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

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What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called semaglutide on the healing of foot ulcers in patients with type 2 diabetes. Foot ulcers are open sores or wounds that occur on the feet, often as a complication of diabetes. The study will compare the healing effects of semaglutide to a placebo, which is a substance with no active medication.

The purpose of the study is to investigate whether semaglutide can help heal foot ulcers in people with type 2 diabetes. Participants in the study will receive semaglutide in the form of a solution for injection, which is administered using a pre-filled pen. The study will involve different doses of semaglutide, including 0.25 mg, 0.5 mg, and 1 mg, given as a subcutaneous injection, which means it is injected under the skin.

The study will last for a period of 20 weeks, during which the healing of the foot ulcers will be monitored. The main goal is to see how many of the ulcers are completely healed after this period. Additionally, the study will look at changes in the size of the ulcers from the start to the end of the study. This research aims to provide valuable information on the potential benefits of semaglutide for patients with diabetic foot ulcers.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the purpose and procedures involved. The study aims to investigate the effect of semaglutide on healing foot ulcers in patients with type 2 diabetes.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying your diagnosis of type 2 diabetes for at least six months, your age (18-90 years), and the presence of a foot ulcer below the ankle. The largest ulcer will be selected as the index ulcer for the study.

  3. Step 3

    Treatment phase

    During the treatment phase, you will receive semaglutide or a placebo. The medication is administered as a subcutaneous injection, which means it is injected under the skin.

    The dosage of semaglutide will vary: 0.25 mg, 0.5 mg, or 1 mg, depending on the study group you are assigned to. The injections are given once a week for a duration of 20 weeks.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, regular monitoring will be conducted to assess the healing of the index ulcer. The primary goal is to determine the proportion of ulcers that completely heal after 20 weeks.

    Secondary assessments will include measuring any changes in the ulcer area from the start of the study until the end of the 20-week period.

  5. Step 5

    Completion of the study

    At the end of the study, a final evaluation will be conducted to gather data on the healing progress of your foot ulcer. This information will contribute to understanding the effectiveness of semaglutide in treating foot ulcers in type 2 diabetes patients.

Who can join the trial?

4 criteria

  • Have a diagnosis of type 2 diabetes for at least 6 months.
  • Be between the ages of 18 and 90 years old.
  • Have a foot ulcer below the level of the ankle bones (malleoli). If there is more than one ulcer, the largest one will be chosen for the study.
  • The wound area after cleaning should be at least 5 square millimeters but not more than 3000 square millimeters. A square millimeter is a way to measure the size of the wound.

Who cannot join the trial?

9 criteria

  • Patients with any other serious medical condition that might affect their participation in the study.
  • Patients who have had a recent heart attack or stroke.
  • Patients with severe kidney disease.
  • Patients with severe liver disease.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have an allergy to the study medication or similar drugs.
  • Patients who are unable to follow the study procedures.
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Investigated drugs

Semaglutide is a medication used in this clinical trial to help heal foot ulcers in patients with type 2 diabetes. It works by mimicking a hormone in the body that helps control blood sugar levels. By doing so, it may improve blood flow and promote healing in areas like foot ulcers, which are common complications in people with diabetes. This trial aims to see if semaglutide can effectively aid in the healing process of these ulcers compared to not using it.

What is already known about the treatment

Semaglutide – Semaglutide is administered as an injection under the skin, typically once a week. It is currently being studied for its potential to help heal foot ulcers in patients with type 2 diabetes, as part of ongoing clinical trials. The main therapeutic use of semaglutide is to manage blood sugar levels in people with type 2 diabetes, and researchers are exploring its benefits for diabetic foot ulcers. At the molecular level, semaglutide works by mimicking a natural hormone in the body that helps regulate insulin and blood sugar levels. It belongs to a class of drugs known as GLP-1 receptor agonists, which help improve blood sugar control and may have additional benefits for healing.

Investigated diseases

  • Type 2 Diabetes

    Type 2 diabetes is a chronic condition that affects the way the body processes blood sugar (glucose). It is characterized by insulin resistance, where the body's cells do not respond properly to insulin, and eventually, the pancreas may not produce enough insulin. Over time, high blood sugar levels can lead to various complications, including damage to the eyes, kidneys, nerves, and heart. The disease often develops gradually and may initially present with symptoms such as increased thirst, frequent urination, and fatigue. As the condition progresses, individuals may experience more severe complications if blood sugar levels are not managed effectively. Lifestyle factors, such as diet and physical activity, play a significant role in the development and progression of type 2 diabetes.

  • Diabetic Foot Ulcer

    A diabetic foot ulcer is an open sore or wound that occurs on the foot of a person with diabetes. It is a common complication of diabetes, resulting from a combination of factors such as poor circulation, nerve damage (neuropathy), and high blood sugar levels. The ulcer typically develops on the bottom of the foot and can become infected if not properly cared for. As the ulcer progresses, it may lead to tissue damage and, in severe cases, affect deeper structures like tendons and bones. The healing process can be slow, especially if blood sugar levels are not well-controlled. Preventive care and regular monitoring are crucial to managing and reducing the risk of diabetic foot ulcers.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504913-65-01Protocol codeCODIF-015Estimated enrolment100 patientsSponsorRegion Hovedstaden

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