Anatomical Study of the Arteries of the Skin on Amputation Legs (APIA)

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).

Study Overview

• Status: Unknown
• Conditions: Arteritic Leg Ulcer
• Intervention / Treatment: Biological: artericitc surgery

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

arteritic patient coming to CHRUN as part of the care

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Anticipated): September 30, 2018
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 7, 2018

Study Record Updates

• Last Update Posted (Actual): September 12, 2018
• Last Update Submitted That Met QC Criteria: September 11, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Leg Ulcer
• Other Study ID Numbers: 2017-A02936-47

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No