Transcutaneous Oxygen Pressure (TcPO2) Determination. (TcP02)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Peripheral Arterial Diseases

Treatments: Diagnostic Test: TcPO2 measurement on the upper limb

Study type: Observational

Funder types: Other

Identifiers

NCT05192707

69HCL21_0545

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

60 participants in 2 patient groups

Healthy Volunteers

Description:

TcPO2 measurement in the upper limb of healthy volunteers

Treatment:

Diagnostic Test: TcPO2 measurement on the upper limb

Patients with arterial disease in the upper limb and wound

Description:

Patients with arterial disease in the upper limb and wound (retrospective setting, research on data)

Treatment:

Diagnostic Test: TcPO2 measurement on the upper limb