Anatomical Study of the Arteries of the Skin on Amputatio... | NCT03618615

Studies
Anatomical Study of the Arteries of the Skin on Amputation Legs

NCT03618615

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Sep 12, 2018Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Arteritic Leg Ulcer

Interventions

artericitc surgery

Countries

Not provided

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

Sep 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2018Estimated

Primary Completion Date

Sep 30, 2021Estimated

Completion Date

Sep 30, 2021Estimated

First Submitted Date

Aug 1, 2018

First Submission Date that Met QC Criteria

Aug 1, 2018

First Posted Date

Aug 7, 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

Sep 11, 2018

Last Update Posted Date

Sep 12, 2018Actual

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

PRIMARY OBJECTIVE Qualitatively describe the distribution of cutaneous arteries in patients with long-term occlusive arterial disease.

SECONDARY OBJECTIVE To compare the distribution of cutaneous arteries observed on the legs of arteritic patients with that observed on non-arteritic legs (from bodies given to science).

Detailed Description

Arterial patient coming to CHRU Nancy, in the Vascular and Endoluminal Surgery Department, to undergo leg amputation.

Usually, after the amputation of the leg in the operating theatre, the surgical waste is destroyed.

Instead of being destroyed, the leg will be used for research.

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

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
artericitc surgery	Biological	biological sample (leg) from leg amputation surgery used for research

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Qualitative mapping of the skin's arteries.	The leg will be transported in a container to the Anatomy Laboratory (Faculty of Medicine - University of Lorraine). Within 72 hours of its arrival, the operating room will be dissected to qualitatively describe the distribution of cutaneous arteries in patients with long-term occlusive arterial disease.	72 hours after the dissection of the leg.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Major Patient
Patient with late stage occlusive arteriopathy with lower limb amputation
Patient who did not oppose the search
Patient affiliated to a social security scheme

Exclusion Criteria:

Patients with infectious diseases not accessible in the anatomy laboratory
Woman of childbearing age without effective contraception
Persons referred to in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the Public Health Code :
Pregnant woman, parturient or nursing mother
Person deprived of liberty by a judicial or administrative decision,
Person under psychiatric care pursuant to Articles L.3212-1 and L.3213-1 of the Public Health Code
Person admitted to a health or social institution for purposes other than research
Minor person (not emancipated)
Adult subject to a legal protection measure (guardianship, trusteeship, protection of justice)
Major person who is not in a position to express consent and who is not subject to a legal protection measure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

arteritic patient coming to CHRUN as part of the care

Sampling Method

Probability Sample

Description

Arterial patient coming to CHRU Nancy, in the Vascular and Endoluminal Surgery Department, to undergo leg amputation.

Usually, after the amputation of the leg in the operating theatre, the surgical waste is destroyed.

Instead of being destroyed, the leg will be used for research.