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

ConditionFoot Ulcer Due to Type 2 Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-90
SponsorOle Lander Svendsen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Semaglutide, 1.34 mg/mL

    Drug

    pen for subcutaneous injections

  • Placebo

    Drug

    pen for subcutaneous injections

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: semaglutideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of clinical healed index foot ulcer at week 20

Difference between the groups treated with semalutide and with placeebo in proportion of index ulcers completely healed after 20 weeks of intervention. Assessment of complete ulcer healing by naked eye will be performed by trained study staff: Total closure/healed (total epithelization): Yes or No. Complete ulcer healing is defined (as by FDA) as complete skin re-epithelialization without drainage or dressing requirements, confirmed at two consecutive study visit two weeks apart, and the time encountered as healed is the first of the two visits.

Time frame
20 weeks

Secondary outcomes

1

Change in ulcer area after 20 weeks of intervention

Difference between the groups treated with semalutide and with placebo in change in ulcer area after 20 weeks of intervention. The index ulcers will be photographed using a standard camera. The distance from the ulcer will be appriximately 30 cm and a standard setting will be used for each photograph. A reference ruler will be included in the photograph and located beside the ulcer. The ulcer will be photographed 3 times and stored electronically. The ulcer area will be analyzed using ImageJ software v 1.47 (NIH).

Time frame
20 weeks
2

Change in ulcer area from time of randomization until 8 and 16 weeks of intervention

Difference between the groups treated with semalutide and with placebo in index ulcer area. The index ulcers will be photographed using a standard camera. The distance from the ulcer will be approximately 30 cm and a standard setting will be used for each photograph. A reference ruler will be included in the photograph and located beside the ulcer. The ulcer will be photographed 3 times and stored electronically. The ulcer area will be analyzed using ImageJ software v 1.47 (NIH).

Time frame
8 and 16 weeks
3

Change in distal blood pressure from time of randomization until after 20 weeks of intervention

Difference between the groups treated with semalutide and with placebo

Time frame
20 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ole Lander Svendsen

Lead sponsor

University Hospital Bispebjerg and Frederiksberg

Sponsor institution

Source ClinicalTrials.gov
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