An observational study in Critical Limb Ischemia, sponsored by Stanford University. Status unknown at 1 site in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2022-07-13.
Sponsored by Stanford University · Observational
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.
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.
343 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 70 are open to participants now.
This study's planned enrollment of 100 is below the median of 123 across 98 observational studies indexed under Chronic Limb-Threatening Ischemia.
Browse Chronic Limb-Threatening Ischemia studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
CLI Cohort:
HBO Cohort:
Exclusion Criteria:
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 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
Flowmet-D is a non-invasive device that measures blood flow.
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.
Wound Healing
Wound Healing, defined as complete skin epithelialization, will be associated with Flowmet-D measurements.
Time frame: 6 months
Wound Improvement
Wound Improvement, defined as improvement in wound size, will be associated with Flowmet-D values.
Time frame: 6 months
Major Amputation
Major amputation, defined as amputation above the ankle joint, will be associated with Flowmet-D values.
Time frame: 6 months
Minor Amputation
Minor amputation, defined as amputation below the ankle joint, will be associated with Flowmet-D values.
Time frame: 6 months
Repeat Revascularization
Repeat Revascularization, defined as unplanned repeat lower extremity revascularization, will be monitored.
Time frame: 6 months
Response to Hyperbaric Oxygen Therapy
Response to Hyperbaric Oxygen Therapy, will be defined as improved perfusion (improved Flowmet-D value) following therapy
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Chronic Limb-Threatening Ischemia→
Stanford University