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
-
-
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
|
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
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.
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.