Transcutaneous Oxygen Pressure (TcPO2) Determination.

NCT05192707 | Recruiting

• 1 other identifier: 69HCL21_0545
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Prospective study of normal TcPO2 value in healthy volunteers
2. 2.Retrospective analysis of patients with upper limb arterial disease to approach the TcPO2 threshold of CLI allowing healing in upper limb

Conditions

Peripheral Arterial Diseases

Keywords

Transcutaneous Oxygen Pressure; Peripheral Arterial Disease; Chronic Limb ischemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• TcPO2 of the upper limb (mmHg) (only for the healthy volunteers)

  Enrollment

• ROC (Receiving Operator Characteristic) curve for critical ischemia (only for the retrospective patients)

  3 months

• Sensitivity and specificity for critical ischemia (only for the retrospective patients)

  3 months

• patients characteristics (only for the retrospective patients)

  3 months

• healing (only for the retrospective patients)

  3 months

Study Arms (2)

Healthy Volunteers

TcPO2 measurement in the upper limb of healthy volunteers

Diagnostic Test: TcPO2 measurement on the upper limb

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

Interventions

TcPO2 measurement on the upper limb DIAGNOSTIC_TEST

Measurement of the transcutaneous Oxygen Pressure in the upper limb of 30 healthy volunteers and of at least 30 patients.

Healthy Volunteers; Patients with arterial disease in the upper limb and wound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• under 18 yrs old
• under law protection
• pregnancy
• Retrospective patients part:
• 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
• under 18 yrs old
• under law protection
• pregnancy

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de Médecine Interne - UF Explorations Fonctionnelles Vasculaires, Hôpital Edouard Herriot

Lyon, Lyon, 69003, France

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Judith CATELLA, MD

  Service de Médecine Interne - UF Explorations Fonctionnelles Vasculaires, HEH, HCL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith CATELLA, MD

CONTACT

+33 472 11 77 91; Judith.catella@chu-lyon.fr

Evelyne DECULLIER, MD

CONTACT

04 72 11 57 06; evelyne.decullier@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 14, 2022
• Study Start: March 1, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

FR (1)