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Completed

NCT Number: NCT05192707

Transcutaneous Oxygen Pressure (TcPO2) Determination.

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

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Key information

Conditions

Peripheral Arterial Diseases Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Médecine Interne - UF Explorations Fonctionnelles Vasculaires, Hôpital Edouard Herriot

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TcPO2 measurement on the upper limb

Diagnostic Test

Measurement of the transcutaneous Oxygen Pressure in the upper limb of 30 healthy volunteers and of at least 30 patients.

Primary outcomes

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

    Time frame: 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 outcomes

  1. TcPO2 of the upper limb (mmHg) (only for the healthy volunteers)

    Time frame: Enrollment

    average values of all TcPO2 values.

  2. ROC (Receiving Operator Characteristic) curve for critical ischemia (only for the retrospective patients)

    Time frame: 3 months

    critical ischemia is defined as an amputation more proximal than distal than the electrode or revascularization.

  3. Sensitivity and specificity for critical ischemia (only for the retrospective patients)

    Time frame: 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

  4. patients characteristics (only for the retrospective patients)

    Time frame: 3 months

    age, sex, vascular risk factors, etiology, medical treatment, other treatments).

  5. healing (only for the retrospective patients)

    Time frame: 3 months

    number and percentage of healing without amputation and without revascularization

  6. level of amputation (only for the retrospective patients)

    Time frame: 3 months

    number and percentage of patients with an amputation level more proximal that the electrodes

  7. revascularization (only for the retrospective patient)

    Time frame: 3 months

    number and percentage of revascularization procedures

  8. healing after revascularization

    Time frame: 3 months after revascularization

    percentage of healing following revascularization (only for the retrospective patient if data are available)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: TcP02

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 14, 2022
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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