Anatomical Study of the Arteries of the Skin on Amputation Legs

Arteritic Leg Ulcer Clinical Trial

— APIA  

Official title:

Anatomical Study of the Arteries of the Skin on Amputation Legs

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03618615
• Other study ID #: 2017-A02936-47
• Status: Not yet recruiting
• Start date: September 30, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: September 2018
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteritic Leg Ulcer
• Leg Ulcer

Intervention

Biological:
• artericitc surgery
biological sample (leg) from leg amputation surgery used for research

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.