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Evaluating the effect of semaglutide on wound healing in patients with diabetic foot ulcers

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to evaluate the effect of semaglutide on the time it takes for wounds to close in individuals living with a diabetic foot ulcer. A diabetic foot ulcer is an open sore or wound located on the foot that is caused by complications related to diabetes. Participants will receive either semaglutide or the standard medical care currently used to treat these wounds.

The medication semaglutide is administered through a subcutaneous injection, which is a method of delivering medicine into the fatty layer of tissue just beneath the skin. During the course of the study, the size and depth of the wounds will be monitored, and the healing process will be observed over a period of time to determine how effectively the treatment works compared to standard treatments.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment phase

    The treatment involves receiving semaglutide, which is administered through a subcutaneous injection. this means the medicine is injected into the fatty layer of tissue just under the skin.

    The specific dose of ozempic used during this phase may be 0.25 mg, 0.5 mg, 1 mg, or 2 mg, depending on the assigned treatment group.

  2. Step 2

    Monitoring and measurements

    Regular visits to an outpatient clinic are required to measure the surface area and depth of the diabetic foot ulcer (a wound on the foot caused by diabetes).

    Measurements of the ankle-brachial index and toe pressure, which assess blood flow to the lower limbs, are taken at the beginning and after the wound has closed.

  3. Step 3

    Follow-up

    After the wound closure is achieved, a 6-month follow-up period is conducted to monitor the healing process and any related health changes.

Who can join the trial?

4 criteria

  • You must have type 2 diabetes mellitus, which is a long-term condition that affects how your body processes blood sugar.
  • You must have an active diabetic foot ulcer, which is an open sore or wound on the foot caused by diabetes that is currently present.
  • You must be older than 18 years of age.
  • You must be able to communicate well in either Dutch or English.

Who cannot join the trial?

7 criteria

  • People who are currently using or have used a GLP-1RA or GLP-1/GIP co-agonist (types of medications used to manage blood sugar) within the last 6 months.
  • Anyone with an allergy (an extreme immune system reaction) to any of the ingredients found in the semaglutide injections.
  • People who are currently pregnant.
  • Anyone who has previously had pancreatitis (inflammation of the pancreas, an organ behind the stomach) that was caused by using GLP-1RA medications.
  • People with end-stage renal disease, which means the kidneys are no longer working properly; this is defined as having an estimated GFR (a measure of how well the kidneys filter blood) of less than 15 or needing renal replacement therapy (such as dialysis to clean the blood).
  • People currently using anti-inflammatory therapy, such as prednisolone (a type of medicine used to reduce swelling and inflammation in the body).
  • People whose life expectancy (expected remaining lifespan) is less than 3 months.
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Investigated drugs

Semaglutide is a medication given as a shot under the skin to help study its effect on how quickly diabetic foot wounds can heal and close.

What is already known about the treatment

Semaglutide - This medication is a solution administered via a subcutaneous injection using a pre-filled pen. It is a well-established treatment used primarily to manage blood sugar levels in people with type 2 diabetes. On a molecular level, it works by mimicking a natural hormone that stimulates the pancreas to release insulin and slows down digestion. It belongs to a class of drugs known as GLP-1 receptor agonists.

Investigated diseases

Diabetic foot ulcer - This condition involves a break in the skin on the foot of an individual with diabetes. It often begins as a small sore or blister that fails to heal properly. The progression can involve the wound increasing in surface area or depth over time. Poor blood flow and nerve damage in the feet often contribute to how the wound develops. As it worsens, the area may become more deeply affected by skin breakdown.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524738-24-00Protocol codeR0126321AEstimated enrolment70 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

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