Transcutaneous Oxygen Pressure (TcPO2) Determination.

Peripheral Arterial Diseases Clinical Trial

— TcP02  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05192707
• Other study ID #: 69HCL21_0545
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2023
• Source: Hospices Civils de Lyon
• Contact: Judith CATELLA, MD
• Phone: +33 472 11 77 91
• Email: Judith.catella[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Arterial Diseases
• Peripheral Vascular Diseases

Intervention

Diagnostic Test:
• TcPO2 measurement on the upper limb
Measurement of the transcutaneous Oxygen Pressure in the upper limb of 30 healthy volunteers and of at least 30 patients.

Locations

Country	Name	City	State
France	Service de Médecine Interne - UF Explorations Fonctionnelles Vasculaires, Hôpital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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