

Inclusion criteria

• {"criterion_text":"- At the Screening visit: •\tDiagnosis of type 2 diabetes mellitus for at least 6 months"}
• {"criterion_text":"- •\tAge 18–90 years"}
• {"criterion_text":"- •\tA foot ulcer below the level of the malleoli. If more than one ulcer, the largest will be selected at screening as the index ulcer."}
• {"criterion_text":"- •\t Wound area after sharp debridement of ≥ 5 mm2, but ≤ 3000 mm2."}

Exclusion criteria

• {"criterion_text":"- At the Screening visit: •\tCurrent use, or recent use (< 3 months), of GLP-1 agonists"}
• {"criterion_text":"- •\tCurrent use of DPP-IV inhibitors"}
• {"criterion_text":"- •\tPrevious acute pancreatitis"}
• {"criterion_text":"- •\tSigns of infection of the index ulcer"}
• {"criterion_text":"- •\tToe blood pressure < 40 mmHg at the foot with the index ulcer"}
• {"criterion_text":"- •\tCurrent treatment with cytotoxic drugs or with systemically administered glucocorticoids"}
• {"criterion_text":"- •\tHospitalisation for a major cardiovascular event or procedure or revascularization surgery on a leg in the last 3 months, or scheduled major cardiovascular intervention"}
• {"criterion_text":"- •\tContraindication/intolerance to study medication"}
• {"criterion_text":"- •\tPre-existing medical condition judged to preclude safe participation in the study"}
• {"criterion_text":"- •\tAbuse of alcohol or drugs, or presence of any condition that in the Investigators opinion may lead to poor adherence to study protocol"}
• {"criterion_text":"- •\tRecent use (< 3 months) of an investigational drug or participation in interventional clinical foot ulcer-healing trial"}
• {"criterion_text":"- •\tPregnancy, breast feeding or planning pregnancy or not using adequate contraceptive methods (adequate contraceptive measures are an intrauterine device or oral contraceptives)."}
• {"criterion_text":"- •\tLikely inability to comply with the need for weekly visits because of planned activity"}
• {"criterion_text":"- •\tMental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation"}
• {"criterion_text":"- •\tUnable to provide written and signed informed consent."}
• {"criterion_text":"- •\tUse of any drug which in the Investigator’s opinion could interfere with the healing of foot ulcers."}
• {"criterion_text":"- •\tAny 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"}
• {"criterion_text":"- •\tActive cancer or a history of cancer in the 3 years prior to signing the informed consent form (history of basal cell carcinoma is allowed)."}
• {"criterion_text":"- •\tLife expectancy of less than 12 months."}
• {"criterion_text":"- •\tWounds caused primarily by untreated vascular insufficiency, or where patients are primarily eligible for vascular intervention to promote wound healing."}
• {"criterion_text":"- •\tWounds with an etiology not related to diabetes."}
• {"criterion_text":"- •\tUnderlying osteomyelitis of the leg with the wound to be treated."}
• {"criterion_text":"- •\tPatients 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)."}
• {"criterion_text":"- •\tSurgery to lengthen Achilles tendon on the leg with the wound to be treated 3 months prior to signing the informed consent form."}
• {"criterion_text":"- •\tNecrosis, purulence, or sinus tracts that cannot be removed by debridement on foot to be treated."}

Primary endpoints

• {"endpoint_text":"- Proportion of index ulcers completely healed after 20 weeks of intervention","definition_or_measurement_approach":"Proportion of index ulcers that are completely healed assessed after 20 weeks of intervention (endpoint text specifies assessment at 20 weeks)."}

Secondary endpoints

• {"endpoint_text":"- Change in ulcer area from time of randomization until after 20 weeks of intervention","definition_or_measurement_approach":"Change in ulcer area measured from time of randomization to after 20 weeks of intervention (area change over the 20-week intervention period)."}

Denmark

Earliest CTIS Part Ii Submission Date

06-06-2025

Latest Decision Or Authorization Date

29-09-2025

Processing Time Days

115

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

Bispebjerg Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"Sponsor duties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}