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The Use of FlowMet-R Technology to Predict Wound Healing in CLI Patients in a Wound Care Center Setting

NCT05455554 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-07-13

No results posted yet for this study

Summary

Single-institution, prospective nonrandomized pilot study of critical limb ischemia patients with planned lower extremity revascularization will undergo Flowmet-D measurements in a wound care center setting to determine threshold values associated with wound healing and amputation. A subset of patients will undergo hyperbaric oxygen therapy and will have Flowmet-D measurements to determine those who respond best to therapy.

Conditions

  • Critical Limb Ischemia

Interventions

DIAGNOSTIC_TEST

Flowmet-D

Flowmet-D is a non-invasive device that measures blood flow.

DIAGNOSTIC_TEST

ABI

ABI is the ratio of the systolic blood pressure measured at the ankle to that measured at the brachial artery and is considered the gold standard for the diagnosis of peripheral artery disease.

Sponsors & Collaborators

  • Medtronic Endovascular

    collaborator INDUSTRY

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Stanford University

    lead OTHER

Principal Investigators

  • Venita Chandra, MD · Stanford University

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-27
Primary Completion
2023-09-01
Completion
2023-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT05455554 on ClinicalTrials.gov