Diabetes mellitus (DM) is a common condition (34M in USA). Approximately 1 in 7 DM patients have diabetic foot ulcers (DFU). Approximately half of patients with DFU have concomitant peripheral arterial disease (PAD), resulting in US prevalence of 2.5M patients with ischemic or neuroischemic DFUs. Patients with DFUs experience recurrent hospitalizations, chronic wound healing issues, and ultimately amputations that severely limit quality of life and productivity and place a significant burden of care on families and a sizable cost for the healthcare system. The patients with DFUs experience either some bone removal (750K to 1.35M ) or amputation (170K) annually, making new options necessary to treat these patients and prevent the costly amputations and hospitalizations. Patients with DFUs who also have PAD experience these symptoms because of poor blood flow both in the larger arteries delivering blood to the lower leg and in the smaller vessels branching out to supply the muscles and tissues of the lower leg and foot. Acoustic energy modalities such as therapeutic ultrasound (TUS) have been shown to promote collateral vessel growth, angiogenesis, and to improve perfusion in animal models of coronary artery disease and PAD, with promising early human data in both disease processes. Vibrato Medical has developed a novel treatment with the first wearable therapeutic ultrasound (TUS) device for the non-invasive, outpatient treatment of PAD that will promote collateral vessel growth and angiogenesis, restore perfusion and reduce amputation rates. We have already demonstrated VibratoSleeves efficacy in markedly improving lower extremity perfusion in healthy volunteers using multiple perfusion measures. The goal of this Phase I SBIR proposal is to conduct a prospective open-label clinical trial designed to evaluate the acute improvement in perfusion to ischemic or neuro-ischemic DFUs. A total of 12 subjects will receive wearable VibratoSleeve treatment to the posterior calf for 90 minutes at 3 separate clinic visits at low, medium and high acoustic intensity settings. Efficacy will be assessed by comparing baseline and on- therapy, and mean improvements in each endpoint will be compared across all 3 intensities to determine a dose-response relationship. We will also systematically obtain patient feedback on ease of use, tolerability, and comfort of VibratoSleeve using a standardized questionnaire administered after each 90-minute treatment. Data on the tactile sensation and comfort will inform optimal acoustic parameters, treatment duration and design of a subsequent sham-controlled clinical trial of long-term TUS therapy to assess DFU healing. Public Health Relevance Statement PROJECT NARRATIVE Half of patients with diabetic foot ulcers (DFU) have concomitant peripheral arterial disease (PAD), termed ischemic or neuroischemic DFUs (US prevalence 2.5M) and limited therapeutic options. Acoustic therapies such as therapeutic ultrasound (TUS) have been shown to be effective in promoting collateral vessel growth and angiogenesis and improving perfusion for PAD and coronary artery disease, and have early data in improving wound healing. Vibrato Medical has developed a disruptive, paradigm-shifting treatment for DFUs with the first wearable ultrasound device for non-invasive, at-home use, and now aims to conduct a feasibility study providing TUS therapy to neuroischemic and ischemic DFUs.
Project Terms: Acoustics ; Acoustic ; Adoption ; Ambulatory Care ; Outpatient Care ; outpatient treatment ; Amputation ; Arteries ; Beds ; Blood ; Blood Reticuloendothelial System ; bone ; Clinic Visits ; Clinical Research ; Clinical Study ; Controlled Clinical Trials ; Coronary Arteriosclerosis ; Coronary Artery Disease ; Coronary Artery Disorder ; Coronary Atherosclerosis ; atherosclerotic coronary disease ; coronary arterial disease ; Debridement ; Diabetes Mellitus ; diabetes ; Diagnosis ; Disease ; Disorder ; Family ; Feasibility Studies ; Feedback ; foot ; Gangrene ; Goals ; Growth ; Generalized Growth ; Tissue Growth ; ontogeny ; Hand ; Healthcare Systems ; Health Care Systems ; Health Personnel ; Health Care Providers ; Healthcare Providers ; Healthcare worker ; health care personnel ; health care worker ; health provider ; health workforce ; healthcare personnel ; medical personnel ; treatment provider ; Hemoglobin ; Hospitalization ; Hospital Admission ; Human ; Modern Man ; Infection ; Ischemia ; Laser Electromagnetic ; Laser Radiation ; Lasers ; Lower Limb ; Membrum inferius ; Lower Extremity ; Muscle Tissue ; muscular ; Muscle ; O element ; O2 element ; Oxygen ; Patients ; Perfusion ; Play ; pressure ; Productivity ; Prospective Studies ; QOL ; Quality of life ; Questionnaires ; Recurrent ; Recurrence ; Risk ; social role ; Role ; Safety ; Sonication ; Standardization ; Body Tissues ; Tissues ; Echography ; Echotomography ; Medical Ultrasound ; Ultrasonic Imaging ; Ultrasonogram ; Ultrasound Diagnosis ; Ultrasound Medical Imaging ; Ultrasound Test ; diagnostic ultrasound ; sonogram ; sonography ; sound measurement ; ultrasound ; ultrasound imaging ; ultrasound scanning ; Ultrasonography ; ultrasound energy ; ultrasound therapy ; Ultrasonic Therapy ; Vasodilatation ; Vasorelaxation ; Vasodilation ; Wound Repair ; wound resolution ; wound healing ; Measures ; Health Costs ; Healthcare Costs ; Health Care Costs ; Mediating ; Advanced Glycation End Products ; advanced glycation endproduct ; advanced glycosylation endproduct ; Advanced Glycosylation End Products ; improved ; Acute ; Clinical ; Phase ; Medical ; Training ; Blood flow ; diabetic ; Measurement ; autonomic neuropathy ; Therapeutic ; angiogenesis ; Treatment Period ; treatment days ; treatment duration ; restoration ; Operative Procedures ; Surgical ; Surgical Interventions ; Surgical Procedure ; surgery ; Operative Surgical Procedures ; experience ; human data ; Animal Models and Related Studies ; model of animal ; model organism ; Animal Model ; Response Elements ; Structure ; novel ; Modality ; Devices ; Manpower ; personnel ; Human Resources ; Touch ; tactile sensation ; Touch sensation ; Abscission ; Extirpation ; Removal ; Surgical Removal ; resection ; Excision ; response ; tissue oxygen saturation ; tissue oxygenation ; portability ; Adverse Experience ; Adverse event ; Leg ; preventing ; prevent ; Causality ; causation ; disease causation ; Etiology ; Address ; Dose ; diabetic foot wound ; Diabetic Foot Ulcer ; Symptoms ; Data ; Improve Access ; Clinical Trials Design ; Perioperative ; Severe Adverse Event ; serious adverse experience ; serious adverse reaction ; Serious Adverse Event ; SBIR ; Small Business Innovation Research ; Small Business Innovation Research Grant ; Process ; peripheral artery disease ; Peripheral arterial disease ; imaging ; Image ; open label study ; open label ; care burden ; cost ; healing ; clinical efficacy ; Outcome ; human study ; Impaired wound healing ; Impaired tissue repair ; abnormal tissue repair ; delayed wound healing ; Population ; Prevalence ; prospective ; clinical effect ; healthy volunteer ; therapy design ; intervention design ; treatment design ; high risk ; trial design ; chronic wound ; chronic skin wound ; Spatial Frequency Domain Imaging ; first-in-human ; first in man ; Home ;
