Measuring oxygen levels in the upper limb for arterial disease diagnosis
Standardized Transcutaneous Oxygen Pressure Determination in the Upper Limb: Normal Value and Chronic Limb Ischemia
Hospices Civils de Lyon · NCT05192707
This study is trying to find out normal oxygen levels in healthy people and compare them to those with upper limb arterial disease to help improve how we diagnose this condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon (other) |
| Locations | 1 site (Lyon) |
| Trial ID | NCT05192707 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine the normal transcutaneous oxygen pressure (TcPO2) values in healthy volunteers and analyze TcPO2 measurements in patients with upper limb arterial disease. The study is divided into two parts: a prospective evaluation of TcPO2 in healthy individuals and a retrospective analysis of patients with existing TcPO2 data. The goal is to establish a standardized measurement site and threshold values for diagnosing chronic limb ischemia (CLI) in the upper limb, which currently lacks established guidelines.
Who should consider this trial
Good fit: Ideal candidates include healthy volunteers without upper limb arterial disease and patients with available TcPO2 measurements for the upper limb.
Not a fit: Patients under 18 years old, pregnant women, or those under legal protection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical diagnostic criteria for upper limb arterial diseases, improving patient outcomes.
How similar studies have performed: While studies on TcPO2 in lower limbs have shown success, this approach for the upper limb is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lyon
- Service de Médecine Interne - UF Explorations Fonctionnelles Vasculaires, Hôpital Edouard Herriot — Lyon, France (RECRUITING)
Study contacts
- Principal investigator: Judith CATELLA, MD — Service de Médecine Interne - UF Explorations Fonctionnelles Vasculaires, HEH, HCL
- Study coordinator: Judith CATELLA, MD
- Email: Judith.catella@chu-lyon.fr
- Phone: +33 472 11 77 91
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheral Arterial Diseases, Transcutaneous Oxygen Pressure, Peripheral Arterial Disease, Chronic Limb ischemia