Transcutaneous Oxygen Pressure (TcPO2) Determination.

NCT ID: NCT05192707

Last Updated: 2025-10-02

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2026-09-30

Brief Summary

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Upper limb arterial disease is a rare condition compared to lower limb arterial disease. In the lower limb, chronic limb ischemia (CLI) is characterized by an intractable pain or an ulceration present for at least 2 weeks. Guidelines recommend to use Transcutaneous Oxygen pressure (TcPO2) measurement when a CLI is suspected to establish diagnostic with a threshold of 30 mmHg when ankle and toe systolic pressure are not available.

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

Detailed Description

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Conditions

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Peripheral Arterial Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Healthy Volunteers

TcPO2 measurement in the upper limb of healthy volunteers

TcPO2 measurement on the upper limb

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* healthy volunteer without upper limb arterial disease
* 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 18 yrs old
* under law protection
* pregnancy

Retrospective patients part:


* under 18 yrs old
* under law protection
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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France

Central Contacts

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Judith CATELLA, MD

Role: CONTACT

+33 472 11 77 91

Evelyne DECULLIER, MD

Role: CONTACT

04 72 11 57 06

Facility Contacts

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Judith CATELLA, MD

Role: primary

04.72.11.77.91 ext. +33

Other Identifiers

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69HCL21_0545

Identifier Type: -

Identifier Source: org_study_id

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