NCT03725111

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 30, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 30, 2018

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

February 17, 2026

Status Verified

November 1, 2018

Enrollment Period

1 day

First QC Date

October 19, 2018

Last Update Submit

February 13, 2026

Conditions

Leg UlcerCompression; Vein

Outcome Measures

Primary Outcomes (1)

  • haemodynamic variation of the transcutaneous oxygen

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

    1 month

Study Arms (1)

arterio venous leg ulcers

EXPERIMENTAL
Device: venous compression

Interventions

venous compressionDEVICE

venous compression

arterio venous leg ulcers

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • age eighteen or more
  • leg arteio-venous ulcers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ELHOMSY

Caen, Basse Normandie, 14000, France

Location

Related Publications (1)

  • Elhomsy S, Chrusciel J, Sanchez S, Elhomsy P, Guillaumat J. Clinical Efficacy and Safety of Long-Term Compression in Patients with Mixed Arterial and Venous Etiology Ulcers in the Leg. Int J Angiol. 2021 Aug 31;31(1):34-39. doi: 10.1055/s-0041-1735204. eCollection 2022 Mar.

    PMID: 35221850RESULT

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2018

First Posted

October 30, 2018

Study Start

December 30, 2018

Primary Completion

December 31, 2018

Study Completion

July 31, 2019

Last Updated

February 17, 2026

Record last verified: 2018-11

Locations

FR(1)