The SEMAFOOT2 Pilot. Effect of semaglutide on healing of foot ulcers in type 2 diabetes patients. A Pilot study.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bispebjerg Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18], Diseases [C] - Hormonal diseases [C19]

Trial duration

24 Apr 2026 → ongoing

Decision date (initial)

2025-06-15

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novo Nordisk A/S · Bispebjerg Hospital

External identifiers

EU CT number

2023-504913-65-01

WHO UTN

U1111-1282-3930

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To investigate the effect of semaglutide compared to placebo on healing of foot ulcers in type 2 diabetes patients.

Secondary objectives 1

1. Change in ulcer area from time of randomization until after 20 weeks of intervention.

Conditions and MedDRA coding

Type 2 diabetes, Diabetic foot ulcer

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. At the Screening visit: • 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 1

1. At the Screening visit: • 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 • Pregnancy, breast feeding or planning pregnancy or not using adequate contraceptive methods (adequate contraceptive measures are an intrauterine device or oral contraceptives). • Likely inability to comply with the need for weekly visits because of planned activity • Mental incapacity, unwillingness, 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of index ulcers completely healed after 20 weeks of intervention

Secondary endpoints 1

1. Change in ulcer area from time of randomization until after 20 weeks of intervention

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bispebjerg Hospital

Sponsor organisation

Bispebjerg Hospital

Address

Borgmester Ib Juuls Vej 31

City

Herlev

Postcode

2730

Country

Denmark

Scientific contact point

Organisation

Bispebjerg Hospital

Contact name

Ole Lander Svendsen

Public contact point

Organisation

Bispebjerg Hospital

Contact name

Ole Lander Svendsen

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications