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

What Was Tested

The trial (phase 3) is built around Semaglutide.

It is a randomized double blind, placebo controlled, clinical intervention study of 20 weeks intervention.

It had two arms (groups): semaglutide (experimental) and Placebo (placebo comparator).

The placebo group will receive blinded injection placebo subcutaneously once weekly, up titrated like semaglutide, as described above.

The registry classes the interventions as drug.

Who Took Part

52 planned participants were the target.

It was open to people of any sex aged from 18 years up to 90 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 28 exclusion criteria; among the exclusions: current use, or recent use (\<3 months), of glp-1 agonists; current use of dpp-iv inhibitors; previous acute pancreatitis.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-04-24 with completion listed for 2028-12.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Proportion of clinical healed index foot ulcer at week 20 (time frame: 20 weeks).

It also tracked 3 secondary outcomes, for example Change in ulcer area after 20 weeks of intervention, Change in ulcer area from time of randomization until 8 and 16 weeks of intervention and Change in distal blood pressure from time of randomization until after 20 weeks of intervention.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 52 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.