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RecruitingNCT05192707

Transcutaneous Oxygen Pressure (TcPO2) Determination.

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
60 (estimated)
Sponsor
Hospices Civils de Lyon · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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. 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

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTTcPO2 measurement on the upper limbMeasurement of the transcutaneous Oxygen Pressure in the upper limb of 30 healthy volunteers and of at least 30 patients.

Timeline

Start date
2022-03-01
Primary completion
2026-09-01
Completion
2026-09-01
First posted
2022-01-14
Last updated
2025-10-02

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05192707. Inclusion in this directory is not an endorsement.