Haemodynamics Variations of Transcutaneous Oxygen in Patient With Areterio-venous Leg Ulcers Under Venous Compression

February 13, 2026 updated by: University Hospital, Caen

Haemodynamics Variations of Transcutaneous Oxygen in Patient With Arterio-venous Leg Ulcers Under Venous Compression (COMPULCE Study)

Arterio-venous leg ulcers are real problems when it comes to public health because it has a major cost and leads to social and professional handicap.

The management of leg ulcers is not clear and can be venous compression or surgery.

The aim of the study is to evaluate the variation of the transcutaneous oxygen with compression.

The second aim is to see how tolerate is the compression and the quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Basse Normandie
      • Caen, Basse Normandie, France, 14000
        • ELHOMSY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age eighteen or more
  • leg arteio-venous ulcers

Exclusion Criteria:

  • age Under eighteen,
  • Index pressure in the ankle Under 0.5

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: arterio venous leg ulcers
Device: venous compression
venous compression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
haemodynamic variation of the transcutaneous oxygen
Time Frame: 1 month
measurement of the transcutaneous oxygen during two different appointement using a transcutaneous monitor TCM4
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

October 19, 2018

First Submitted That Met QC Criteria

October 29, 2018

First Posted (Actual)

October 30, 2018

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A01048-47

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Leg Ulcer

Clinical Trials on venous compression

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe