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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
pen for subcutaneous injections
pen for subcutaneous injections
Copenhagen Wound Healing Center, Bispebjerg University Hospital
Copenhagen, Denmark
RECRUITINGProportion of clinical healed index foot ulcer at week 20
Difference between the groups treated with semalutide and with placeebo in proportion of index ulcers completely healed after 20 weeks of intervention. Assessment of complete ulcer healing by naked eye will be performed by trained study staff: Total closure/healed (total epithelization): Yes or No. Complete ulcer healing is defined (as by FDA) as complete skin re-epithelialization without drainage or dressing requirements, confirmed at two consecutive study visit two weeks apart, and the time encountered as healed is the first of the two visits.
Time frame: 20 weeks
Change in ulcer area after 20 weeks of intervention
Difference between the groups treated with semalutide and with placebo in change in ulcer area after 20 weeks of intervention. The index ulcers will be photographed using a standard camera. The distance from the ulcer will be appriximately 30 cm and a standard setting will be used for each photograph. A reference ruler will be included in the photograph and located beside the ulcer. The ulcer will be photographed 3 times and stored electronically. The ulcer area will be analyzed using ImageJ software v 1.47 (NIH).
Time frame: 20 weeks
Change in ulcer area from time of randomization until 8 and 16 weeks of intervention
Difference between the groups treated with semalutide and with placebo in index ulcer area. The index ulcers will be photographed using a standard camera. The distance from the ulcer will be approximately 30 cm and a standard setting will be used for each photograph. A reference ruler will be included in the photograph and located beside the ulcer. The ulcer will be photographed 3 times and stored electronically. The ulcer area will be analyzed using ImageJ software v 1.47 (NIH).
Time frame: 8 and 16 weeks
Change in distal blood pressure from time of randomization until after 20 weeks of intervention
Difference between the groups treated with semalutide and with placebo
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Time frame: 20 weeks