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

NCT05099367 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-12-06

No results posted yet for this study

Summary

Prospective, monocentric, pathophysiological study, comparing 3 parallel groups: healthy controls; patients with diabetes and without DFU; patients with diabetes and with DFU. To address secondary objectives, samples from a fourth group will be collected.

Conditions

  • Diabetes Mellitus, Type 2
  • Diabetic 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.

Sponsors & Collaborators

  • National Research Agency, France

    collaborator OTHER

  • University Hospital, Grenoble

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2025-02-28
Completion
2025-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05099367 on ClinicalTrials.gov