Clinical trial NCT05192707: Transcutaneous Oxygen Pressure (TcPO2) Determination.
Official title: Standardized Transcutaneous Oxygen Pressure Determination in the Upper Limb: Normal Value and Chronic Limb Ischemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Arterial Diseases
Keywords: Transcutaneous Oxygen Pressure
Peripheral Arterial Disease
Chronic Limb ischemia
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
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).

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


Eligibility 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

Primary outcomes:
measure: TcPO2 of the upper limb (blood pressure, measured in millimeters of mercury (mmHg)).
timeFrame: Healthy volunteers: Enrollment. Patients: 1 month after information letter sending.
Secondary outcomes:
measure: TcPO2 of the upper limb (mmHg) (only for the healthy volunteers)
timeFrame: Enrollment
measure: ROC (Receiving Operator Characteristic) curve for critical ischemia (only for the retrospective patients)
timeFrame: 3 months
measure: Sensitivity and specificity for critical ischemia (only for the retrospective patients)
timeFrame: 3 months
measure: patients characteristics (only for the retrospective patients)
timeFrame: 3 months
measure: healing (only for the retrospective patients)
timeFrame: 3 months
measure: level of amputation (only for the retrospective patients)
timeFrame: 3 months
measure: revascularization (only for the retrospective patient)
timeFrame: 3 months
measure: healing after revascularization
timeFrame: 3 months after revascularization
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Médecine Interne - UF Explorations Fonctionnelles Vasculaires, Hôpital Edouard Herriot
Study officials:
affiliation: Service de Médecine Interne - UF Explorations Fonctionnelles Vasculaires, HEH, HCL
name: Judith CATELLA, MD
role: PRINCIPAL_INVESTIGATOR
References: