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

NCT05455554 | Unknown FDA Device

• 2 other identifiers: 621335R38HL143615-02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• Wound Healing

  Wound Healing, defined as complete skin epithelialization, will be associated with Flowmet-D measurements.

  6 months

• Wound Improvement

  Wound Improvement, defined as improvement in wound size, will be associated with Flowmet-D values.

  6 months

• Major Amputation

  Major amputation, defined as amputation above the ankle joint, will be associated with Flowmet-D values.

  6 months

• Minor Amputation

  Minor amputation, defined as amputation below the ankle joint, will be associated with Flowmet-D values.

  6 months

• Repeat Revascularization

  Repeat Revascularization, defined as unplanned repeat lower extremity revascularization, will be monitored.

  6 months

Secondary Outcomes (1)

• Response to Hyperbaric Oxygen Therapy

  6 months

Study Arms (2)

CLI (Critical Limb Ischemia)

CLI cohort is a population of individuals with CLI, at least one active lower extremity wound and planned lower extremity revascularization. CLI cohort patients will receive Flowmet-D measurements in addition to standard of care therapy following intervention.

Diagnostic Test: Flowmet-D; Diagnostic Test: ABI

HBO (Hyperbaric Oxygen)

HBO cohort is a subset of the CLI cohort who will undergo hyperbaric oxygen therapy in the post-operative setting who will receive Flowmet-D measurements before and after their therapy.

Diagnostic Test: Flowmet-D; Diagnostic Test: ABI

Interventions

Flowmet-D DIAGNOSTIC_TEST

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

CLI (Critical Limb Ischemia); HBO (Hyperbaric Oxygen)

ABI DIAGNOSTIC_TEST

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.

CLI (Critical Limb Ischemia); HBO (Hyperbaric Oxygen)

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The CLI population is individuals with CLTI, at least one active lower extremity wound and planned lower extremity revascularization. The HBO cohort is a subset of the CLI population who will undergo HBO therapy post-revascularization.

You may qualify if:

• CLI Cohort:
• CLI by WIfI criteria (ABI or toe pressures)
• Non-healing lower extremity wound
• Planned lower extremity revascularization
• Able to provide informed consent
• Able to comply with study procedures
• HBO Cohort:
• All of the above
• Enrolled in HBO therapy post revascularization (at the discretion of the provider)

You may not qualify if:

• Under 30
• Wound not suitable for FlowMet-D probe attachment

Sponsors & Collaborators

• Stanford University: lead
• Medtronic Endovascular: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Stanford Hospital

Stanford, California, 94061, United States

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; 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

• Venita Chandra, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: July 13, 2022
• Study Start: April 27, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)