Actively Recruiting
Effect of Semaglutide on Healing of Foot Ulcers in Type 2 Diabetes Patients
Led by Ole Lander Svendsen · Updated on 2026-05-12
52
Participants Needed
1
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Semaglutide on Healing of Foot Ulcers in Type 2 Diabetes Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of type 2 diabetes mellitus for at least 6 months
- Age between 18 and 90 years
- Presence of a foot ulcer below the malleoli; if multiple, the largest is selected as the index ulcer
- Wound area after sharp debridement between 5 mm2 and 3000 mm2
You will not qualify if you...
- Current or recent (within 3 months) use of GLP-1 agonists
- Current use of DPP-IV inhibitors
- Previous acute pancreatitis
- Signs of infection in the index ulcer
- Toe blood pressure below 40 mmHg at the affected foot
- Current treatment with cytotoxic drugs or systemic glucocorticoids
- Hospitalization for major cardiovascular events or leg revascularization surgery in the last 3 months, or planned major cardiovascular intervention
- Contraindication or intolerance to study medication
- Medical conditions that preclude safe study participation
- Alcohol or drug abuse or conditions likely to cause poor adherence
- Recent use of investigational drugs or participation in other foot ulcer healing trials within 3 months
- Known pregnancy, breastfeeding, or planning pregnancy
- Women of childbearing potential not using highly effective birth control methods
- Men with female partners of childbearing potential not using effective contraception
- Likely inability to attend weekly visits due to planned activities
- Mental incapacity, unwillingness, or language barriers preventing cooperation
- Unable to provide written informed consent
- Use of drugs interfering with foot ulcer healing
- Other significant diseases interfering with trial results except diabetes-related conditions
- Active cancer or cancer history within 3 years (except basal cell carcinoma)
- Life expectancy under 12 months
- Wounds primarily from untreated vascular insufficiency or needing vascular intervention
- Wounds not related to diabetes
- Osteomyelitis of the leg with the wound
- Clinical signs of cellulitis at the wound site
- Achilles tendon surgery on affected leg within 3 months
- Necrosis, purulence, or sinus tracts on the foot that cannot be removed by debridement
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Trial Site Locations
Total: 1 location
1
Copenhagen Wound Healing Center, Bispebjerg University Hospital
Copenhagen, Denmark, 2400
Actively Recruiting
Research Team
O
Ole L Svendsen, MD
CONTACT
K
klaus Kirketerp-Møller, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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