Clinical trial • Not applicable • Cardiology|Endocrinology
semaglutide for Diabetic foot ulcer | Type 2 diabetes mellitus
Not applicable trial of semaglutide for Diabetic foot ulcer | Type 2 diabetes mellitus.
Overview
- Trial Therapeutic Area
- Cardiology|Endocrinology
- Trial Disease
- Diabetic foot ulcer | Type 2 diabetes mellitus
- Trial Stage
- Not applicable
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 02-12-2025
- First CTIS Authorization Date
- 30-03-2026
Trial design
Usual care / standard of care (control group receives standard of care treatment) Not applicable trial in Netherlands.
- Comparator
- Usual care / standard of care (control group receives standard of care treatment)
- Real World Control
- Yes
- Target Sample Size
- 70
- Trial Duration For Participant
- 182
Eligibility
Recruits 70 No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants must be >18 years. Subject information and informed consent form available (L1_PIF_redacted document present). Participants must be proficient in Dutch or English..
- Pregnancy Exclusion
- Current pregnancy
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants must be >18 years. Subject information and informed consent form available (L1_PIF_redacted document present). Participants must be proficient in Dutch or English.
Inclusion criteria
- {"criterion_text":"- Have type 2 diabetes mellitus (T2DM)\n- Presence of an active diabetic foot ulcer\n- Age >18 years\n- Be proficient in either Dutch or English"}
Exclusion criteria
- {"criterion_text":"- Those with current use or who used a GLP-1RA or GLP-1/GIP co-agonist in the previous 6 months.\n- Any contra-indication for semaglutide as outlined in the EPAR (which only consists of allergy to the contents of semaglutide injections)\n- Current pregnancy\n- Previous pancreatitis attributed to use of GLP-1RA\n- End-stage renal disease (defined as estimated-GFR <15 mL/min/m2 or the use of renal replacement therapy)\n- Current use of anti-inflammatory therapy, e.g. prednisolone\n- Life expectancy <3 months"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Time (in weeks) to wound closure in patients with a DFU using semaglutide versus standard of care treatment.","definition_or_measurement_approach":"Time in weeks to wound closure comparing semaglutide versus standard of care treatment (measured as weeks until wound closure)."}
Secondary endpoints
- {"endpoint_text":"- Rate of >50% reduction in ulcer surface area after 6 week of treatment between study groups (excluding newly formed ulcers)","definition_or_measurement_approach":"Proportion of patients achieving >50% reduction in ulcer surface area at 6 weeks (excluding newly formed ulcers)."}
- {"endpoint_text":"- Ulcer surface area and depth at every outpatient clinic (relative to baseline)","definition_or_measurement_approach":"Change in ulcer surface area and depth at each outpatient visit relative to baseline."}
- {"endpoint_text":"- The change in ankle-brachial index/toe pressure measurements over time (at inclusion, and after wound closure of 6 months of follow-up)","definition_or_measurement_approach":"Change in ankle-brachial index and toe pressure measurements from inclusion and after wound closure or at 6 months follow-up."}
- {"endpoint_text":"- Rate of lower limb amputation","definition_or_measurement_approach":"Incidence rate of lower limb amputations during follow-up."}
- {"endpoint_text":"- Rate of endovascular intervention in lower extremities","definition_or_measurement_approach":"Incidence rate of endovascular interventions in lower extremities during follow-up."}
- {"endpoint_text":"- Rate of infection","definition_or_measurement_approach":"Incidence rate of infections during follow-up."}
Recruitment
- Planned Sample Size
- 70
- Recruitment Window Months
- 24
- Consent Approach
- Informed consent provided by the participant; Subject information and informed consent form available (L1_PIF_redacted). Participants must be proficient in Dutch or English.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 70
Netherlands
- Earliest CTIS Part Ii Submission Date
- 18-03-2026
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 12
- Number Of Sites
- 1
- Number Of Participants
- 70
Sites
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Internal Medicine
- Principal Investigator Name
- Teba Alnima
- Principal Investigator Email
- teba.alnima@radboudumc.nl
- Contact Person Name
- Teba Alnima
- Contact Person Email
- teba.alnima@radboudumc.nl
- Number Of Participants
- 70
Sponsor
Primary sponsor
- Full Name
- Radboud universitair medisch centrum Stichting
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- Ozempic 2 mg solution for injection in pre-filled pen
- Active Substance
- semaglutide
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous injection
- Route
- Subcutaneous injection
- Authorisation Status
- Authorised (marketing authorisation present)
- Dose Levels
- 2 mg
- Maximum Dose
- 2 mg
- Investigational Product Name
- Ozempic 1 mg solution for injection in pre-filled pen
- Active Substance
- semaglutide
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous injection
- Route
- Subcutaneous injection
- Authorisation Status
- Authorised (marketing authorisation present)
- Dose Levels
- 1 mg
- Maximum Dose
- 2 mg
- Investigational Product Name
- Ozempic 0.5 mg solution for injection in pre-filled pen
- Active Substance
- semaglutide
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous injection
- Route
- Subcutaneous injection
- Authorisation Status
- Authorised (marketing authorisation present)
- Dose Levels
- 0.5 mg
- Maximum Dose
- 2 mg
- Investigational Product Name
- Ozempic 0.25 mg solution for injection in pre-filled pen
- Active Substance
- semaglutide
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous injection
- Route
- Subcutaneous injection
- Authorisation Status
- Authorised (marketing authorisation present)
- Dose Levels
- 0.25 mg
- Maximum Dose
- 2 mg
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