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NCT03725111 Clinical Trial

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

Leg Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03725111
Other study ID # 2018-A01048-47
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 30, 2018
Est. completion date July 31, 2019

Study information
Verified date November 2018
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date July 31, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- age eighteen or more

- leg arteio-venous ulcers

Exclusion Criteria:

- age Under eighteen,

- Index pressure in the ankle Under 0.5

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• venous compression
venous compression

Locations
Country Name City State
France ELHOMSY Caen Basse Normandie

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary haemodynamic variation of the transcutaneous oxygen measurement of the transcutaneous oxygen during two different appointement using a transcutaneous monitor TCM4 1 month
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