Prostacyclin (PGI2) Pathway to Enhance Wound Healing in Diabetic Foot Ulcers

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

October 1, 2021

Primary Completion Date

February 28, 2025

Study Completion Date

August 31, 2025

Conditions
Diabetes Mellitus, Type 2Diabetic Foot
Interventions
DIAGNOSTIC_TEST

Microdialysis, current induced vasodilation

"CIV will be applied over all microdialysis fibers: one perfused with saline, one perfused with a preferential COX-1 blocker; and one perfused with a preferential COX-2 blocker.~CIV will be applied over all fibers in the following conditions: one perfused with saline, one perfused with fluconazole and L-NMMA, and the last one perfused with lidocaine.Dialysate collection will be performed after each CIV: dermal PGI2 metabolite (6-ketoPGF1α) and other COX-dependent prostanoids or metabolite (e.g. 11-dehydroTXB2) will be collected in the dialysate fluid and quantified. One hour after the last condition, treprostinil will be perfused over all fibers."

DIAGNOSTIC_TEST

Skin biopsy

Skin biopsy will be proposed. It will be performed on the internal superior calf (medial gastrocnemius), at a reasonable distance from the foot

DIAGNOSTIC_TEST

peri-ulcerated skin biopsy

Non-ulcerated skin from the peri-wound area will be collected. These patient will not undergo all the procedures included in this protocol.

Trial Locations (1)

38000

RECRUITING

CHU Grenoble Alpes Centre d'investigation clinique, Grenoble

All Listed Sponsors
lead

University Hospital, Grenoble

OTHER

collaborator

National Research Agency, France

OTHER