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

Primary Purpose

Leg Ulcer, Compression; Vein

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
venous compression
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leg Ulcer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age eighteen or more
  • leg arteio-venous ulcers

Exclusion Criteria:

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

Sites / Locations

  • ELHOMSY

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

arterio venous leg ulcers

Arm Description

Outcomes

Primary Outcome Measures

haemodynamic variation of the transcutaneous oxygen
measurement of the transcutaneous oxygen during two different appointement using a transcutaneous monitor TCM4

Secondary Outcome Measures

Full Information

First Posted
October 19, 2018
Last Updated
September 3, 2020
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT03725111
Brief Title
Haemodynamics Variations of Transcutaneous Oxygen in Patient With Areterio-venous Leg Ulcers Under Venous Compression
Official Title
Haemodynamics Variations of Transcutaneous Oxygen in Patient With Arterio-venous Leg Ulcers Under Venous Compression (COMPULCE Study)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 30, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Ulcer, Compression; Vein

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
arterio venous leg ulcers
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
venous compression
Intervention Description
venous compression
Primary Outcome Measure Information:
Title
haemodynamic variation of the transcutaneous oxygen
Description
measurement of the transcutaneous oxygen during two different appointement using a transcutaneous monitor TCM4
Time Frame
1 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age eighteen or more leg arteio-venous ulcers Exclusion Criteria: age Under eighteen, Index pressure in the ankle Under 0.5
Facility Information:
Facility Name
ELHOMSY
City
Caen
State/Province
Basse Normandie
ZIP/Postal Code
14000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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