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

Not Applicable

Completed

• Conditions: Compression; Vein; Leg Ulcer
• Interventions: Device: venous compression

• Registration Number: NCT03725111
• Lead Sponsor: University Hospital, Caen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-19
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-30
• Status Verified: 2018-11
• Study Start: 2018-12-30
• Primary Completion: 2018-12-31
• Study Completion: 2019-07-31
• Last Update Submitted: 2020-09-03
• Last Update Posted: 2020-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
arterio venous leg ulcers	venous compression	-

Primary Outcome Measures

Name	Time	Method
haemodynamic variation of the transcutaneous oxygen	1 month	measurement of the transcutaneous oxygen during two different appointement using a transcutaneous monitor TCM4

Trial Locations

Locations (1)

ELHOMSY; 🇫🇷 Caen, Basse Normandie, France