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

Official title

The SEMAFOOT2 Pilot Effect of Semaglutide on Healing of Foot Ulcers in Type 2 Diabetes Patients

Overview

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.

Interventions

• Drug Semaglutide, 1.34 mg/mL
  pen for subcutaneous injections
• Drug Placebo
  pen for subcutaneous injections

Primary outcome measures

• Proportion of clinical healed index foot ulcer at week 20 [Time frame: 20 weeks]

Secondary outcome measures (3)

• Change in ulcer area after 20 weeks of intervention [Time frame: 20 weeks]
• Change in ulcer area from time of randomization until 8 and 16 weeks of intervention [Time frame: 8 and 16 weeks]
• Change in distal blood pressure from time of randomization until after 20 weeks of intervention [Time frame: 20 weeks]

Eligibility criteria

Inclusion 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.

Exclusion criteria

• 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 interventional 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 menstrual period or with a positive highly sensitive pregnancy test).
• 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 hormonal contraception (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence).
• 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 containing) hormonal contraception (oral, intravaginal, transdermal), progestogen-only hormonal contraception (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion).
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Denmark · 1 center

• Copenhagen Wound Healing Center, Bispebjerg University Hospital — Copenhagen

Identifiers

NCT: NCT07581145 · CODIF-015 · 2023-504913-65-01 · U1111-1282-3930

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗