[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07696988":3,"trial-entities:NCT07696988":120,"trial-summary:NCT07696988":126},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":59,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":15,"eligibility_criteria":63,"std_ages":83,"locations":86,"central_contacts":111,"overall_officials":116,"references":118,"see_also_links":119},"NCT07696988","RRD5-006-25W","PNS to Improve Vascular Function and Limb Health in Veterans","Peripheral Neural Stimulation to Improve Microvascular Function and Limb Health in Veterans With Diabetic Peripheral Neuropathy","NOT_YET_RECRUITING","2030-05-30","2026-07","2026-07-10","2026-11-02","VA Office of Research and Development","FED",true,"Establishing a sensitive, scalable physiological test for neurovascular reflex integrity and investigating whether targeted peripheral neural stimulation can enhance perfusion and vasodilatory responsiveness.","The overarching goal of this project is to define how targeted afferent activation can be used to restore impaired neurovascular reflexes, improve skin perfusion, and ultimately prevent further decline in limb health in Veterans. By integrating functional and structural imaging with neural modulation, this work will establish foundational evidence for diagnostic and therapeutic strategies aimed at early detection of neurovascular decline and prevention of tissue breakdown in both Diabetic Peripheral Neuropathy (DPN) and residual-limb contexts. Furthermore, this work will establish the feasibility of preventing or delaying the mechanical trauma of the insensate distal limb which invariably leads to deep pressure injuries, infections, and amputation in Veterans with DPN. The findings have the potential to transform care by enabling earlier diagnosis, improving neurovascular responsiveness, and optimizing neuromodulation protocols to prevent skin complications, delay progression toward amputation, and improve quality of life in Veterans with DPN or limb loss.",[19,20],"Lower Limb Amputees","Diabetes",[22,20],"lower extremity limb loss","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[26],"NA",{"count":28,"type":29},42,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","Chronically Implanted Neural and Muscular Interface","The implanted neural and and muscular interface will be used to characterize neurovascular reflex testing (thermal axon reflex \\& pressure-induced vasodilation) and microvascular imaging using Laser Doppler Flowmetry and PAI. Reflex responses will be evaluated under baseline and stimulation conditions (sham, tonic, biomimetic), with direct stimulation performed by the CFINE cohort for modality comparison. Structural-functional relationships will be modeled by integrating metrics from PAI with reflex outcomes.",[36],"Implanted Neural and Muscular Interface",{"type":32,"name":38,"description":39,"armGroupLabels":40},"Peripheral Nerve Stimulation (PNS)","The cutaneous peripheral nerve stimulation interface will be used to characterize neurovascular reflex testing (thermal axon reflex \\& pressure-induced vasodilation) and microvascular imaging using Laser Doppler Flowmetry and PAI. Reflex responses will be evaluated under baseline and stimulation conditions (sham, tonic, biomimetic). Structural-functional relationships will be modeled by integrating metrics from PAI with reflex outcomes.",[36,41],"Peripheral nerve stimulation",[43,47,50,53,56],{"measure":44,"description":45,"timeFrame":46},"Cutaneous Vascular Conductance","Autonomic reflex testing including thermal axon reflex and pressure induced vasoconstriction will be applied. The cutaneous blood flow in the lower limb will be measured using laser doppler flowmetry. The flux is divided by mean arterial pressure to calculate cutaneous vascular conductance. This provides a physiologically relevant metric of microvascular control by accounting for systemic pressure fluctuations","baseline and visits 1-15 until study completion, average 1 year",{"measure":48,"description":49,"timeFrame":46},"Vessel Density","Defined as the percentage of tissue volume occupied by vascular structures. The investigators use photoacoustic imaging of microvascular structure to quantify microvascular structural integrity at distal and proximal skin sites. From the reconstructed volumetric data, the investigators will extract the vessel density",{"measure":51,"description":52,"timeFrame":46},"Tissue Oxygen Saturation","Tissue oxygen saturation or sO2 will be measured during different conditions of the study such as thermal axon reflex and pressure induced vasoconstriction using reflectance spectroscopy",{"measure":54,"description":55,"timeFrame":46},"Mean Vessel Diameter","Calculated from the cross-sectional profiles of resolved vessels obtained from the photoacoustic imaging of microvascular structures",{"measure":57,"description":58,"timeFrame":46},"Hemoglobin Oxygenation","From photoacoustic imaging, hemoglobin oxygenation is derived and compared across different study conditions",[],"ALL","18 Years",null,{"inclusion":64,"exclusion":71,"raw_text":82},[65,66,67,68,69,70],"English-speaking","Confirmed diagnosis of type 1 or type 2 diabetes mellitus for at least 5 years","Clinical signs and\u002For symptoms consistent with diabetic peripheral neuropathy Or confirmation of neuropathy via physical exam","Unilateral transtibial or transfemoral amputation","Medically stable for at least 3 months","For the designated subset of the limb-loss cohort (n = 6): implanted with C-FINEs on the sciatic and\u002For tibial nerves",[72,73,74,75,76,77,78,79,80,81],"Severe neurological disorders impairing ambulation","Visual or hearing impairments interfering with study participation","Cardiovascular or respiratory conditions posing risk during participation","Cognitive or psychiatric conditions compromising informed consent","Participation in other clinical trials interfering with outcomes","Pregnancy","History of photosensitivity or known sensitivity to laser light","Active skin breakdown or infection at residual limb","Significant phantom or residual limb pain interfering with study procedures","Bilateral lower-limb amputation","Inclusion Criteria:\n\nInclusion Criteria - All Participants:\n\n* English-speaking\n\nInclusion Criteria - DPN Participants:\n\n* Confirmed diagnosis of type 1 or type 2 diabetes mellitus for at least 5 years\n* Clinical signs and\u002For symptoms consistent with diabetic peripheral neuropathy Or confirmation of neuropathy via physical exam\n\nInclusion Criteria - Lower Limb Amputees:\n\n* Unilateral transtibial or transfemoral amputation\n* Medically stable for at least 3 months\n* For the designated subset of the limb-loss cohort (n = 6): implanted with C-FINEs on the sciatic and\u002For tibial nerves\n\nExclusion Criteria:\n\nExclusion Criteria - All Participants:\n\n* Severe neurological disorders impairing ambulation\n* Visual or hearing impairments interfering with study participation\n* Cardiovascular or respiratory conditions posing risk during participation\n* Cognitive or psychiatric conditions compromising informed consent\n* Participation in other clinical trials interfering with outcomes\n* Pregnancy\n* History of photosensitivity or known sensitivity to laser light\n\nAdditional Exclusion Criteria - Amputees:\n\n* Active skin breakdown or infection at residual limb\n* Significant phantom or residual limb pain interfering with study procedures\n* Bilateral lower-limb amputation",[84,85],"ADULT","OLDER_ADULT",[87],{"facility":88,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":108},"Louis Stokes VA Medical Center, Cleveland, OH","Cleveland","Ohio","44106-1702","United States",[94,100,105],{"name":95,"role":96,"phone":97,"phoneExt":98,"email":99},"Jessica R Jarvela, MS BS","CONTACT","216-791-3800","63801","Jessica.Jarvela@va.gov",{"name":101,"role":96,"phone":102,"phoneExt":103,"email":104},"Aarika Sheehan, DPT","(216) 791-3800","65832","Aarika.Sheehan@va.gov",{"name":106,"role":107},"Hamid Charkhkar, PhD","PRINCIPAL_INVESTIGATOR",{"lat":109,"lon":110},41.4995,-81.69541,[112,115],{"name":106,"role":96,"phone":102,"phoneExt":113,"email":114},"62924","Hamid.Charkhkar@va.gov",{"name":95,"role":96,"phone":102,"phoneExt":98,"email":99},[117],{"name":106,"affiliation":88,"role":107},[],[],{"nct_id":4,"conditions":121,"biomarkers":125},[122,123,124],"Amputation of lower limb","Diabetes Mellitus","Diabetic peripheral neuropathy",[],{"nct_id":4,"found":15,"summary":127,"prompt_version":137},{"design":128,"status":129,"heading":130,"summary":131,"follow_up":132,"word_count":133,"commitments":134,"compensation":135,"drugs_mentioned":136},"This is an interventional study planning to enroll 42 participants. It will test two types of devices: a Chronically Implanted Neural and Muscular Interface and a Peripheral Nerve Stimulation (PNS) interface.","completed","PNS for Vascular Function and Limb Health in Veterans","This study is looking at how a treatment called Peripheral Nerve Stimulation (PNS) can help improve blood flow and overall limb health in Veterans. It's also testing a new way to measure nerve and blood vessel health using an implanted device. You might be able to join if you are a Veteran with diabetes and nerve damage (diabetic peripheral neuropathy) or if you've had a lower limb amputation. The researchers want to see if PNS can improve how well your blood vessels respond and increase blood flow to your skin. This could help prevent skin problems and further limb issues. The study aims to enroll 42 participants, but its current status is unclear.","Participants will be followed for approximately one year, with measurements taken until study completion.",113,"You would have visits for about one year, with measurements taken at baseline and then at visits 1-15. These measurements include checking your skin's blood flow, vessel density, and tissue oxygen levels.","Not stated in the trial record.",[38],"v2"]