Transcutaneous Oxygen Pressure (TcPO2) Determination. (TcP02)

Standardized Transcutaneous Oxygen Pressure Determination in the Upper Limb: Normal Value and Chronic Limb Ischemia

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

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Diseases
• Intervention / Treatment: Diagnostic test: TcPO2 measurement on the upper limb

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• France
  • Lyon
    • Lyon, Lyon, France, 69003
      • Service de Médecine Interne - UF Explorations Fonctionnelles Vasculaires, Hôpital Edouard Herriot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population will be made of :

1. healthy volunteers,
2. and patients with upper limb arterial disease followed in the "Explorations Fonctionnelles Vasculaires" Unit of the "Médecine Interne" department of Edouard Herriot hospital (HCL, Lyon).

Description

Healthy volunteers part:

Inclusion Criteria:

• healthy volunteer without upper limb arterial disease
• absence of opposition
• affiliated to social insurance

Exclusion Criteria:

• under 18 yrs old
• under law protection
• pregnancy

Retrospective patients part:

Inclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Volunteers; TcPO2 measurement in the upper limb of healthy volunteers	Diagnostic test: 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)	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TcPO2 of the upper limb (blood pressure, measured in millimeters of mercury (mmHg)).	Measured on both healthy volunteers (4 sites of measure) and patients with arterial disease The measurements are carried out by non-invasive extracorporeal electrodes with CE (Conformité Européenne) marked equipment and used in accordance with the CE mark.	Healthy volunteers: Enrollment. Patients: 1 month after information letter sending.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TcPO2 of the upper limb (mmHg) (only for the healthy volunteers)	average values of all TcPO2 values.	Enrollment
ROC (Receiving Operator Characteristic) curve for critical ischemia (only for the retrospective patients)	critical ischemia is defined as an amputation more proximal than distal than the electrode or revascularization.	3 months
Sensitivity and specificity for critical ischemia (only for the retrospective patients)	critical ischemia is defined as an amputation more proximal than distal than the electrode or revascularization. Tested threshold: 30mmHg, 30 mmHg, 40mmHg, 50mmHg and 60mmHg	3 months
patients characteristics (only for the retrospective patients)	age, sex, vascular risk factors, etiology, medical treatment, other treatments).	3 months
healing (only for the retrospective patients)	number and percentage of healing without amputation and without revascularization	3 months
level of amputation (only for the retrospective patients)	number and percentage of patients with an amputation level more proximal that the electrodes	3 months
revascularization (only for the retrospective patient)	number and percentage of revascularization procedures	3 months
healing after revascularization	percentage of healing following revascularization (only for the retrospective patient if data are available)	3 months after revascularization

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Judith CATELLA, MD, Service de Médecine Interne - UF Explorations Fonctionnelles Vasculaires, HEH, HCL

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): July 22, 2025
• Study Completion (Actual): July 22, 2025

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Peripheral Arterial Disease; Transcutaneous Oxygen Pressure; Chronic Limb ischemia
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 69HCL21_0545

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No