[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transtibial-amputation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transtibial-amputation":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,50,82,112,139],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100638105","clinical-evaluation-of-the-access-socket-flexible-socket-for-transtibial-prosthesis-100638105",false,"NCT07592325","Clinical Evaluation of the Access Socket Flexible Socket for Transtibial Prosthesis","AS-TT","Inclusion Criteria:\n\n* Unilateral or bilateral transtibial amputation\n* Currently fitted with a definitive carbon rigid socket\n* Any residual-limb shape\n* Any etiology\n* Able to understand simple instructions, read, write, and provide informed consent - or able to be accompanied by a trusted person in case of inability to read\u002Fwrite autonomously\n* Provided free written informed consent\n* Aged 18 years or older\n* Affiliated to a social security system\n\nExclusion Criteria:\n\n* Use of hydroalcoholic solution (HAS) for socket donning\n* Currently fitted with a provisional socket\n* Neurological pathology limiting capacity to participate in activities\n* Orthopedic pathology limiting capacity to participate in activities\n* Pregnant or breastfeeding women\n* Minors\n* Persons not under legal protection or unable to express consent\n* Persons under guardianship or curatorship\n* Persons under judicial protection","ALL","18 Years",{"count":19,"type":20},25,"ESTIMATED","INTERVENTIONAL",[23],"NA","Transtibial amputation significantly impacts patient autonomy and quality of life, primarily due to the limitations of conventional rigid sockets, which restrict comfort and joint range of motion. The Access Socket (AS) is an innovative prosthetic socket combining a rigid carbon-fiber structure in key load-bearing areas with flexible urethane-resin (ProtheFLEX®) zones in regions typically rigid in conventional sockets. This hybrid design aims to improve comfort and pressure distribution while preserving the mechanical properties required for ambulation.\n\nThe AS has already demonstrated benefits in transfemoral amputees and is now reimbursed in France for that population. A preliminary uncontrolled study in 12 transtibial amputees suggested significant improvements in perceived function, comfort, satisfaction, and mobility.\n\nThis multicenter, randomized, open-label, two-arm crossover study aims to compare the (AS) with the standard rigid socket (RS) in 25 adults with transtibial amputation. Participants will wear each socket for approximately 4 weeks (after a 1-2 week adaptation period) in a randomized order. The primary outcome is the Patient Specific Functional Scale (PSFS). Secondary outcomes include comfort (SCS), satisfaction (OPUS), psychosocial adjustment (TAPES-R), mobility (PLUS-M), prosthesis utility (PEQ-U), and the proportion of patients electing to keep the AS at study completion.",[26,27],"Transtibial Amputation","Lower Limb Amputation Below Knee",[29,30,31,32,33,34,35,36,37],"Transtibial prosthesis","Prosthetic socket","Flexible socket","Access Socket","Comfort","Quality of life","Rehabilitation","cross over trial","Patient Specific Scale","RECRUITING","2026-05-13",{"date":41,"type":42},"2026-05-18","ACTUAL",{"date":44,"type":42},"2026-04-27",{"date":46,"type":20},"2027-10-30",{"name":48,"class":49},"Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est","OTHER",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":16,"minAge":17,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100515264","improving-socket-fit-in-female-and-male-veterans-with-transtibial-and-transfemoral-amputation-100515264","NCT05989243","Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation","Improving Socket Fit in Female and Male Veterans With Transtibial and TransfemoralAmputation","SocketFit","Inclusion Criteria:\n\n* The investigators will enroll up to 40 Veterans\n\n  * 20 with unilateral transtibial amputation\n  * 20 with unilateral transfemoral amputation who are at or above a K2 Medicare functional classification level (MFCL) and who are 18-65 years old\n* All participants will have no current problems with their prosthesis or residual limb, and be at least 6-months post-amputation\n* Participants will be at or above a K2 MFCL, defined as a person who has the ability or potential for ambulation with the ability to traverse low level environmental barriers such as curbs, stairs, or uneven surfaces, typical of the limited community ambulator\n\nExclusion Criteria:\n\n* Cardiovascular, pulmonary, or neurological disease or disorder or requirement for an assistive device for their unaffected leg (i.e. orthosis, cane)",true,"65 Years",{"count":61,"type":20},40,"OBSERVATIONAL","The investigators do not yet know how a prosthetic socket with adjustable panels affects the performance of people with a lower limb amputation compared to a conventional prosthetic socket. The primary objective of this study is to compare an adjustable and conventional prosthetic socket and use this information to determine the optimal socket that would improve rehabilitation and function in people with lower limb amputation.",[26,65],"Transfemoral Amputation",[67,68,69,70],"Biomechanics","Kinematics","Walking","Prostheses","2026-04-20",{"date":73,"type":42},"2026-04-23",{"date":75,"type":42},"2022-01-31",{"date":77,"type":20},"2027-03-31",{"name":79,"class":80},"VA Office of Research and Development","FED",1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100362134","optimizing-gait-rehabilitation-for-veterans-with-non-traumatic-lower-limb-amputation-100362134","NCT03995238","Optimizing Gait Rehabilitation for Veterans With Non-traumatic Lower Limb Amputation","Optimizing Gait Rehabilitation for Veterans With Non-Traumatic Lower Limb Amputation","GEM","Inclusion Criteria:\n\n* Unilateral, non-traumatic, transtibial amputation\n* Diabetes mellitus and\u002For peripheral artery disease\n* Able to ambulate in the community without assistive device\n* Step length asymmetry during walking (\\>1.0 asymmetry index.)\n* 6 months since amputation\n\nExclusion Criteria:\n\n* Unstable heart condition\n* Including unstable angina, uncontrolled cardiac dysrhythmia, acute myocarditis, hypertension, and acute pericarditis\n* Acute systemic infection\n* Active cancer treatment\n* Traumatic or cancer related amputation etiology","40 Years","89 Years",{"count":93,"type":20},54,[23],"The population of older Veterans with non-traumatic lower limb amputation is growing. Following lower limb amputation, asymmetrical movements persist during walking and likely contribute to disabling sequelae including secondary pain conditions, poor gait efficiency, impaired physical function, and compromised skin integrity of the residual limb. This study seeks to address chronic gait asymmetry by evaluating the efficacy of two error-manipulation gait training programs to improve gait symmetry for Veterans with non-traumatic lower limb amputation. Additional this study will evaluate the potential of error-manipulation training programs to improve secondary measures of disability and residual limb skin health. Ultimately, this study aims to improve conventional prosthetic rehabilitation for Veterans with non-traumatic amputation through gait training programs based in motor learning principles, resulting in improved gait symmetry and lower incidence of long-term disability after non-traumatic lower limb amputation.",[26,97,98],"Peripheral Artery Disease","Diabetes Mellitus",[100,35,101,102,97],"Amputation","Gait Training","Diabetes","2026-04-06",{"date":105,"type":42},"2026-04-13",{"date":107,"type":42},"2019-10-09",{"date":109,"type":20},"2026-10-31",{"name":79,"class":80},2,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":21,"phases":121,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":81},"100609561","phase-1-epidermal-sensors-for-wireless-and-enhanced-amputee-skin-tracking-e-sweat-part-1-100609561","NCT07216183","Epidermal Sensors for Wireless and Enhanced Amputee Skin Tracking (E-SWEAT) Part 1","Inclusion Criteria:\n\n* Be 18 years or older\n* Have a unilateral lower limb amputee (below the knee). The tibial length on the residual limb must be greater than half of the length of the tibial on the unaffected side\n* Have an amputation that occurred over 2 years ago\n* Have at least 1 year of experience using your prosthetic leg\n* Have used the current socket for at least 6 months without a significant skin issue or major modification\n* Be able to comfortably walk 6 mins (with prosthetic legs) without pausing to rest\n* Be willing to come to North Carolina State University's Centennial Campus to participate in research and be photographed while doing research activities\n\nExclusion Criteria:\n\n* Have a cognitive or visual impairment that affects the participant's ability to provide informed consent or to follow simple instructions during the experiments\n* Have any neuropathy observed on the residual limb\n* Experience numbness, tingling, muscle weakness, and\u002For pain in your residual limb\n* Weigh more than 300lbs\n* Do not want to take photos\n* Are pregnant or plan to get pregnant\n* Are allergic to latex, which is often contained in medical tapes.\n* If you are using medication to control sweat on your residual limb, and your medical provider does not think that it is OK to avoid these medications for 48 hours.","75 Years",{"count":120,"type":20},16,[122],"PHASE1","The goal of this clinical trial is to 1) demonstrate the feasibility of monitoring pressure, temperature, and lactic acid density of sweat inside the prosthetic socket, and 2) verify the relationship between mechanical pressure and Lactic acid density of sweat for lower limb amputees among transtibial amputees. The main questions it aims to answer are:\n\n* Is it feasible to reliably monitor pressure, temperature, and lactic acid density inside the prosthetic sockets simultaneously?\n* Will the lactic acid density increase with higher pressure exposure? The participants are expected to wear the newly developed E-SWEAT system on their residual limb and are exposed to two activities, walk which generate mechanical load on the residual limb, and a yoga post - birddog, which does not generate mechanical loading on the residual limb. The E-SWEAT will measure pressure, temperature, and lactic acid density of sweat during these tasks.",[26],[126,127,128,129],"sweat biomarker","prosthetic socket","pressure ulcer","residual limb health","2025-10-09",{"date":132,"type":42},"2025-10-14",{"date":134,"type":42},"2025-09-16",{"date":136,"type":20},"2029-07-30",{"name":138,"class":49},"North Carolina State University",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":146,"maxAge":59,"enrollmentInfo":147,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":81},"100607969","early-phase-1-feasibility-study-evaluating-the-safety-and-effectiveness-of-magnetic-bead-tracking-system-when-used-with-a-bionic-external-prosthesis-100607969","NCT07195461","Feasibility Study Evaluating the Safety and Effectiveness of Magnetic Bead Tracking System When Used With a Bionic External Prosthesis","A Feasibility Study Evaluating the Magnetic Bead Tracking System and Its Safety and Effectiveness When Used With a Bionic External Prosthesis to Improve Prosthetic Controllability for Persons With Transtibial Amputation","Inclusion Criteria:\n\n* Male or Female age 22-65 at the time of surgery.\n* The patient must already have an existing unilateral or bilateral transtibial amputation requiring revision or a medical condition requiring performance of a unilateral or bilateral transtibial amputation.\n* If the patient does not already have an amputation, the patient must have undergone independent consultation with a lower extremity surgical specialist to ensure they have exhausted all limb salvage options prior to undergoing amputation, as well as a psychiatric evaluation to ensure appropriate capacity and volition, and a pain medicine evaluation to ensure that all pain control options outside of amputation have been addressed.\n* The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above, as determined by a trained and certified prosthetist and confirmed by study investigators, through use of a patient history and physical examination).\n* The patient must have adequate soft tissue bulk and muscle mass present in the operative limb to support appropriate wound healing.\n* The patient must demonstrate volitional activation of the muscles into which magnet placement is intended.\n* In the opinion of the investigator, the patient must likely be able to tolerate the pressure of a prosthetic socket during ambulation post-operatively.\n* In the opinion of the investigator, the patient must have absence of any physical limitations, addictive diseases or underlying medical conditions that may preclude the patient from being a good study candidate.\n* The patient must have willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.\n* The patient must have willingness and ability to provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients with any active skin disease in the subject limb.\n* Patients with severe comorbidity, atypical skeletal anatomy, or poor general physical\u002Fmental health that, in the opinion of the Investigator, will not allow the patients to be a good study candidate (i.e., other disease processes, mental capacity, substance abuse, shortened life. expectancy, vulnerable patient population, etc.).\n* Patients with the following concurrent diseases: active infection or dormant bacteria, metabolic bone disease and\u002For metastatic lesions in the residual tibia.\n* Patients weighing over 285 lbs. with the prosthesis, at time of screening.\n* Patients for whom skeletal growth is not complete. Completed skeletal growth is defined through the finding of generally closed epiphyseal zones on X-ray.\n* Patients with advanced atrophic muscle and\u002For compromised soft tissue coverage in the operative limb.\n* Patients with evidence of or a documented history of severe peripheral vascular disease, diabetes mellitus (type I or type II), skin diseases, neuropathy or neuropathic disease and severe phantom pain, or osteoporosis, such that, in the opinion of the investigator, will not allow the patient to be a good study candidate.\n* Patient with a history of systemically administered corticosteroids, immune-suppressive therapy or chemotherapy drugs within six (6) months of implant surgery.\n* Patients with a known need of future MRIs.\n* Patients currently involved in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of this clinical study.\n* Active smokers will be excluded from candidacy; those patients willing to undergo tobacco cessation will need to be completely abstinent from tobacco use for at least 6 weeks preoperatively.\n* Women who are pregnant, lactating or planning a pregnancy during the first twelve (12) months of the post-surgical follow-up.\n* Patient having an allergy to any component of the device.\n* Patients with concurrent illness, disability or geographical residence that would hamper attendance at required study visits.","22 Years",{"count":148,"type":20},3,[150],"EARLY_PHASE1","The investigation is an early feasibility study in up to 5 subjects, in which the primary objective is to capture preliminary safety and effectiveness information on the Magnetic Bead Tracking system.",[153,26],"Transtibial Amputee",[155,156,157,158,159],"transtibial","amputation","amputee","magnet","prosthesis","2025-09-19",{"date":162,"type":42},"2025-09-26",{"date":164,"type":42},"2025-09-11",{"date":166,"type":20},"2026-04",{"name":168,"class":169},"MuscleMetrix, LLC","INDUSTRY"]