New Oxymetry Indices in Critical Limb Ischemia

NCT04209998 | Completed DMC

• 1 other identifier: 2019-A02619-48
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Transcutaneous oxygen tension (TcpO2) at rest, sensitized by oxygen inhalation tests, is widely applied for the evaluation of chronic critical limb ischemia (CLI). If foot TcpO2 measurements are good prognostic factors of the risk of amputation or the probability of wound healing without amputation, they have never proven their hability to estimate the risk of death in patients with critical limb ischemia. On the one hand, studies have considered only the response observed on legs without considered the thoracic variations. On the other hand, the variability of the TcpO2 signal has never been analyzed as a prognostic factor. The objective of the NOVICE study is therefore to assess, first, whether the variability of resting TcPO2 values at thoracic probe as well as at affected limb probe is a morbidity-mortality prognostic factor and secondly, to evaluate during the oxygen tests, if the measurement of the amplitude of the distal responses in ischemic zone compared to the response observed in thoracic probe is a prognostic factor of morbi-mortality.

Conditions

Critical Limb Ischemia

Keywords

transcutaneous oximetry; oxygen; peripheral artery disease; follow-up

Outcome Measures

Primary Outcomes (1)

• Mortality

  presence of MACE (major adverse cardiovascular event) following the oximetry test

  12 months

Secondary Outcomes (2)

• Morbidity

  12 moths

• Mortality (intermediate analysis)

  6 months minimal follow-up

Interventions

transcutaneous oximetry DIAGNOSTIC_TEST

Analysis of transcutaneous oximetry (Tcpo2) in terme of variability at rest and of response to oxygen inhalation

Also known as: oxygen inhalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for Tcpo2 recording for suspicion of critical limb ischemia.

You may qualify if:

• Suspicion of Critical limb ischemia
• Reffered for Tcpo2 Absence of rebuttal to the use of the data by the patients

You may not qualify if:

• No available tcpo2 recording
• Rejection of the follow up by the patients

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Centre hospitalier universitaire

Angers, 49933, France

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease

Interventions

Blood Gas Monitoring, Transcutaneous

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Oximetry; Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• ABRAHAM Pierre, MD PhD

  University Hospital in Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 24, 2019
• Study Start: January 16, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

FR (1)