CompletedNot Applicable

Transcutaneous Oxygen Pressure (TcPO2) Determination.

France39 participantsStarted 2022-03-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

TcPO2 of the upper limb (blood pressure, measured in millimeters of mercury (mmHg)).

Timeframe: Healthy volunteers: Enrollment. Patients: 1 month after information letter sending.

Trial details

NCT IDNCT05192707

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07-22

View on ClinicalTrials.gov More Peripheral Arterial Diseases trials