Healing Diabetic Foot Ulcers with Semaglutide

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Radboud universitair medisch centrum Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2026-03-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novo Nordisk

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To demonstrate the effect of semaglutide on the time to wound closure in patients with a diabetic foot wound.

Secondary objectives 6

1. To demonstrate that semaglutide increases the proportion of patients that meet the guideline criterium of >50% reduction in ulcer surface area after 6 weeks of treatment compared to usual care
2. To demonstrate that semaglutide reduces ulcer surface area and/or ulcer depth over time compared to usual care
3. To demonstrate that semaglutide improves limb vascular status compared to usual care
4. To demonstrate that semaglutide reduces the amputation rate compared to usual care
5. To demonstrate that semaglutide reduces the rate of (endo)vascular interventions compared to usual care
6. To demonstrate that semaglutide lowers infection rate compared to usual care

Conditions and MedDRA coding

Diabetic foot ulcer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Have type 2 diabetes mellitus (T2DM)
2. Presence of an active diabetic foot ulcer
3. Age >18 years
4. Be proficient in either Dutch or English

Exclusion criteria 7

1. Those with current use or who used a GLP-1RA or GLP-1/GIP co-agonist in the previous 6 months.
2. Any contra-indication for semaglutide as outlined in the EPAR (which only consists of allergy to the contents of semaglutide injections)
3. Current pregnancy
4. Previous pancreatitis attributed to use of GLP-1RA
5. End-stage renal disease (defined as estimated-GFR <15 mL/min/m2 or the use of renal replacement therapy)
6. Current use of anti-inflammatory therapy, e.g. prednisolone
7. Life expectancy <3 months

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Time (in weeks) to wound closure in patients with a DFU using semaglutide versus standard of care treatment.

Secondary endpoints 6

1. Rate of >50% reduction in ulcer surface area after 6 week of treatment between study groups (excluding newly formed ulcers)
2. Ulcer surface area and depth at every outpatient clinic (relative to baseline)
3. The change in ankle-brachial index/toe pressure measurements over time (at inclusion, and after wound closure of 6 months of follow-up)
4. Rate of lower limb amputation
5. Rate of endovascular intervention in lower extremities
6. Rate of infection

Investigational products

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

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Radboud universitair medisch centrum Stichting

Sponsor organisation

Radboud universitair medisch centrum Stichting

Address

Geert Grooteplein Zuid 10

City

Nijmegen

Postcode

6525 GA

Country

Netherlands

Scientific contact point

Organisation

Radboud universitair medisch centrum Stichting

Contact name

Teba Alnima

Public contact point

Organisation

Radboud universitair medisch centrum Stichting

Contact name

Teba Alnima

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

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

Documents 6 files

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

Application history

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