[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654065":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":51,"studyPopulation":51,"armGroups":59,"interventions":112,"overallOfficials":127,"centralContacts":131,"locations":137,"responsibleParty":473,"collaborators":476,"id":479,"slug":480,"hasResults":481,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":485,"eligibilityCriteria":486,"healthyVolunteers":481,"sex":487,"minAge":488,"maxAge":51,"enrollmentInfo":489,"targetDuration":51,"studyType":492,"phases":493,"briefSummary":495,"conditions":496,"keywords":51,"overallStatus":499,"whyStopped":51,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":509},{"fullName":5,"class":6},"University of Michigan","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":51},[9],{"measure":10,"description":11,"timeFrame":12},"Patient-centered utility function as a measure for efficacy and tolerability","Efficacy and tolerability will be assessed and measured as utility function. Utility function ranges from 0-1.75, 0 being the lowest utility function and 1.75 being the highest utility function. Utility function that is a composite of efficacy (0-1) and discontinuation (0-1).","Up to 8 months.",[14,17,20,24,27,30,33,36,39,42,45,48],{"measure":15,"description":16,"timeFrame":12},"Pain intensity","Pain intensity as measured by first question of the \"Pain, Enjoyment, General Activity\" (PEG) numeric rating scale, where a score of 0 is no pain and 10 is the worst pain imaginable.",{"measure":18,"description":19,"timeFrame":12},"Pain interference","Pain interference as measured by the sum of the second two questions of the \"Pain, Enjoyment, General Activity\" (PEG) numeric rating scale, where a score of 0 is no interference with daily life and 20 is the complete interference with daily life.",{"measure":21,"description":22,"timeFrame":23},"Discontinuation","Rate of treatment discontinuation for any reason, including withdrawal From enrollment to end of treatment at 8 months.","Up to 8 months",{"measure":25,"description":26,"timeFrame":12},"Related adverse events","Adverse events reported by local sites and determined to be related to the treatment.",{"measure":28,"description":29,"timeFrame":12},"Physical functioning\u002FQuality of Life (QOL)","Physical function\u002FQOL as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical functioning Short Form 6b, a 5 question questionnaire. Each question is measured with a likert scale, where 5 is \"without any difficulty\" and 1 is \"unable to do\"",{"measure":31,"description":32,"timeFrame":23},"Neuropathy specific QOL","Neuropathy Quality of Life (NeuroQOL) evaluates symptoms and function in regard to quality of life over the past four weeks. Range 1-15, higher score indicates neuropathy having a greater impact on quality of life.",{"measure":34,"description":35,"timeFrame":23},"Depression","As measured by the Patient Health Questionnaire (PHQ-2), a two-question questionnaire where each depression symptom is scored on a scale of 0-3, where 0 is \"not at all\" and 3 is \"nearly every day\". The total score range is 0-6 where the higher score indicates more depression symptoms.",{"measure":37,"description":38,"timeFrame":23},"Anxiety","As measured by the General Anxiety Disorder (GAD-2), a two-question questionnaire where each anxiety symptom is scored on a scale of 0-3, where 0 is \"not at all\" and 3 is \"nearly every day\". The total score range is 0-6 where the higher score indicates more anxiety symptoms.",{"measure":40,"description":41,"timeFrame":23},"Sleep","Sleep Quality represented by the sum of scores on the PROMIS Sleep Disturbance 6a and an additional question regarding sleep duration.",{"measure":43,"description":44,"timeFrame":23},"Pain Catastrophizing","As measured by the Pain Catastrophizing Scale Short Form 6, where a score of 0 is catastrophizing \"not at all\" and 52 is catastrophizing \"all the time\"",{"measure":46,"description":47,"timeFrame":23},"Global treatment satisfaction","As measured by Patient Global Impression of Change (PGIC), a single question on a scale of 0-6, where 0 is \"very much improved\" and 6 is \"very much worse\".",{"measure":49,"description":50,"timeFrame":23},"Substance use screener","As measured by the Tobacco, Alcohol, Prescription Medications, and other Substance (TAPS 1) questionnaire, which is five questions on a scale of 0-4, where 0 is \"daily or almost daily use\" and 4 is \"never use\".",null,{"allocation":53,"interventionModel":54,"interventionModelDescription":55,"primaryPurpose":56,"observationalModel":51,"timePerspective":51,"maskingInfo":57},"RANDOMIZED","CROSSOVER","a comparative-effectiveness sequential, multiple assignment, randomized trial","TREATMENT",{"masking":58,"maskingDescription":51,"whoMasked":51},"NONE",[60,66,70,75,80,84,88,92,96,100,104,108],{"label":61,"type":62,"description":63,"interventionNames":64},"Oral Medication then New Oral Medication","EXPERIMENTAL","Participants randomized to oral medications, and are considered non-responders at 4 months will be rerandomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to oral medications will select a new oral medication for the next 4 months.",[65],"Drug: Oral Medication",{"label":67,"type":62,"description":68,"interventionNames":69},"Oral Medication then Same Oral Medication","Participants randomized to oral medications, and are considered responders at 4 months will continue with the same oral medication for the next 4 months.",[65],{"label":71,"type":62,"description":72,"interventionNames":73},"Oral Medication then Topical Medication","Participants randomized to oral medications, and are considered non-responders at 4 months will be rerandomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to topical medications will select a topical medication for the next 4 months.",[65,74],"Drug: Topical Medication",{"label":76,"type":62,"description":77,"interventionNames":78},"Oral Medication then Cognitive Behavioral Therapy","Participants randomized to oral medications, and are considered non-responders at 4 months will be re-randomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to a behavioral intervention will begin self-guided CBT for the next 4 months.",[79,65],"Device: Cognitive Behavioral Therapy (CBT)",{"label":81,"type":62,"description":82,"interventionNames":83},"Topical Medication then New Topical Medication","Participants randomized to topical medications, and are considered non-responders at 4 months will be rerandomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to topical medications will select a new topical medication for the next 4 months.",[74],{"label":85,"type":62,"description":86,"interventionNames":87},"Topical Medication then Same Topical Medication","Participants randomized to topical medications, and are considered responders at 4 months will continue with the same topical medication for the next 4 months.",[74],{"label":89,"type":62,"description":90,"interventionNames":91},"Topical Medication then Oral Medication","Participants randomized to topical medications, and are considered non-responders at 4 months will be re-randomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to oral medications will select an oral medication for the next 4 months.",[65,74],{"label":93,"type":62,"description":94,"interventionNames":95},"Topical Medication then Cognitive Behavioral Therapy","Participants randomized to topical medications, and are considered non-responders at 4 months will be re-randomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to a behavioral intervention will begin self-guided CBT for the next 4 months.",[79,74],{"label":97,"type":62,"description":98,"interventionNames":99},"Cognitive Behavioral Therapy then Same Cognitive Behavioral Therapy","Participants randomized to behavioral interventions will all begin with self-guided CBT. If considered responders at 4 months they will continue with self-guided CBT for the next 4 months.",[79],{"label":101,"type":62,"description":102,"interventionNames":103},"Cognitive Behavioral Therapy then New Cognitive Behavioral Therapy","Participants randomized to behavioral interventions will all begin with self-guided CBT. If considered non-responders at 4 months, they will be rerandomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to a behavioral intervention will begin traditional CBT for the next 4 months.",[79],{"label":105,"type":62,"description":106,"interventionNames":107},"Cognitive Behavioral Therapy then Oral Medication","Participants randomized to behavioral interventions will all begin with self-guided CBT. Non-responders at 4 months will be re-randomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to oral medications will select an oral medication for the next 4 months.",[79,65],{"label":109,"type":62,"description":110,"interventionNames":111},"Cognitive Behavioral Therapy then Topical Medication","Participants randomized to behavioral interventions will all begin with self-guided CBT. Non-responders at 4 months will be re-randomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to topical medications will select a topical medication for the next 4 months.",[79,74],[113,118,123],{"type":114,"name":115,"description":116,"armGroupLabels":117,"otherNames":51},"DEVICE","Cognitive Behavioral Therapy (CBT)","Participants will work with study team to begin web-based, self-guided CBT (non-significant risk device) or traditional (one on one) CBT with a therapist (behavioral, not a device).",[101,105,97,109,76,93],{"type":119,"name":120,"description":121,"armGroupLabels":122,"otherNames":51},"DRUG","Oral Medication","Participants will work with their physician to select an oral medication from a list commonly used to treat PDN. Patients will follow standard of care dosing and tapering of the assigned drug.\n\nSerotonin-Norepinephrine Reuptake Inhibitors (SNRI's): Duloxetine, Venlafaxine, Desvenlafaxine Tricyclic Antidepressants (TCAs): Amitriptyline, Nortriptyline Gabapentinoids: Gabapentin, Pregabalin Sodium Channel Blockers: Oxcarbazepine, Lamotrigine, Lacosamide",[105,76,61,67,71,89],{"type":119,"name":124,"description":125,"armGroupLabels":126,"otherNames":51},"Topical Medication","Participants will work with their physician to select a topical medication from a list commonly used to treat PDN.\n\n0.075% capsaicin cream (4 times daily) 4-5% lidocaine patches (1-4 patches every 24 hours)",[109,71,93,81,89,85],[128],{"name":129,"affiliation":5,"role":130},"Brian Callaghan, MD","PRINCIPAL_INVESTIGATOR",[132],{"name":133,"role":134,"phone":135,"phoneExt":51,"email":136},"Fallon Koenig, MS, CCRP","CONTACT","734-936-8778","fakoenig@med.umich.edu",[138,157,173,189,205,218,231,244,260,272,284,300,319,328,340,356,371,387,406,420,426,442,457],{"facility":139,"status":51,"city":140,"state":141,"zip":142,"country":143,"countryCode":144,"cosmosGeoPoint":145,"geoPoint":150,"contacts":151},"Stanford University","Stanford","California","94305","United States","US",{"type":146,"coordinates":147},"Point",[148,149],-122.16608,37.42411,{"lat":149,"lon":148},[152,155],{"name":153,"role":134,"phone":51,"phoneExt":51,"email":154},"Barbara Hung","barbhung@stanford.edu",{"name":156,"role":130,"phone":51,"phoneExt":51,"email":51},"Dong In Sinn",{"facility":158,"status":51,"city":159,"state":160,"zip":161,"country":143,"countryCode":144,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"University of Florida-Jacksonville","Jacksonville","Florida","32209",{"type":146,"coordinates":163},[164,165],-81.65565,30.33218,{"lat":165,"lon":164},[168,171],{"name":169,"role":134,"phone":51,"phoneExt":51,"email":170},"Grace Bienkowski","grace.bienkowski@jax.ufl.edu",{"name":172,"role":130,"phone":51,"phoneExt":51,"email":51},"Joe Chehade",{"facility":174,"status":51,"city":175,"state":176,"zip":177,"country":143,"countryCode":144,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Rush University Medical Center","Chicago","Illinois","60612",{"type":146,"coordinates":179},[180,181],-87.65005,41.85003,{"lat":181,"lon":180},[184,187],{"name":185,"role":134,"phone":51,"phoneExt":51,"email":186},"Bartosz Jacher","Bartosz_Jacher@rush.edu",{"name":188,"role":130,"phone":51,"phoneExt":51,"email":51},"Rabia Malik",{"facility":190,"status":51,"city":191,"state":192,"zip":193,"country":143,"countryCode":144,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"University of Iowa","Iowa City","Iowa","52242",{"type":146,"coordinates":195},[196,197],-91.53017,41.66113,{"lat":197,"lon":196},[200,203],{"name":201,"role":134,"phone":51,"phoneExt":51,"email":202},"Brian Gryzlak","brian-gryzlak@uiowa.edu",{"name":204,"role":130,"phone":51,"phoneExt":51,"email":51},"Marcelo Correia",{"facility":206,"status":51,"city":207,"state":208,"zip":209,"country":143,"countryCode":144,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"Tulane University","New Orleans","Louisiana","70118",{"type":146,"coordinates":211},[212,213],-90.07507,29.95465,{"lat":213,"lon":212},[216],{"name":217,"role":130,"phone":51,"phoneExt":51,"email":51},"Vivian Fonseca",{"facility":219,"status":51,"city":220,"state":221,"zip":222,"country":143,"countryCode":144,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Johns Hopskins University","Baltimore","Maryland","21224",{"type":146,"coordinates":224},[225,226],-76.61219,39.29038,{"lat":226,"lon":225},[229],{"name":230,"role":130,"phone":51,"phoneExt":51,"email":51},"Eva Tseng",{"facility":5,"status":51,"city":232,"state":233,"zip":234,"country":143,"countryCode":144,"cosmosGeoPoint":235,"geoPoint":239,"contacts":240},"Ann Arbor","Michigan","48104",{"type":146,"coordinates":236},[237,238],-83.74088,42.27756,{"lat":238,"lon":237},[241,242],{"name":133,"role":134,"phone":135,"phoneExt":51,"email":136},{"name":243,"role":130,"phone":51,"phoneExt":51,"email":51},"Lynn Ang, MD",{"facility":245,"status":51,"city":246,"state":247,"zip":248,"country":143,"countryCode":144,"cosmosGeoPoint":249,"geoPoint":253,"contacts":254},"Allina Health-Neurosciences Research","Minneapolis","Minnesota","55407",{"type":146,"coordinates":250},[251,252],-93.26384,44.97997,{"lat":252,"lon":251},[255,258],{"name":256,"role":134,"phone":51,"phoneExt":51,"email":257},"Emeryth Beloy","emeryth.beloy@allina.com",{"name":259,"role":130,"phone":51,"phoneExt":51,"email":51},"Goel Vasudha",{"facility":261,"status":51,"city":246,"state":247,"zip":262,"country":143,"countryCode":144,"cosmosGeoPoint":263,"geoPoint":265,"contacts":266},"University of Minnesota","55455",{"type":146,"coordinates":264},[251,252],{"lat":252,"lon":251},[267,270],{"name":268,"role":134,"phone":51,"phoneExt":51,"email":269},"Sarah Hilbert","hilbe010@umn.edu",{"name":271,"role":130,"phone":51,"phoneExt":51,"email":51},"Pitcha Choompongpod",{"facility":273,"status":51,"city":274,"state":247,"zip":275,"country":143,"countryCode":144,"cosmosGeoPoint":276,"geoPoint":280,"contacts":281},"Mayo Clinic Rochester","Rochester","55902",{"type":146,"coordinates":277},[278,279],-92.4699,44.02163,{"lat":279,"lon":278},[282],{"name":283,"role":130,"phone":51,"phoneExt":51,"email":51},"Kamal Shouman",{"facility":285,"status":51,"city":286,"state":287,"zip":288,"country":143,"countryCode":144,"cosmosGeoPoint":289,"geoPoint":293,"contacts":294},"University of Missouri","Columbia","Missouri","65201",{"type":146,"coordinates":290},[291,292],-92.33407,38.95171,{"lat":292,"lon":291},[295,298],{"name":296,"role":134,"phone":51,"phoneExt":51,"email":297},"Megan Burnam-Cole","burnamma@health.missouri.edu",{"name":299,"role":130,"phone":51,"phoneExt":51,"email":51},"Richard Barohn",{"facility":301,"status":51,"city":302,"state":303,"zip":304,"country":143,"countryCode":144,"cosmosGeoPoint":305,"geoPoint":309,"contacts":310},"University of Nebraska","Omaha","Nebraska","68198",{"type":146,"coordinates":306},[307,308],-95.94043,41.25626,{"lat":308,"lon":307},[311,314,317],{"name":312,"role":134,"phone":51,"phoneExt":51,"email":313},"Susan Bubach","susan.burbach@unmc.edu",{"name":315,"role":134,"phone":51,"phoneExt":51,"email":316},"Lisa Kuechenmeister","likuechenmeister@nebraskamed.com",{"name":318,"role":130,"phone":51,"phoneExt":51,"email":51},"Cyrus Desouza",{"facility":320,"status":51,"city":321,"state":321,"zip":322,"country":143,"countryCode":144,"cosmosGeoPoint":323,"geoPoint":327,"contacts":51},"Columbia University","New York","10027",{"type":146,"coordinates":324},[325,326],-74.00597,40.71427,{"lat":326,"lon":325},{"facility":329,"status":51,"city":321,"state":321,"zip":330,"country":143,"countryCode":144,"cosmosGeoPoint":331,"geoPoint":333,"contacts":334},"Will Cornell Medicine","10065",{"type":146,"coordinates":332},[325,326],{"lat":326,"lon":325},[335,338],{"name":336,"role":134,"phone":51,"phoneExt":51,"email":337},"Michele Steinkamp","mls9004@med.cornell.edu",{"name":339,"role":130,"phone":51,"phoneExt":51,"email":51},"Lisa Witkin",{"facility":341,"status":51,"city":342,"state":343,"zip":344,"country":143,"countryCode":144,"cosmosGeoPoint":345,"geoPoint":349,"contacts":350},"University of North Carolina","Chapel Hill","North Carolina","27599",{"type":146,"coordinates":346},[347,348],-79.05584,35.9132,{"lat":348,"lon":347},[351,354],{"name":352,"role":134,"phone":51,"phoneExt":51,"email":353},"Elizabeth Burnett","Elizabeth_ODonohue@med.unc.edu",{"name":355,"role":130,"phone":51,"phoneExt":51,"email":51},"Laura Young",{"facility":357,"status":51,"city":358,"state":343,"zip":359,"country":143,"countryCode":144,"cosmosGeoPoint":360,"geoPoint":364,"contacts":365},"Duke University","Durham","27708",{"type":146,"coordinates":361},[362,363],-78.89862,35.99403,{"lat":363,"lon":362},[366,369],{"name":367,"role":134,"phone":51,"phoneExt":51,"email":368},"Jhoanna Aquino","jhoannazaida.aquino@duke.edu",{"name":370,"role":130,"phone":51,"phoneExt":51,"email":51},"Ranee Chatterjee, MD",{"facility":372,"status":51,"city":373,"state":374,"zip":375,"country":143,"countryCode":144,"cosmosGeoPoint":376,"geoPoint":380,"contacts":381},"Oregon Health & Science University","Portland","Oregon","97239",{"type":146,"coordinates":377},[378,379],-122.67621,45.52345,{"lat":379,"lon":378},[382,385],{"name":383,"role":134,"phone":51,"phoneExt":51,"email":384},"Aly Carlson","carlsaly@ohsu.edu",{"name":386,"role":130,"phone":51,"phoneExt":51,"email":51},"Rodica Busui",{"facility":388,"status":51,"city":389,"state":390,"zip":391,"country":143,"countryCode":144,"cosmosGeoPoint":392,"geoPoint":396,"contacts":397},"University of Pittsburgh","Titusville","Pennsylvania","16354",{"type":146,"coordinates":393},[394,395],-79.67366,41.627,{"lat":395,"lon":394},[398,401,404],{"name":399,"role":134,"phone":51,"phoneExt":51,"email":400},"Autumn Boyer","ARB352@pitt.edu",{"name":402,"role":134,"phone":51,"phoneExt":51,"email":403},"Emily Klawson","ekk15@pitt.edu",{"name":405,"role":130,"phone":51,"phoneExt":51,"email":51},"Holly Thomas",{"facility":407,"status":51,"city":408,"state":409,"zip":410,"country":143,"countryCode":144,"cosmosGeoPoint":411,"geoPoint":415,"contacts":416},"Meharry Medical College","Nashville","Tennessee","37208",{"type":146,"coordinates":412},[413,414],-86.78444,36.16589,{"lat":414,"lon":413},[417],{"name":418,"role":134,"phone":51,"phoneExt":51,"email":419},"Abraham Garcia Ortega","agarcia@mmc.edu",{"facility":421,"status":51,"city":408,"state":409,"zip":422,"country":143,"countryCode":144,"cosmosGeoPoint":423,"geoPoint":425,"contacts":51},"University of Vanderbilt","37235",{"type":146,"coordinates":424},[413,414],{"lat":414,"lon":413},{"facility":427,"status":51,"city":428,"state":429,"zip":430,"country":143,"countryCode":144,"cosmosGeoPoint":431,"geoPoint":435,"contacts":436},"DHR Health Institute for Research and Development","Edinburg","Texas","78539",{"type":146,"coordinates":432},[433,434],-98.16334,26.30174,{"lat":434,"lon":433},[437,440],{"name":438,"role":134,"phone":51,"phoneExt":51,"email":439},"Clarisa Medina","c.medina@dhrhealth.com",{"name":441,"role":130,"phone":51,"phoneExt":51,"email":51},"Marcel Twahirwa",{"facility":443,"status":51,"city":444,"state":429,"zip":445,"country":143,"countryCode":144,"cosmosGeoPoint":446,"geoPoint":450,"contacts":451},"BaylorScott & White University Medical Center","McKinney","75071",{"type":146,"coordinates":447},[448,449],-96.61527,33.19762,{"lat":449,"lon":448},[452,455],{"name":453,"role":134,"phone":51,"phoneExt":51,"email":454},"Priyanka Rana","Priyanka.Rana@BSWHealth.org",{"name":456,"role":130,"phone":51,"phoneExt":51,"email":51},"Dana Bleakney",{"facility":458,"status":51,"city":459,"state":460,"zip":461,"country":143,"countryCode":144,"cosmosGeoPoint":462,"geoPoint":466,"contacts":467},"Essentia Health","Spooner","Wisconsin","54801",{"type":146,"coordinates":463},[464,465],-91.88934,45.82245,{"lat":465,"lon":464},[468,471],{"name":469,"role":134,"phone":51,"phoneExt":51,"email":470},"Nathan Mukai","nathan.mukai@essentiahealth.org",{"name":472,"role":130,"phone":51,"phoneExt":51,"email":51},"Stephen Rostad",{"type":130,"investigatorFullName":474,"investigatorTitle":475,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"Brian Callaghan","Professor of Neurology",[477],{"name":478,"class":6},"Patient-Centered Outcomes Research Institute","100654065","phase-4-modality-choice-before-and-after-failure-for-the-treatment-of-painful-diabetic-neuropathy-100654065",false,"NCT07795593","Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy","Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy (MCPAIN)","MCPAIN","Inclusion Criteria:\n\n* Diabetes\n* Painful Diabetic Neuropathy (confirmed at screening visit)\n* Willing to accept random treatment assignment to any of the proposed interventions\n\nExclusion Criteria:\n\n* Pregnancy or plans to become pregnant during the study\n* History of neuropathy from causes other than diabetes as determined through medical and family history, physical and neurologic examinations\n* HbA1c \\>10%\n* Participation in an experimental medication trial within 3 months of starting the study\n* Undergoing therapy for malignant disease other than basal-cell or squamous-cell skin cancer\n* Medical or psychiatric reason for not being a study candidate according to the site PI's discretion\n* Contraindications preventing trialing two interventions within any of the 3 modalities\n* Cirrhosis of the liver","ALL","18 Years",{"count":490,"type":491},600,"ESTIMATED","INTERVENTIONAL",[494],"PHASE4","The research team will perform a comparative-effectiveness sequential, multiple assignment, randomized trial in painful diabetic neuropathy (PDN) patients for 8 total months, divided into two 4-month stages. 600 participants 18+ with PDN will be enrolled in this study. The main goal is to compare the utility of three modalities (oral, topical, and behavioral) for initial PDN treatment, and to compare the utility of switching modalities versus continuing with the same modality for non-responders. Pain and discontinuation will be assessed weekly, whereas other outcomes will be assessed monthly for 8 months.",[497,498],"Painful Diabetic Neuropathy (PDN)","Diabetic Nephropathies","NOT_YET_RECRUITING","2026-09-25",{"date":502,"type":503},"2026-09-28","ACTUAL",{"date":505,"type":491},"2026-10",{"date":507,"type":491},"2031-10",{"name":5,"class":6},23]