TcP02: Transcutaneous Oxygen Pressure (TcPO2) Determination.
Study Details
Study Description
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:
-
Prospective study of normal TcPO2 value in healthy volunteers
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Retrospective analysis of patients with upper limb arterial disease to approach the TcPO2 threshold of CLI allowing healing in upper limb
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Healthy Volunteers TcPO2 measurement in the upper limb of healthy volunteers |
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.
|
| 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) |
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.
|
Outcome Measures
Primary Outcome Measures
- TcPO2 of the upper limb (blood pressure, measured in millimeters of mercury (mmHg)). [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 Outcome Measures
- TcPO2 of the upper limb (mmHg) (only for the healthy volunteers) [Enrollment]
average values of all TcPO2 values.
- ROC (Receiving Operator Characteristic) curve for critical ischemia (only for the retrospective patients) [3 months]
critical ischemia is defined as an amputation more proximal than distal than the electrode or revascularization.
- Sensitivity and specificity for critical ischemia (only for the retrospective patients) [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
- patients characteristics (only for the retrospective patients) [3 months]
age, sex, vascular risk factors, etiology, medical treatment, other treatments).
- healing (only for the retrospective patients) [3 months]
number and percentage of healing without amputation and without revascularization
- level of amputation (only for the retrospective patients) [3 months]
number and percentage of patients with an amputation level more proximal that the electrodes
- revascularization (only for the retrospective patient) [3 months]
number and percentage of revascularization procedures
- healing after revascularization [3 months after revascularization]
percentage of healing following revascularization (only for the retrospective patient if data are available)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Service de Médecine Interne - UF Explorations Fonctionnelles Vasculaires, Hôpital Edouard Herriot | Lyon | France | 69003 |
Sponsors and Collaborators
- Hospices Civils de Lyon
Investigators
- Principal Investigator: Judith CATELLA, MD, Service de Médecine Interne - UF Explorations Fonctionnelles Vasculaires, HEH, HCL
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 69HCL21_0545