Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2022-03-01
2026-09-30
Brief Summary
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In the upper limb, there is no guideline to define CLI. When there is a wound preventing finger pressure measurement, TcPO2 is theoretically indicated. However, there is neither standardized site to measure nor threshold value of TcPO2.
The investigators hypothesized that normal TcPO2 may be different in the upper limb and that threshold value for CLI may also be different compared to lower limb.
The investigators planned a study with two parts:
1. Prospective study of normal TcPO2 value in healthy volunteers
2. Retrospective analysis of patients with upper limb arterial disease to approach the TcPO2 threshold of CLI allowing healing in upper limb
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Healthy Volunteers
TcPO2 measurement in the upper limb of healthy volunteers
TcPO2 measurement on the upper limb
Measurement of the transcutaneous Oxygen Pressure in the upper limb of 30 healthy volunteers and of at least 30 patients.
Patients with arterial disease in the upper limb and wound
Patients with arterial disease in the upper limb and wound (retrospective setting, research on data)
TcPO2 measurement on the upper limb
Measurement of the transcutaneous Oxygen Pressure in the upper limb of 30 healthy volunteers and of at least 30 patients.
Interventions
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TcPO2 measurement on the upper limb
Measurement of the transcutaneous Oxygen Pressure in the upper limb of 30 healthy volunteers and of at least 30 patients.
Eligibility Criteria
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Inclusion Criteria
* absence of opposition
* affiliated to social insurance
* patients with a TCPO2 measurement available for the upper limb
* patients with a follow-up of at least 3 months available
* absence of opposition
* affiliated to social insurance
Exclusion Criteria
* under law protection
* pregnancy
Retrospective patients part:
* under 18 yrs old
* under law protection
* pregnancy
18 Years
ALL
Yes
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Judith CATELLA, MD
Role: PRINCIPAL_INVESTIGATOR
Service de Médecine Interne - UF Explorations Fonctionnelles Vasculaires, HEH, HCL
Locations
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Service de Médecine Interne - UF Explorations Fonctionnelles Vasculaires, Hôpital Edouard Herriot
Lyon, Lyon, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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69HCL21_0545
Identifier Type: -
Identifier Source: org_study_id
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