NOVICE: New Oxymetry Indices in Critical Limb Ischemia

• Sponsor: University Hospital, Angers (Other)
• Overall Status: Completed
• CT.gov ID: NCT04209998
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Actual Duration (Months): 22.5
• Patients Per Site Per Month: 13.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Limb Ischemia	Diagnostic Test: transcutaneous oximetry

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Other
• 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")
• Actual Study Start Date: Jan 16, 2020
• Actual Primary Completion Date: Dec 1, 2021
• Actual Study Completion Date: Dec 1, 2021

Outcome Measures

Primary Outcome Measures

1. Mortality [12 months]

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

Secondary Outcome Measures

1. Morbidity [12 moths]

   presence of MALE (major adverse lower limb event) following the oximetry test

2. Mortality (intermediate analysis) [6 months minimal follow-up]

   Mortality all causes (intermediate analysis prior to Covid interference)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre hospitalier universitaire	Angers		France	49933

Sponsors and Collaborators

• University Hospital, Angers

Investigators

• Principal Investigator: ABRAHAM Pierre, MD PhD, University Hospital in Angers

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Angers
• ClinicalTrials.gov Identifier: NCT04209998
• Other Study ID Numbers: 2019-A02619-48
• First Posted: Dec 24, 2019
• Last Update Posted: Jun 24, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Angers: transcutaneous oximetry; oxygen; peripheral artery disease; follow-up
• Additional relevant MeSH terms: Ischemia

Study Results

No Results Posted as of Jun 24, 2022