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

• Conditions: Critical Limb Ischemia
• Interventions: Diagnostic Test: Flowmet-D; Diagnostic Test: ABI

• Registration Number: NCT05455554
• Lead Sponsor: Stanford University

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.

Detailed Description

A single-institution, prospective nonrandomized pilot study will be conducted at Stanford Hospital and the Stanford Advanced Wound Care Center (AWCC). Patients with CLTI by WIfI criteria (ABI or toe pressures) and a concomitant non-healing lower extremity wound will be recruited. Inclusion criteria will include CLTI, at least one active lower extremity wound and planned lower extremity revascularization. ABI/TBIs will be recorded preintervention, post intervention and at one and three month intervals. Intraprocedural characteristics including the number and location of vessels revascularized, patent runoff vessels pre and post procedure, pedal arch anatomy and presence of angiographic "blush" to wound will be documented.

Post-operatively, patients will be followed at the AWCC where they will receive standard of care wound management including offloading, regular debridement, infection and edema management. FlowMet-R perfusion values will be obtained prerevascularization, immediately post revascularization as well as weekly at each follow up AWCC visit for a total of up to 6 months or until wound healing.Wound size will be recorded.

Patients who undergo hyperbaric oxygen therapy (at the discretion of AWCC surgeon) will have perfusion values performed before and after hyperbaric oxygen therapy sessions 1, 2, 10, 20, 30 and 40. Hyperbaric oxygen therapy will be conducted 5 days a week for duration of 90 minutes. Patients who undergo other advanced wound care treatments such as stem cell therapies or skin substitutes will also received FlowMet-R prior to and after treatment. Primary outcomes will be wound healing defined as complete skin epithelialization, wound improvement rate, major and minor amputations as well as need for repeat revascularization.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-12-14
• Study Start: 2022-04-27
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-07
• Last Update Submitted: 2022-07-07
• Study First Posted: 2022-07-13
• Last Update Posted: 2022-07-13
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CLI (Critical Limb Ischemia)	Flowmet-D	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.
HBO (Hyperbaric Oxygen)	ABI	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.
CLI (Critical Limb Ischemia)	ABI	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.
HBO (Hyperbaric Oxygen)	Flowmet-D	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.

Primary Outcome Measures

Name	Time	Method
Wound Healing	6 months	Wound Healing, defined as complete skin epithelialization, will be associated with Flowmet-D measurements.
Wound Improvement	6 months	Wound Improvement, defined as improvement in wound size, will be associated with Flowmet-D values.
Minor Amputation	6 months	Minor amputation, defined as amputation below the ankle joint, will be associated with Flowmet-D values.
Repeat Revascularization	6 months	Repeat Revascularization, defined as unplanned repeat lower extremity revascularization, will be monitored.
Major Amputation	6 months	Major amputation, defined as amputation above the ankle joint, will be associated with Flowmet-D values.

Secondary Outcome Measures

Name	Time	Method
Response to Hyperbaric Oxygen Therapy	6 months	Response to Hyperbaric Oxygen Therapy, will be defined as improved perfusion (improved Flowmet-D value) following therapy

Trial Locations

Locations (1)

Stanford Hospital; 🇺🇸 Stanford, California, United States