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New treatment option for Foot Ulcer Due to Type 2 Diabetes Mellitus
Official title Effect of Semaglutide on Healing of Foot Ulcers in Type 2 Diabetes Patients
ClinicalTrials.gov ID: NCT07581145
What this study is testing
What is Semaglutide, 1.34 mg/mL?
Semaglutide, 1.34 mg/mL is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for foot ulcer due to type 2 diabetes mellitus.
Also referred to as ozempic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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.
You likely can't join if
- 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
- Toe blood pressure \< 40 mmHg at the foot with the index ulcer
- Current treatment with cytotoxic drugs or with systemically administered glucocorticoids
See the full eligibility criteria
- 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.
- 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
- Toe blood pressure \< 40 mmHg at the foot with the index ulcer
- Current treatment with cytotoxic drugs or with systemically administered glucocorticoids
- Hospitalisation for a major cardiovascular event or procedure or revascularization surgery on a leg in the last 3 months, or scheduled major cardiovascular intervention
- Contraindication/intolerance to study medication
- Pre-existing medical condition judged to preclude safe participation in the study
- Abuse of alcohol or drugs, or presence of any condition that in the Investigators opinion may lead to poor adherence to study protocol
- Recent use (\< 3 months) of an investigational drug or participation in treatment clinical foot ulcer-healing trial
- Known pregnancy, breast feeding or planning pregnancy.
- Women of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) without a confirmed...
- Women of childbearing potential not using highly effective birth control methods, such as combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal), progestogen-only...
- Men, with female partners of childbearing potential, not vasectomised or not using condoms or sexual abstinence AND the female partner not using highly effective birth control, such as combined (estrogen and progestogen...
- Likely inability to comply with the need for weekly visits because of planned activity
- Mental incapacity, unwillingness, not speaking and understanding Danish or language barrier precluding adequate understanding or cooperation
- Unable to provide written and signed informed consent.
- Use of any drug which in the Investigator's opinion could interfere with the healing of foot ulcers.
- Any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial
- Active cancer or a history of cancer in the 3 years prior to signing the informed consent form (history of basal cell carcinoma is allowed).
- Life expectancy of less than 12 months.
- Wounds caused primarily by untreated vascular insufficiency, or where patients are primarily eligible for vascular intervention to promote wound healing.
- Wounds with an etiology not related to diabetes.
- Underlying osteomyelitis of the leg with the wound to be treated.
- Patients presenting with the clinical characteristics of cellulitis at the wound site (suppurative inflammation involving particularly the subcutaneous tissue, often mild erythema, tenderness, malaise, chills and fever).
- Surgery to lengthen Achilles tendon on the leg with the wound to be treated 3 months prior to signing the informed consent form.
- Necrosis, purulence, or sinus tracts that cannot be removed by debridement on foot to be treated.
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.