[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497538":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":477,"collaborators":479,"id":483,"slug":484,"hasResults":485,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":485,"sex":491,"minAge":492,"maxAge":493,"enrollmentInfo":494,"targetDuration":30,"studyType":497,"phases":498,"briefSummary":500,"conditions":501,"keywords":503,"overallStatus":49,"whyStopped":30,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":514},{"fullName":5,"class":6},"Piomic Medical","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"COMS One device","ACTIVE_COMPARATOR","The COMS One device is the housing unit for the user controls, displays and functions including embedded software, lithium-ion battery, optical (LEDs) and a magnetic stimulation coil. The COMS One device is reusable (the component can be used on multiple subjects and is cleaned between uses).\n\nThe COMStouch is a sterile single-use component. The COMStouch provides a base and sterile barrier for the COMS One device.\n\nThe COMSfix component is a self-adhesive single-use strap used to hold the COMS One device and COMStouch components in place during treatment.",[13],"Device: COMS One device",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham device","SHAM_COMPARATOR","The sham device is the housing unit for the user controls, displays and functions including embedded software, lithium-ion battery, optical (LEDs) and a magnetic stimulation coil. The sham device is reusable (the component can be used on multiple subjects and is cleaned between uses).\n\nThe COMStouch is a sterile single-use component. The COMStouch provides a base and sterile barrier for the sham device.\n\nThe COMSfix component is a self-adhesive single-use strap used to hold the sham device and COMStouch components in place during treatment.",[19],"Device: Sham device",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","The COMS One device incorporates technologies for optical and magnetic stimulation. The optical stimulation component is designed to emit light by two types of light emitting diodes (LEDs) in the wavelength of 660 nm (red) and 830 nm (near infrared) range of the electromagnetic spectra. The magnetic stimulation component is generated by a coil emitting pulse modulated magnetic fields in the extremely low frequency (ELF) range of the electromagnetic spectra. The COMS One is a lightweight, portable device. The device is locally applied via a single use disposable component (COMStouch) that provides a base and sterile barrier for the unit. The device is attached via a single use strap (COMSfix). The device has been slightly adapted in order to make sure blinding is achieved\u002Fmaintained. The specific feature that has been modified for the purpose of blinding is sensor detecting whether the device is lying on the skin.",[9],[26],"Concurrent Optical and Magnetic Stimulation",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"The Sham device is a lightweight, portable device. The device is applied via a single use disposable component (COMStouch) that provides a base and sterile barrier for the unit. The device is attached via a single use strap (COMSfix). The device has been slightly adapted in order to make sure blinding is achieved\u002Fmaintained. The specific features that have been modified for the purposes of blinding include the following: 1) therapeutic output, and 2) sensor detecting whether the device is lying on the skin.",[15],null,[32],{"name":33,"affiliation":34,"role":35},"Aksone Nouvong, DPM","University of California, Los Angeles","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":30,"email":41},"Rejelle Williams","CONTACT","+41 44 244 19 78","williams@piomic.com",{"name":43,"role":39,"phone":44,"phoneExt":30,"email":45},"Bernard Laurel","+1-855-574-6642","laurel@piomic.com",[47,67,84,100,115,127,142,154,166,174,189,207,223,233,248,257,273,289,305,311,326,342,358,367,383,396,412,431,447,462],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Titan Clinical Research","RECRUITING","Mesa","Arizona","85202","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-111.82264,33.42227,{"lat":59,"lon":58},[62,65],{"name":63,"role":39,"phone":30,"phoneExt":30,"email":64},"Noreen Rana","nrana.alas@viableresearch.org",{"name":66,"role":35,"phone":30,"phoneExt":30,"email":30},"Yadwinder Dhillon, MD",{"facility":68,"status":49,"city":69,"state":51,"zip":70,"country":53,"countryCode":54,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Southern Arizona VA Health Care System","Tucson","85723",{"type":56,"coordinates":72},[73,74],-110.92648,32.22174,{"lat":74,"lon":73},[77,82],{"name":78,"role":39,"phone":79,"phoneExt":80,"email":81},"Lorrie Mills","520-792-1450","1-4068","Lorrie.Mills@va.gov",{"name":83,"role":35,"phone":30,"phoneExt":30,"email":30},"Jodi Walters, DPM",{"facility":85,"status":49,"city":86,"state":87,"zip":88,"country":53,"countryCode":54,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Center for Clinical Research Inc.","Castro Valley","California","94546",{"type":56,"coordinates":90},[91,92],-122.08635,37.6941,{"lat":92,"lon":91},[95,98],{"name":96,"role":39,"phone":30,"phoneExt":30,"email":97},"Maria Peralta","Maria@ccr-trials.com",{"name":99,"role":35,"phone":30,"phoneExt":30,"email":30},"Alexander Reyzelman, DPM",{"facility":101,"status":49,"city":102,"state":87,"zip":103,"country":53,"countryCode":54,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"VA Central California Healthcare","Fresno","93703",{"type":56,"coordinates":105},[106,107],-119.77237,36.74773,{"lat":107,"lon":106},[110,114],{"name":111,"role":39,"phone":112,"phoneExt":30,"email":113},"Viraj Pandit, MD","559-225-6100","viraj.pandit@va.gov",{"name":111,"role":35,"phone":30,"phoneExt":30,"email":30},{"facility":116,"status":49,"city":102,"state":87,"zip":117,"country":53,"countryCode":54,"cosmosGeoPoint":118,"geoPoint":120,"contacts":121},"Limb Preservation Platform, Inc.","93710",{"type":56,"coordinates":119},[106,107],{"lat":107,"lon":106},[122,125],{"name":123,"role":39,"phone":30,"phoneExt":30,"email":124},"Destiny Blackstone","Destiny@LPPresearch.com",{"name":126,"role":35,"phone":30,"phoneExt":30,"email":30},"Shawn M. Cazzell, DPM",{"facility":128,"status":49,"city":129,"state":87,"zip":130,"country":53,"countryCode":54,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Angel City Research, Inc.","Los Angeles","90010",{"type":56,"coordinates":132},[133,134],-118.24368,34.05223,{"lat":134,"lon":133},[137,140],{"name":138,"role":39,"phone":30,"phoneExt":30,"email":139},"Maira Jackson","maira@angelcityresearch.com",{"name":141,"role":35,"phone":30,"phoneExt":30,"email":30},"Felix Sigal, DPM",{"facility":143,"status":49,"city":129,"state":87,"zip":144,"country":53,"countryCode":54,"cosmosGeoPoint":145,"geoPoint":147,"contacts":148},"UCLA Ronald Regan - Department of Surgery","90095",{"type":56,"coordinates":146},[133,134],{"lat":134,"lon":133},[149,152],{"name":150,"role":39,"phone":30,"phoneExt":30,"email":151},"Marco Morcos","MMorcos@mednet.ucla.edu",{"name":153,"role":35,"phone":30,"phoneExt":30,"email":30},"Vincent Rowe, MD",{"facility":85,"status":49,"city":155,"state":87,"zip":156,"country":53,"countryCode":54,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"San Francisco","94115",{"type":56,"coordinates":158},[159,160],-122.41942,37.77493,{"lat":160,"lon":159},[163,165],{"name":164,"role":39,"phone":30,"phoneExt":30,"email":97},"Maria Paralta",{"name":99,"role":35,"phone":30,"phoneExt":30,"email":30},{"facility":85,"status":49,"city":155,"state":87,"zip":167,"country":53,"countryCode":54,"cosmosGeoPoint":168,"geoPoint":170,"contacts":171},"94117",{"type":56,"coordinates":169},[159,160],{"lat":160,"lon":159},[172,173],{"name":96,"role":39,"phone":30,"phoneExt":30,"email":97},{"name":99,"role":35,"phone":30,"phoneExt":30,"email":30},{"facility":175,"status":49,"city":176,"state":87,"zip":177,"country":53,"countryCode":54,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"ILD Research Center","Vista","92081",{"type":56,"coordinates":179},[180,181],-117.24254,33.20004,{"lat":181,"lon":180},[184,187],{"name":185,"role":39,"phone":30,"phoneExt":30,"email":186},"Eric Martinez","eric@ildresearch.com",{"name":188,"role":35,"phone":30,"phoneExt":30,"email":30},"Dean Vayser, DPM",{"facility":190,"status":49,"city":191,"state":192,"zip":193,"country":53,"countryCode":54,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Bay Pines VA Healthcare System","Bay Pines","Florida","33744",{"type":56,"coordinates":195},[196,197],-82.77816,27.81419,{"lat":197,"lon":196},[200,205],{"name":201,"role":39,"phone":202,"phoneExt":203,"email":204},"Ashlee Tavernier","727 398 6661","17842","Ashlee.Tavernier@va.gov",{"name":206,"role":35,"phone":30,"phoneExt":30,"email":30},"Melissa Abercrombie, DMP",{"facility":208,"status":49,"city":209,"state":192,"zip":210,"country":53,"countryCode":54,"cosmosGeoPoint":211,"geoPoint":215,"contacts":216},"MCR Health","Bradenton","34208",{"type":56,"coordinates":212},[213,214],-82.57482,27.49893,{"lat":214,"lon":213},[217,221],{"name":218,"role":39,"phone":219,"phoneExt":30,"email":220},"Susan Chamberlain, RN","941-920-9870","schamberlain@mcr.health",{"name":222,"role":35,"phone":30,"phoneExt":30,"email":30},"Chrisbel Dafeampekor, DPM",{"facility":224,"status":225,"city":226,"state":192,"zip":227,"country":53,"countryCode":54,"cosmosGeoPoint":228,"geoPoint":232,"contacts":30},"University of Florida Health Jacksonville","WITHDRAWN","Jacksonville","32209",{"type":56,"coordinates":229},[230,231],-81.65565,30.33218,{"lat":231,"lon":230},{"facility":234,"status":49,"city":235,"state":192,"zip":236,"country":53,"countryCode":54,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"Clever Medical Research LLC","Miami","33126",{"type":56,"coordinates":238},[239,240],-80.19366,25.77427,{"lat":240,"lon":239},[243,246],{"name":244,"role":39,"phone":30,"phoneExt":30,"email":245},"Margarita Hernandez","mhernandez@clevermedresearch.com",{"name":247,"role":35,"phone":30,"phoneExt":30,"email":30},"Heliodoro Ruiz, MD",{"facility":249,"status":225,"city":250,"state":192,"zip":251,"country":53,"countryCode":54,"cosmosGeoPoint":252,"geoPoint":256,"contacts":30},"The Angel Medical Research Corporation","Miami Lakes","33016",{"type":56,"coordinates":253},[254,255],-80.30866,25.90871,{"lat":255,"lon":254},{"facility":258,"status":49,"city":259,"state":192,"zip":260,"country":53,"countryCode":54,"cosmosGeoPoint":261,"geoPoint":265,"contacts":266},"Vital Medical Research","Sweetwater","33174",{"type":56,"coordinates":262},[263,264],-80.37311,25.76343,{"lat":264,"lon":263},[267,271],{"name":268,"role":39,"phone":269,"phoneExt":30,"email":270},"Alejandro Morlan, APRN","305-703-4414","alejandro.m@vitalmedicalresearch.com",{"name":272,"role":35,"phone":30,"phoneExt":30,"email":30},"Deeva Frankel, DPM",{"facility":274,"status":49,"city":275,"state":276,"zip":277,"country":53,"countryCode":54,"cosmosGeoPoint":278,"geoPoint":282,"contacts":283},"Aiyan Diabetes Center","Augusta","Georgia","30907",{"type":56,"coordinates":279},[280,281],-81.97484,33.47097,{"lat":281,"lon":280},[284,287],{"name":285,"role":39,"phone":30,"phoneExt":30,"email":286},"Vishnu Gardasu","office@aiyandiabetescenter.com",{"name":288,"role":35,"phone":30,"phoneExt":30,"email":30},"Janaki Nadarajah, DPM",{"facility":290,"status":49,"city":291,"state":292,"zip":293,"country":53,"countryCode":54,"cosmosGeoPoint":294,"geoPoint":298,"contacts":299},"Northwestern University Feinberg School of Medicine","Chicago","Illinois","60611",{"type":56,"coordinates":295},[296,297],-87.65005,41.85003,{"lat":297,"lon":296},[300,303],{"name":301,"role":39,"phone":30,"phoneExt":30,"email":302},"Tarifa Adam","tarifaadam2025@u.northwestern.edu",{"name":304,"role":35,"phone":30,"phoneExt":30,"email":30},"Robert Galiano, MD",{"facility":306,"status":225,"city":291,"state":292,"zip":307,"country":53,"countryCode":54,"cosmosGeoPoint":308,"geoPoint":310,"contacts":30},"Rush University","60612",{"type":56,"coordinates":309},[296,297],{"lat":297,"lon":296},{"facility":312,"status":49,"city":313,"state":292,"zip":314,"country":53,"countryCode":54,"cosmosGeoPoint":315,"geoPoint":319,"contacts":320},"Gateway Clinical Trials","O'Fallon","62269",{"type":56,"coordinates":316},[317,318],-89.91121,38.59227,{"lat":318,"lon":317},[321,324],{"name":322,"role":39,"phone":30,"phoneExt":30,"email":323},"Valerie Anderson","valerie@podiatry1st.com",{"name":325,"role":35,"phone":30,"phoneExt":30,"email":30},"Christopher Anderson, DPM",{"facility":327,"status":49,"city":328,"state":329,"zip":330,"country":53,"countryCode":54,"cosmosGeoPoint":331,"geoPoint":335,"contacts":336},"Curalta Clinical Trials","Westwood","New Jersey","07675",{"type":56,"coordinates":332},[333,334],-74.03264,40.99121,{"lat":334,"lon":333},[337,340],{"name":338,"role":39,"phone":30,"phoneExt":30,"email":339},"Radhika Gajera","Rgajera@curalta.com",{"name":341,"role":35,"phone":30,"phoneExt":30,"email":30},"Vincent Giacalone, DPM",{"facility":343,"status":49,"city":344,"state":345,"zip":346,"country":53,"countryCode":54,"cosmosGeoPoint":347,"geoPoint":351,"contacts":352},"Veteran Affairs of WNY Healthcare System","Buffalo","New York","14215",{"type":56,"coordinates":348},[349,350],-78.87837,42.88645,{"lat":350,"lon":349},[353,356],{"name":354,"role":39,"phone":30,"phoneExt":30,"email":355},"Ann Galla","Ann.Galla@va.gov",{"name":357,"role":35,"phone":30,"phoneExt":30,"email":30},"Andrew Puckett, DPM",{"facility":359,"status":225,"city":360,"state":345,"zip":361,"country":53,"countryCode":54,"cosmosGeoPoint":362,"geoPoint":366,"contacts":30},"Northwell Comprehensive Wound Healing Center","Lake Success","11042",{"type":56,"coordinates":363},[364,365],-73.71763,40.77066,{"lat":365,"lon":364},{"facility":368,"status":49,"city":369,"state":370,"zip":371,"country":53,"countryCode":54,"cosmosGeoPoint":372,"geoPoint":376,"contacts":377},"UNC Medical Center","Chapel Hill","North Carolina","27514",{"type":56,"coordinates":373},[374,375],-79.05584,35.9132,{"lat":375,"lon":374},[378,381],{"name":379,"role":39,"phone":30,"phoneExt":30,"email":380},"Kari Walls","kawalls@email.unc.edu",{"name":382,"role":35,"phone":30,"phoneExt":30,"email":30},"Stephen Heisler, DPM",{"facility":384,"status":49,"city":385,"state":386,"zip":387,"country":53,"countryCode":54,"cosmosGeoPoint":388,"geoPoint":392,"contacts":393},"The Ohio State University","Columbus","Ohio","43210",{"type":56,"coordinates":389},[390,391],-82.99879,39.96118,{"lat":391,"lon":390},[394],{"name":395,"role":35,"phone":30,"phoneExt":30,"email":30},"Jonathan Wisler, MD",{"facility":397,"status":49,"city":398,"state":399,"zip":400,"country":53,"countryCode":54,"cosmosGeoPoint":401,"geoPoint":405,"contacts":406},"UPMC McKeesport","McKeesport","Pennsylvania","15132",{"type":56,"coordinates":402},[403,404],-79.86422,40.34785,{"lat":404,"lon":403},[407,410],{"name":408,"role":39,"phone":30,"phoneExt":30,"email":409},"Chelsea Fredrick","chf168@pitt.edu",{"name":411,"role":35,"phone":30,"phoneExt":30,"email":30},"Sashwati Roy, PhD",{"facility":413,"status":49,"city":414,"state":415,"zip":416,"country":53,"countryCode":54,"cosmosGeoPoint":417,"geoPoint":421,"contacts":422},"Vanderbilt University Medical Center - Vanderbilt Wound Center","Nashville","Tennessee","37232",{"type":56,"coordinates":418},[419,420],-86.78444,36.16589,{"lat":420,"lon":419},[423,426,429],{"name":424,"role":39,"phone":30,"phoneExt":30,"email":425},"Celia Núñez","celia.m.nunez@vumc.org",{"name":427,"role":39,"phone":30,"phoneExt":30,"email":428},"Mena Azer","mena.n.azer@vumc.org",{"name":430,"role":35,"phone":30,"phoneExt":30,"email":30},"Mark Iafrati, MD",{"facility":432,"status":49,"city":433,"state":434,"zip":435,"country":53,"countryCode":54,"cosmosGeoPoint":436,"geoPoint":440,"contacts":441},"Richard C. Galperin DPM PA","Dallas","Texas","75208",{"type":56,"coordinates":437},[438,439],-96.80667,32.78306,{"lat":439,"lon":438},[442,445],{"name":443,"role":39,"phone":30,"phoneExt":30,"email":444},"Leisa Guerrero","drgfoc@yahoo.com",{"name":446,"role":35,"phone":30,"phoneExt":30,"email":30},"Richard C. Galperin, DPM",{"facility":448,"status":49,"city":449,"state":434,"zip":450,"country":53,"countryCode":54,"cosmosGeoPoint":451,"geoPoint":455,"contacts":456},"HCA Healthcare Houston Medical Center","Houston","77004",{"type":56,"coordinates":452},[453,454],-95.36327,29.76328,{"lat":454,"lon":453},[457,460],{"name":458,"role":39,"phone":30,"phoneExt":30,"email":459},"Brianna De Roche","Brianna.DeRoche@hcahealthcare.com",{"name":461,"role":35,"phone":30,"phoneExt":30,"email":30},"Kristofer Charlton-Ouw, MD",{"facility":463,"status":49,"city":464,"state":434,"zip":465,"country":53,"countryCode":54,"cosmosGeoPoint":466,"geoPoint":470,"contacts":471},"Futuro Clinical Trials, LLC","McAllen","78501",{"type":56,"coordinates":467},[468,469],-98.23001,26.20341,{"lat":469,"lon":468},[472,475],{"name":473,"role":39,"phone":30,"phoneExt":30,"email":474},"Pedro Gonzalez","Pedro@futuroct.com",{"name":476,"role":35,"phone":30,"phoneExt":30,"email":30},"Joseph Caporusso, DPM",{"type":478,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[480],{"name":481,"class":482},"NAMSA","OTHER","100497538","trial-to-evaluate-the-safety-and-effectiveness-of-treatment-with-coms-one-device-in-subjects-with-diabetic-foot-ulcers-100497538",false,"NCT05758545","Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers","Concurrent Optical and Magnetic Stimulation (COMS) for Treatment of Refractory Diabetic Foot Ulcer; a Prospective Randomized, Sham-controlled, Double-blinded, Pivotal Clinical Trial","Mavericks","Inclusion Criteria:\n\n1. Subjects are male or female, ≥22 and ≤90 years of age\n2. Female subjects of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) starting at screening and throughout the duration of their study participation.\n3. The participant (or LAR if applicable) must be able to understand and sign the informed consent form (ICF) and comply with requirements set in the protocol including trial visits, trial treatment and dressing regimens and compliance with required offloading device (if applicable)\n4. Type 1 or Type 2 diabetes mellitus\n5. Presence of one full-thickness DFU located at or below the malleoli (If the subject has more than one DFU that meets eligibility criteria, the investigator will designate one DFU as the target DFU to be treated in the trial)\n6. Wagner Grade 1 or 2 (without bone exposure)\n7. There is a minimum 2 cm margin between the target DFU and any other ulcer on that same foot, post-debridement\n8. Target DFU duration \\>30 days and \\\u003C52 weeks\n9. Target DFU area between 0.5 - 25 cm2 at screening (Target DFU is ≥ 0.5cm2 after debridement at start of Run-In Phase)\n10. Adequate vascular perfusion of the target limb (same limb as where the target DFU is located) as evidenced by: either a skin perfusion pressure (SPP) measurement of ≥30mmHg OR an ankle-brachial index (ABI) \\>0.7 but less than 1.2 or a toe-brachial index (TBI) \\>0.4 but less than 1.1 or a transcutaneous oxygen pressure (TcPO2) \\>40mmHg\n\nExclusion Criteria:\n\n1. Known pregnancy or lactating\n2. Active skin cancer, a history of skin cancer or any other localized cancer, precancerous lesions or large moles in the areas to be treated.\n3. Subject who is taking any medications the Investigator believes may interfere with healing of the target DFU\n4. Subject who is currently undergoing treatment for an active systemic infection, including osteomyelitis\n5. Wagner Grade 3, 4 or 5\n6. Participation in another trial with investigational drug or device within the 30 days preceding and during the present trial\n7. Any co-morbid medical condition which places the subject at unreasonable risks in the opinion of the Investigator\n8. Subject has chronic renal insufficiency requiring dialysis (end stage renal disease)\n9. Subject is being treated with systemic corticosteroids (prednisone, dexamethasone, hydrocortisone, methylprednisolone, or similar) \\>10mg\u002Fday for more than 10 days or any dose \\>30 days\n10. For subjects in the 2-Week Run-In Phase: more than 30% closure of target DFU at Screening Run-In Phase Visit I or Randomization\u002FBaseline Visit or more than 50% closure of target DFU between the 2 Week Historical Period and Randomization\u002FBaseline Visit (measured post-debridement)\n11. For subjects in the 4-Week Run-In Phase: more than 30% closure of target DFU at Screening Run-In Visit II or between Screening Run-In Phase Visit II and Randomization\u002FBaseline Visit or more than 50% closure of target DFU between Screening Run-In Phase Visit I and Randomization\u002FBaseline Visit (measured post-debridement)\n12. Blood chemistry or counts values as follows (based on subject's medical files):\n\n    1. Pre-albumin \\\u003C10 mg\u002FdL OR albumin \\\u003C2.8 g\u002FdL\n    2. Serum BUN \\>60 mg\u002FdL\n    3. Serum creatinine \\>4.0 mg\u002FdL\n    4. WBC \\\u003C2.0 x 109\u002FL\n    5. Hemoglobin \\\u003C8.0 g\u002FdL\n    6. Absolute neutrophil \\\u003C1.0 x 109\u002FL\n    7. Platelet count \\\u003C50 x 109\u002FL\n    8. HbA1C \\>12%","ALL","22 Years","90 Years",{"count":495,"type":496},450,"ESTIMATED","INTERVENTIONAL",[499],"NA","The purpose of this clinical trial is to evaluate the safety and effectiveness of the treatment with the COMS One device in subjects with refractory diabetic foot ulcers (DFUs). The prospective randomized, double-blinded, sham-controlled trial is designed to demonstrate superiority of wound closure of the COMS One device to a sham-control device through 24 weeks post-application, when each is administered in conjunction with standard of care (SOC) in the treatment of DFUs.",[502],"Diabetic Foot Ulcer",[504],"Refractory Diabetic Foot Ulcer (DFU)","2026-02-12",{"date":507,"type":508},"2026-02-17","ACTUAL",{"date":510,"type":508},"2023-06-19",{"date":512,"type":496},"2027-06-19",{"name":5,"class":6},30]