Transcutaneous Oxygen Pressure (TcPO2) Determination.

Recruiting

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. 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

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Retrospective patients part:

Inclusion Criteria:

Exclusion Criteria:

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	TcPO2 measurement on the upper limb	TcPO2 measurement in the upper limb of healthy volunteers
Patients with arterial disease in the upper limb and wound	TcPO2 measurement on the upper limb	Patients with arterial disease in the upper limb and wound (retrospective setting, research on data)

Primary Outcome Measures

Name	Time	Method
TcPO2 of the upper limb (blood pressure, measured in millimeters of mercury (mmHg)).	Healthy volunteers: Enrollment. Patients: 1 month after information letter sending.	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.

Secondary Outcome Measures

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

Locations (1): Service de Médecine Interne - UF Explorations Fonctionnelles Vasculaires, Hôpital Edouard Herriot
🇫🇷
Lyon, France