Characteristic of Drug Users Chronic Wound | NCT03608384

Studies
Characteristic of Drug Users Chronic Wound

NCT03608384

Sponsor

Central Hospital, Nancy, France

Status

Completed

Last Update Posted

Apr 12, 2019Actual

Enrollment

58Actual

Phase

Not provided

Conditions

Wound
Drug Use

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2018Actual

Primary Completion Date

Feb 5, 2019Actual

Completion Date

Feb 5, 2019Actual

First Submitted Date

Jul 24, 2018

First Submission Date that Met QC Criteria

Jul 30, 2018

First Posted Date

Jul 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2019

Last Update Posted Date

Apr 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to describe demographic, clinical, etiological characteristic and evolution of drug addict's chronic wounds .

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 .

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Luc Schmutz	CHRU Vandoeuvre-Lès-Nancy	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU De Nancy		Vandœuvre-lès-Nancy		54500	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided