Effect of Semaglutide on Healing of Foot Ulcers in Type 2 Diabetes Patients

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-90
SponsorOle Lander Svendsen

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Semaglutide, 1.34 mg/mL
  • Placebo

Treatment groups

52 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ole Lander Svendsen

Lead sponsor

University Hospital Bispebjerg and Frederiksberg

Sponsor institution