Peripheral Arterial DiseasesTcP02NCT05192707
Transcutaneous Oxygen Pressure (TcPO2) Determination.
An observational study of Peripheral Arterial Diseases, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Diseases
- What is being tested?
- TcPO2 measurement on the upper limb
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2022to 22 Jul 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- healthy volunteer without upper limb arterial disease
- absence of opposition
- affiliated to social insurance
- 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
Who cannot join
- under 18 yrs old
- under law protection
- pregnancy
- Retrospective patients part:
- under 18 yrs old
- under law protection
- pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Interne - UF Explorations Fonctionnelles Vasculaires, Hôpital Edouard Herriot
Lyon, Lyon, 69003
About this study
Official title: Standardized Transcutaneous Oxygen Pressure Determination in the Upper Limb: Normal Value and Chronic Limb Ischemia
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.
Read more
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:
- Prospective study of normal TcPO2 value in healthy volunteers
- Retrospective analysis of patients with upper limb arterial disease to approach the TcPO2 threshold of CLI allowing healing in upper limb
- Conditions
- Peripheral Arterial Diseases
- Being tested
- TcPO2 measurement on the upper limb
- Keywords
- Transcutaneous Oxygen Pressure, Peripheral Arterial Disease, Chronic Limb ischemia
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TcPO2 measurement on the upper limbDiagnostic test
Measurement of the transcutaneous Oxygen Pressure in the upper limb of 30 healthy volunteers and of at least 30 patients.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | TcPO2 measurement in the upper limb of healthy volunteers Receives: Diagnostic Test: TcPO2 measurement on the upper limb | |
| Patients with arterial disease in the upper limb and wound | Patients with arterial disease in the upper limb and wound (retrospective setting, research on data) Receives: Diagnostic Test: TcPO2 measurement on the upper limb |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Healthy volunteers: Enrollment. Patients: 1 month after information letter sending.
Secondary outcomes (8)
TcPO2 of the upper limb (mmHg) (only for the healthy volunteers)
average values of all TcPO2 values.
Measured: Enrollment
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.
Measured: 3 months
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
Measured: 3 months
patients characteristics (only for the retrospective patients)
age, sex, vascular risk factors, etiology, medical treatment, other treatments).
Measured: 3 months
healing (only for the retrospective patients)
number and percentage of healing without amputation and without revascularization
Measured: 3 months
level of amputation (only for the retrospective patients)
number and percentage of patients with an amputation level more proximal that the electrodes
Measured: 3 months
revascularization (only for the retrospective patient)
number and percentage of revascularization procedures
Measured: 3 months
healing after revascularization
percentage of healing following revascularization (only for the retrospective patient if data are available)
Measured: 3 months after revascularization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start1 Mar 2022
- Primary completion22 Jul 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseasesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith CATELLA, MD, Principal investigator, Service de Médecine Interne - UF Explorations Fonctionnelles Vasculaires, HEH, HCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192707
- Sponsor's protocol ID
- 69HCL21_0545
- Acronym
- TcP02
- Status last verified
- May 2026
- First submitted
- 2 Dec 2021
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided