Clinical trial NCT05455554: The Use of FlowMet-R Technology to Predict Wound Healing in CLI Patients in a Wound Care Center Setting
Official title: The Use of FlowMet-R Technology to Predict Wound Healing in Critical Limb Ischemia (CLI) Patients in a Wound Care Center Setting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Limb Ischemia
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Medtronic Endovascular
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-07-13
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Wound Healing
timeFrame: 6 months
measure: Wound Improvement
timeFrame: 6 months
measure: Major Amputation
timeFrame: 6 months
measure: Minor Amputation
timeFrame: 6 months
measure: Repeat Revascularization
timeFrame: 6 months
Secondary outcomes:
measure: Response to Hyperbaric Oxygen Therapy
timeFrame: 6 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Hospital
state: California
Study officials:
affiliation: Stanford University
name: Venita Chandra, MD
role: PRINCIPAL_INVESTIGATOR
References: