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

Critical Limb Ischemia Clinical Trial

Official title:

The Use of FlowMet-R Technology to Predict Wound Healing in Critical Limb Ischemia (CLI) Patients in a Wound Care Center Setting

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05455554
• Other study ID #: 62133
• Secondary ID: 5R38HL143615-02
• Status: Enrolling by invitation
• Start date: April 27, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: July 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia

Intervention

Diagnostic Test:
• Flowmet-D
Flowmet-D is a non-invasive device that measures blood flow.
• 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.

Locations

Country	Name	City	State
United States	Stanford Hospital	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	Medtronic Endovascular, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Healing	Wound Healing, defined as complete skin epithelialization, will be associated with Flowmet-D measurements.	6 months
Primary	Wound Improvement	Wound Improvement, defined as improvement in wound size, will be associated with Flowmet-D values.	6 months
Primary	Major Amputation	Major amputation, defined as amputation above the ankle joint, will be associated with Flowmet-D values.	6 months
Primary	Minor Amputation	Minor amputation, defined as amputation below the ankle joint, will be associated with Flowmet-D values.	6 months
Primary	Repeat Revascularization	Repeat Revascularization, defined as unplanned repeat lower extremity revascularization, will be monitored.	6 months
Secondary	Response to Hyperbaric Oxygen Therapy	Response to Hyperbaric Oxygen Therapy, will be defined as improved perfusion (improved Flowmet-D value) following therapy	6 months