Characteristic of Drug Users Chronic Wound (TOXIPO)

April 10, 2019 updated by: Central Hospital, Nancy, France
The aim of this study is to describe demographic, clinical, etiological characteristic and evolution of drug addict's chronic wounds .

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

58

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

  • France
      • Vandoeuvre Les Nancy, France, 54500
        • CHRU de Nancy

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

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Drug addict are mainly young man, use intravenous drug ( opioid, cocaine) and inhaled drug ( cannabis).

Description

Inclusion Criteria:

  • all drug addict with chronic wound ( evolving at least since 1 month)

Exclusion Criteria:

  • use following medication inductor of cutaneous ulcer: hydroxycarbamide, gefitinib, cetuximab, sunitinib, sorafenib, pazopanib, gemcitabine, sirolimus, methotrexate, nicorandil .

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical venous insufficiency - presence of oedema
Time Frame: at inclusion
presence of oedema
at inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical venous insufficiency - presence of varicose
Time Frame: at inclusion
presence of varicose
at inclusion
clinical venous insufficiency - presence of white atrophy
Time Frame: at inclusion
presence of white atrophy
at inclusion
clinical venous insufficiency - presence of varicose eczema
Time Frame: at inclusion
presence of varicose eczema
at inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Study Director: Jean-Luc Schmutz, CHRU Vandoeuvre-Lès-Nancy

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)

August 1, 2018

Primary Completion (Actual)

February 5, 2019

Study Completion (Actual)

February 5, 2019

Study Registration Dates

First Submitted

July 24, 2018

First Submitted That Met QC Criteria

July 30, 2018

First Posted (Actual)

July 31, 2018

Study Record Updates

Last Update Posted (Actual)

April 12, 2019

Last Update Submitted That Met QC Criteria

April 10, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSS/TOXIPO-SCHMUTZ/ELR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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