Arteritic Leg UlcerAPIANCT03618615
Anatomical Study of the Arteries of the Skin on Amputation Legs
An observational study of Arteritic Leg Ulcer, run by Central Hospital, Nancy, France.
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). Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Arteritic Leg Ulcer
- What is being tested?
- artericitc surgery
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2018to 30 Sep 2021
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: arteritic patient coming to CHRUN as part of the care
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
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).
Read the 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.
- Conditions
- Arteritic Leg Ulcer
- Being tested
- artericitc surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artericitc surgeryBiological
biological sample (leg) from leg amputation surgery used for research
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours after the dissection of the leg.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start30 Sep 2018 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteritic Leg UlcerStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618615
- Sponsor's protocol ID
- 2017-A02936-47
- Acronym
- APIA
- Status last verified
- Sep 2018
- First submitted
- 1 Aug 2018
- Last updated
- 12 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Study of the Arteries of the Skin on Amputation Legs
- ClinicalTrials.gov ID
- NCT03618615
- Acronym / sponsor ID
- APIA / 2017-A02936-47
- Conditions
- Arteritic Leg Ulcer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 30 Sep 2018 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 7 Aug 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- arteritic patient coming to CHRUN as part of the care
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| artericitc surgerybiological sample (leg) from leg amputation surgery used for research | Biological | – |
Primary outcome
Qualitative mapping of the skin's arteries.
Time frame: 72 hours after the dissection of the leg.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteritic Leg Ulcer, run by Central Hospital, Nancy, 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Qualitative mapping of the skin's arteries. (time frame: 72 hours after the dissection of the leg.). 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 Sep 2018.