New Oxymetry Indices in Critical Limb Ischemia

Critical Limb Ischemia Clinical Trial

— NOVICE  

Official title:

New Oxymetry Indices in Critical Limb Ischemia (French Original Title is "Nouveaux Indices Oxymétriques Chez Les Patients Vus Pour Suspicion d'Ischémie Critique du membrE inférieur")

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04209998
• Other study ID #: 2019-A02619-48
• Status: Completed
• Start date: January 16, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: June 2022
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is an ambispective (both retrospective and prospective) cohort study in which any major patient, referred for resting (transcutyaneous oxygen pressure = TcpO2) for suspicion of critical limb ischemia, is included retrospectively and prospectively from November 2018 to October 2020. Tcpo2 recording are analysed to determine specific parameters (signal variability and response top oxygen). A morbidity-mortality follow-up is carried out between 12 and 15 months after the Tcpo2 measurement. A Kaplan Mayer study of these indices against MALE (major adverse lower limb events ) and MACE(Major adverse cardiovascular events) will be carried out.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Suspicion of Critical limb ischemia

• Reffered for Tcpo2 Absence of rebuttal to the use of the data by the patients

Exclusion Criteria:

• No available tcpo2 recording

• Rejection of the follow up by the patients

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia

Intervention

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

Locations

Country	Name	City	State
France	Centre hospitalier universitaire	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	presence of MACE (major adverse cardiovascular event) following the oximetry test	12 months
Secondary	Morbidity	presence of MALE (major adverse lower limb event) following the oximetry test	12 moths
Secondary	Mortality (intermediate analysis)	Mortality all causes (intermediate analysis prior to Covid interference)	6 months minimal follow-up