[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05950659":3,"trial-entities:NCT05950659":123,"trial-summary:NCT05950659":128},{"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":23,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":41,"secondary_outcomes":45,"sex":60,"minimum_age":61,"maximum_age":17,"healthy_volunteers":62,"eligibility_criteria":63,"std_ages":92,"locations":95,"central_contacts":111,"overall_officials":116,"references":121,"see_also_links":122},"NCT05950659","IRB00527262","WIREDUP: Wearable Insoles for Recurrent Diabetic Ulcer Prevention","Prevention of Foot Ulcer Recurrence in Individuals Who Are at High-risk for Diabetic Foot Complications Using the Orpyx Sensory Insole System: a Multisite, Randomized, Controlled Trial","RECRUITING","2029-05-01","2026-07","2026-07-14","2026-04-22","Johns Hopkins University","OTHER",true,"The primary aim of this study is to demonstrate the impact of the Orpyx® Sensory Insoles (Orpyx Medical Technologies Inc., Calgary AB, Canada) (\"Orpyx\" or \"the Company\") as an adjunct to the standard of care (SOC), as compared to SOC alone, on reducing plantar ulceration incidence in individuals who are at risk for developing diabetic foot complications.\n\nThe secondary aims of this study are to evaluate participant quality of life, participant engagement, and economic impact, including cost-effectiveness and cost-utility. The study will also use the unique data set collected (plantar pressure, temperature, step count, movement and adherence feedback) to identify foot-loading histories that either lead to or prevent the development of ulceration in the diabetic foot.",null,[19,20,21,22],"Diabetes","Peripheral Neuropathy","Diabetic Foot","Diabetic Foot Ulcer",[24,25,26],"Remote Patient Monitoring","Sensor-based Monitoring","Sensory Insoles","INTERVENTIONAL","PREVENTION",[30],"NA",{"count":32,"type":33},400,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DEVICE","Orpyx Sensory Insole System","The Orpyx Sensory Insoles System uses Orpyx Sensory Technology: a powered limb overload warning technology intended for monitoring physiologic parameters, such as plantar pressure, temperature, motion, and adherence, and providing real-time cues for pressure offloading",[40],"Intervention",[42],{"measure":43,"timeFrame":44},"Plantar ulcer recurrence","Baseline to End of Study (12 months)",[46,50,54,57],{"measure":47,"description":48,"timeFrame":49},"Severity of Ulcer Recurrence","Severity of ulcer recurrence will be quantified using the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system.","From Baseline to End of Study Visit (12 months)",{"measure":51,"description":52,"timeFrame":53},"Participant quality of life","Health-related quality of life will be evaluated based on patient responses on the EuroQol- 5 Dimension (EQ-5D), Patient Interpretation of Neuropathy (PIN), and Modified Diabetic Foot-Care Behavior (MDFCB) ratings.","These will be evaluated at Baseline, 6 months, and 12 months (end of study).",{"measure":55,"description":56,"timeFrame":44},"Cost-effectiveness","A prospective cost-effectiveness and cost-utility analysis will be performed comparing the experimental and control arms.",{"measure":58,"description":59,"timeFrame":44},"Participant engagement","For the Intervention arm only, this is measured by the number of successful interactions between the Remote Patient Monitoring (RPM) team and participant.","ALL","18 Years",false,{"inclusion":64,"exclusion":80,"raw_text":91},[65,66,67,68,69,70,71,72,73,74,75,76,77,78,79],"Diagnosed Type 1 or 2 diabetes","Clinically diagnosed neuropathy via Neuropathy Monofilament Test (Appendix A)","Qualification as a \"high-risk participant,\" meaning a recent history (\\\u003C12 months) of a healed diabetic neuropathic ulceration on the weight-bearing surface of one or both feet (this includes the plantar distal toe surface)","Complete healing of any previous foot ulcers, as defined by complete re-epithelialization of that ulcer which is confirmed by two medical exams that occur at least two weeks apart (screening visit and baseline study visit)","Ability to walk independently (without use of wheelchair) for 30 steps. Use of a walker or cane is acceptable as long as the participant can walk for at least 30 steps.","Aged \\>18 years","ABI \\> 0.6 or TBI \\> 0.4 or palpable pulses or evidence of healing in the last 2 months. If ABI \\\u003C 0.4, the patient's vascular lab studies (ABI, TBI, pulse volume recordings) will be reviewed by the study PI and a co-I vascular surgeon at USC.","Subject is willing and able to maintain the required offloading (as applicable for the location of the healed ulcer)","Subject is willing and able to wear the Orpyx Sensory Insoles during ambulatory activity and at home during waking hours, and for a minimum of 5 hours per day","Amputations, if present, are compatible with the use of insoles at physician discretion (e.g. Transmetatarsal Amputation (TMA) are acceptable)","Above ankle amputation","Amputations not compatible with the insole, per physician discretion","Foot deformities or amputations that require surgical intervention as the next step in standard of care, and that the study footwear and device would not adequately address (to be adjudicated by an outside review panel).","Brannock-measured foot size \\> Men's 14 (Women's 12)","Physician discretion",[81,82,83,84,85,86,87,88,89,90],"Active ulcer or presence of other open chronic wound (on foot or leg), regardless of etiology (e.g., vasculitis, neoplasms, or hematological disorders)","Dementia","Psychiatric illness or social situations that would limit compliance with the study","Significant cardiopulmonary, severe imbalance, or other systemic disease limiting the participant's ability to walk at least 30 steps or to stand for an amount of time equal to or greater than five (5) minutes (self-reported)","Current participation in another clinical investigation of a similar medical device designed to offload or prevent diabetic foot ulcer formation; or participation in such a study within 30 days prior to study enrollment, per physician discretion","Current enrollment in any other remote patient pedal monitoring (RPPM) program","Osteomyelitis or gangrene of the lower extremity","Uncorrected plantar Charcot neuroarthropathy","Bunion which would predispose ulcer formation (clinician discretion)","Extreme equinus","Inclusion Criteria:\n\n* Diagnosed Type 1 or 2 diabetes\n* Clinically diagnosed neuropathy via Neuropathy Monofilament Test (Appendix A)\n* Qualification as a \"high-risk participant,\" meaning a recent history (\\\u003C12 months) of a healed diabetic neuropathic ulceration on the weight-bearing surface of one or both feet (this includes the plantar distal toe surface)\n* Complete healing of any previous foot ulcers, as defined by complete re-epithelialization of that ulcer which is confirmed by two medical exams that occur at least two weeks apart (screening visit and baseline study visit)\n* Ability to walk independently (without use of wheelchair) for 30 steps. Use of a walker or cane is acceptable as long as the participant can walk for at least 30 steps.\n* Aged \\>18 years\n* ABI \\> 0.6 or TBI \\> 0.4 or palpable pulses or evidence of healing in the last 2 months. If ABI \\\u003C 0.4, the patient's vascular lab studies (ABI, TBI, pulse volume recordings) will be reviewed by the study PI and a co-I vascular surgeon at USC.\n* Subject is willing and able to maintain the required offloading (as applicable for the location of the healed ulcer)\n* Subject is willing and able to wear the Orpyx Sensory Insoles during ambulatory activity and at home during waking hours, and for a minimum of 5 hours per day\n* Amputations, if present, are compatible with the use of insoles at physician discretion (e.g. Transmetatarsal Amputation (TMA) are acceptable)\n\nExclusion Criteria:\n\n* Active ulcer or presence of other open chronic wound (on foot or leg), regardless of etiology (e.g., vasculitis, neoplasms, or hematological disorders)\n* Dementia\n* Psychiatric illness or social situations that would limit compliance with the study\n* Significant cardiopulmonary, severe imbalance, or other systemic disease limiting the participant's ability to walk at least 30 steps or to stand for an amount of time equal to or greater than five (5) minutes (self-reported)\n* Current participation in another clinical investigation of a similar medical device designed to offload or prevent diabetic foot ulcer formation; or participation in such a study within 30 days prior to study enrollment, per physician discretion\n* Current enrollment in any other remote patient pedal monitoring (RPPM) program\n* Osteomyelitis or gangrene of the lower extremity\n* Uncorrected plantar Charcot neuroarthropathy\n* Bunion which would predispose ulcer formation (clinician discretion)\n* Extreme equinus\n* At the start of V1, and prior to randomization, the subject no longer meets the entrance criteria (inclusion and exclusion)\n* Above ankle amputation\n* Amputations not compatible with the insole, per physician discretion\n* Foot deformities or amputations that require surgical intervention as the next step in standard of care, and that the study footwear and device would not adequately address (to be adjudicated by an outside review panel).\n* Brannock-measured foot size \\> Men's 14 (Women's 12)\n* Physician discretion",[93,94],"ADULT","OLDER_ADULT",[96],{"facility":97,"status":8,"city":98,"state":99,"zip":100,"country":101,"contacts":102,"geoPoint":108},"Johns Hopkins Hospital","Baltimore","Maryland","21287","United States",[103],{"name":104,"role":105,"phone":106,"email":107},"Shannon Hammerlund, MPH","CONTACT","667-306-9479","shamme11@jh.edu",{"lat":109,"lon":110},39.29038,-76.61219,[112],{"name":113,"role":105,"phone":114,"email":115},"Emily Bray","+1 (855) 996-7799","emily.bray@orpyx.com",[117],{"name":118,"affiliation":119,"role":120},"Caitlin Hicks, MD","John's Hopkins University","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":124,"biomarkers":127},[125,126,20],"Diabetes Mellitus","Diabetic foot",[],{"nct_id":4,"found":15,"summary":129,"prompt_version":138},{"design":130,"status":131,"heading":6,"summary":132,"follow_up":133,"word_count":134,"commitments":135,"compensation":136,"drugs_mentioned":137},"This study is an interventional study planning to enroll 400 participants. It compares the Orpyx Sensory Insole System plus standard care to standard care alone.","completed","This study is testing the Orpyx® Sensory Insoles System to see if it can help prevent diabetic foot ulcers (sores) from coming back. These special insoles monitor things like pressure and temperature in your feet and give you real-time feedback to help you relieve pressure. The study wants to see if using these insoles along with standard care is better than standard care alone at preventing new ulcers over 12 months. You might be able to join if you have type 1 or 2 diabetes, nerve damage in your feet (neuropathy), and have had a healed diabetic foot ulcer in the last year. The study is also looking at how the insoles affect your quality of life and the economic impact.","Participants will be followed from baseline to the end of the study, which is 12 months, to measure plantar ulcer recurrence.",121,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]