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Correlation Between FlowMet™ and Other Gold Standard Assessments in the Management of Critical Limb Ischemia (CLI)

NCT03094559 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-04-13

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the utility of the FlowMet™ device in the assessment of perfusion in subjects suspected of or being treated for critical limb ischemia, in comparison to other gold standard technologies, such as ankle brachial pulse index (ABI), skin perfusion pressure (SPP), toe brachial pulse index (TBI), transcutaneous oxygen tension (TcP02), and angiography currently in use in the clinic.

Conditions

  • Critical Limb Ischemia

Interventions

DEVICE

FlowMet

The FlowMet device will be placed on the index finger of the right hand. Signal fidelity will be assured by confirming the presence of a pulse waveform if one is expected and by assuring that an appropriate amount of light is be detected by the FlowMet device. Following placement of the FlowMet device, a period of 10 seconds will be allowed to elapse to allow transient changes in perfusion due to device placement to diminish. FlowMet blood flow data will be recorded for 20 seconds using the FlowMet data acquisition software. These steps will be repeated for digits 1 and 2 on the limb with diagnosed or suspected CLI, or on both limbs if both are diagnosed or suspected of having CLI.

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Mehdi Shishehbor · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-07
Primary Completion
2018-01-31
Completion
2018-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03094559 on ClinicalTrials.gov