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

NCT03094559 | Withdrawn DMC

• 1 other identifier: 16-1223
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

peripheral arterial disease

Outcome Measures

Primary Outcomes (4)

• Correlation between FlowMet perfusion values and ankle-brachial index and toe-brachial index in 34 patients who present to outpatient clinic.

  Correlation between FlowMet perfusion values evaluating the median systolic, median diastolic, and overall flow and amplitude as compared to ABI and TBI. This is a feasibility study to determine the degree of correlation between this novel device and current standard of care testing to see how the numerical values obtained correlate with both normal and abnormal values of well established testing. Normal values of ABI (ratios of \> 0.9 to \< 1.3) and TBI (ratios of \> 0.7).

  One year

• Correlation between FlowMet perfusion values and skin perfusion pressure in 34 patients who present to outpatient clinic.

  Correlation between FlowMet perfusion values evaluating the median systolic, median diastolic, and overall flow and amplitude as compared to skin perfusion pressure testing. This is a feasibility study to determine the degree of correlation between this novel device and current standard of care testing to see how the numerical values obtained correlate with both normal and abnormal values of well established testing. Normal values of SPP are 40-50 mmHg.

  One year

• Correlation between FlowMet perfusion values and transcutaneous oxygen tension in 34 patients who present to outpatient clinic.

  Correlation between FlowMet perfusion values evaluating the median systolic, median diastolic, and overall flow and amplitude as compared to transcutaneous oxygen testing. This is a feasibility study to determine the degree of correlation between this novel device and current standard of care testing to see how the numerical values obtained correlate with both normal and abnormal values of well established testing. Normal value at the foot is 40-50 mmHg.

  One year

• Correlation between FlowMet perfusion values and angiography in 34 patients who present to outpatient clinic.

  Correlation between FlowMet perfusion values evaluating the median systolic, median diastolic, and overall flow and amplitude as compared to angiography. This is a feasibility study to determine the degree of correlation between this novel device and current standard of care testing to see how the numerical values obtained correlate with both normal and abnormal angiographic images as defined by severity of stenosis.

  One year

Secondary Outcomes (3)

• Correlation between FlowMet perfusion values and Rutherford score

  One year

• Correlation between FlowMet perfusion values and time of surgical (re)admission

  One year

• Correlation between FlowMet perfusion values and speed of wound healing

  One year

Study Arms (1)

FlowMet device

EXPERIMENTAL

This is a feasibility study

Device: FlowMet

Interventions

FlowMet DEVICE

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.

FlowMet device

Eligibility Criteria

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

You may qualify if:

• Subject is willing and able to provide an informed consent.
• Subject is willing and able to comply with the study procedures.
• Subject is able to understand the study procedures.
• Subject is being seen at the clinic for the evaluation/treatment of CLI.
• Subject has a Rutherford score of V or VI.

You may not qualify if:

• Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
• Anyone with a latex allergy
• Must be over 18 years old
• Must not be pregnant during time of study

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (16)

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  BACKGROUND

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MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease

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

Study Officials

• Mehdi Shishehbor

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 29, 2017
• Study Start: March 7, 2017
• Primary Completion: January 1, 2018
• Study Completion: June 1, 2018
• Last Updated: April 13, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)