WoundTOXIPONCT03608384
Characteristic of Drug Users Chronic Wound
An observational study of Wound and Drug Use, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The aim of this study is to describe demographic, clinical, etiological characteristic and evolution of drug addict's chronic wounds . Read more about this study
- Who is it for?
- Any age
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2018to 5 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Drug addict are mainly young man, use intravenous drug ( opioid, cocaine) and inhaled drug ( cannabis).
Who may be able to join
- all drug addict with chronic wound ( evolving at least since 1 month)
Who cannot join
- use following medication inductor of cutaneous ulcer: hydroxycarbamide, gefitinib, cetuximab, sunitinib, sorafenib, pazopanib, gemcitabine, sirolimus, methotrexate, nicorandil .
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to describe demographic, clinical, etiological characteristic and evolution of drug addict's chronic wounds .
- Medical subject headings
- Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical venous insufficiency - presence of oedema
presence of oedema
Measured: at inclusion
Secondary outcomes (3)
clinical venous insufficiency - presence of varicose
presence of varicose
Measured: at inclusion
clinical venous insufficiency - presence of white atrophy
presence of white atrophy
Measured: at inclusion
clinical venous insufficiency - presence of varicose eczema
presence of varicose eczema
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start1 Aug 2018
- Primary completion5 Feb 2019
- Study completion5 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc Schmutz, Study director, CHRU Vandoeuvre-Lès-Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608384
- Sponsor's protocol ID
- PSS/TOXIPO-SCHMUTZ/ELR
- Acronym
- TOXIPO
- Status last verified
- Apr 2019
- First submitted
- 24 Jul 2018
- Last updated
- 12 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristic of Drug Users Chronic Wound
- ClinicalTrials.gov ID
- NCT03608384
- Acronym / sponsor ID
- TOXIPO / PSS/TOXIPO-SCHMUTZ/ELR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 5 Feb 2019 (actual)
- Study completion
- 5 Feb 2019 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to describe demographic, clinical, etiological characteristic and evolution of drug addict's chronic wounds .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Drug addict are mainly young man, use intravenous drug ( opioid, cocaine) and inhaled drug ( cannabis).
Key inclusion criteria (1 listed)
- all drug addict with chronic wound ( evolving at least since 1 month)
Key exclusion criteria (1 listed)
- use following medication inductor of cutaneous ulcer: hydroxycarbamide, gefitinib, cetuximab, sunitinib, sorafenib, pazopanib, gemcitabine, sirolimus, methotrexate, nicorandil .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
clinical venous insufficiency - presence of oedema
Time frame: at inclusion
presence of oedema
3 secondary outcomes
clinical venous insufficiency - presence of varicose
Time frame: at inclusion
clinical venous insufficiency - presence of white atrophy
Time frame: at inclusion
clinical venous insufficiency - presence of varicose eczema
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Wound
Not yet recruitingObservational study
Results of Medical and Nursing Record,PE, Blood Test and Radiological Examination ,Morality and Mobility of Multiple Trauma of Patient's
Trauma Centers/Statistics & Numerical Data, Trauma Blunt
Enrolling by invitation
MIO-CPP to Improve the Well-being, Permanency, and Safety Outcomes for Young Children at Risk of or in Out-of-home Placement in Philadelphia and Bucks Counties, and Affected by Maternal Substance Use
Substance Use Disorders, Parent-Child Relations
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veterans
Alcohol Problems, Post-Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Luc Schmutz study director
CHRU Vandoeuvre-Lès-Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound and Drug Use, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical venous insufficiency - presence of oedema (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.