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

NCT ID: NCT05455554

Last Updated: 2022-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-27
• Study Completion Date: 2023-09-01

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.

Conditions

Critical Limb Ischemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Flowmet-D

Intervention Type: DIAGNOSTIC_TEST

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

ABI

Intervention Type: 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.

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.

Flowmet-D

Intervention Type: DIAGNOSTIC_TEST

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

ABI

Intervention Type: 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.

Interventions

Flowmet-D

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

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

Exclusion Criteria

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Endovascular

INDUSTRY

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Venita Chandra

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Venita Chandra, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Hospital

Stanford, California, United States

Countries

United States

Other Identifiers

5R38HL143615-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

62133

Identifier Type: -

Identifier Source: org_study_id