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    "path": "/trials/NCT07493889",
    "result": {"pageContext":{"pagePath":"/trials/NCT07493889","trial":{"nct_id":"NCT07493889","brief_title":"Electrical Stimulation for Clinical and Psychosocial Outcomes in Chronic Pressure Injuries","official_title":"Healing Beyond the Wound: Clinical and Psychosocial Outcomes of Monophasic Electrical Stimulation in Pressure Injuries - A Randomized Controlled Pilot Study","about_trial":"Pressure injuries are chronic wounds that frequently occur in immobilized patients and are associated with delayed healing, reduced quality of life, and significant psychological burden. Electrical stimulation has been suggested as an adjunctive therapy to promote wound healing by enhancing angiogenesis, improving cell migration, and restoring local bioelectric fields.\n\nThis randomized controlled pilot study aims to evaluate the clinical and psychosocial effects of high-voltage monophasic rectangular pulsed current (HVMRPC) in patients with chronic pressure injuries. Twenty adult patients with stage II-IV pressure injuries that did not respond to at least four weeks of standard wound care are randomly assigned to receive either HVMRPC in addition to standard wound care or standard wound care alone.\n\nThe intervention consists of electrical stimulation applied to the periwound area five times per week for six weeks. Clinical outcomes include changes in wound size and wound severity measured with the Pressure Ulcer Scale for Healing (PUSH). Psychosocial outcomes include anxiety and depression levels measured with the Hospital Anxiety and Depression Scale (HADS) and health-related quality of life measured with EQ-5D-5L.\n\nThe study investigates whether electrical stimulation provides additional benefits beyond standard wound care in improving both wound healing parameters and psychological well-being in patients with chronic pressure injuries.","age_from":18,"age_to":null,"ais_a":false,"ais_b":false,"ais_c":false,"ais_d":false,"ais_e":false,"time_since_injury_from":null,"time_since_injury_from_unit":null,"time_since_injury_to":null,"time_since_injury_to_unit":null,"healthy_volunteers":true,"inclusion_criteria":["NOT have cardiac pacemaker or implanted electrical device"],"study_type":"interventional","allocation":"Randomized","brief_description":"Pressure injuries are chronic wounds that frequently occur in immobilized patients and are associated with delayed healing, reduced quality of life, and significant psychological burden. Electrical stimulation has been suggested as an adjunctive therapy to promote wound healing by enhancing angiogenesis, improving cell migration, and restoring local bioelectric fields.\n\nThis randomized controlled pilot study aims to evaluate the clinical and psychosocial effects of high-voltage monophasic rectangular pulsed current (HVMRPC) in patients with chronic pressure injuries. Twenty adult patients with stage II-IV pressure injuries that did not respond to at least four weeks of standard wound care are randomly assigned to receive either HVMRPC in addition to standard wound care or standard wound care alone.\n\nThe intervention consists of electrical stimulation applied to the periwound area five times per week for six weeks. Clinical outcomes include changes in wound size and wound severity measured with the Pressure Ulcer Scale for Healing (PUSH). Psychosocial outcomes include anxiety and depression levels measured with the Hospital Anxiety and Depression Scale (HADS) and health-related quality of life measured with EQ-5D-5L.\n\nThe study investigates whether electrical stimulation provides additional benefits beyond standard wound care in improving both wound healing parameters and psychological well-being in patients with chronic pressure injuries.","detailed_description":null,"final_testing_performed":"6 weeks","version_id":2,"emsci_trial":false,"curation_status":"uncurated","overall_recruitment_status":"ended","primary_intervention":{"id":5,"name":"Technology","parent_id":null,"icon_name":"technology"},"primary_benefit":{"id":10,"name":"Skin health","parent_id":null,"icon_name":"skin"},"sex":"All","injury_level_from":"C1","injury_level_to":"S5","start_date":"2023-01-01","organization":"Gaziler Physical Medicine and Rehabilitation Education and Research Hospital","benefits":[{"id":5,"name":"General health","parent_id":null,"icon_name":"general-health"},{"id":6,"name":"Mental health and psychosocial factors","parent_id":null,"icon_name":"mental-health"},{"id":7,"name":"Pain","parent_id":null,"icon_name":"pain-relief"},{"id":10,"name":"Skin health","parent_id":null,"icon_name":"skin"}],"injuries":[],"interventions":[{"id":5,"name":"Technology","parent_id":null,"icon_name":"technology"}],"outcome_measures":[{"id":48,"name":"European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L)","short_name":"EQ-5D-5L","pivot":{"trial_id":7906,"outcome_measure_id":48}},{"id":67,"name":"Hospital Anxiety and Depression Scale (HADS)","short_name":"HADS","pivot":{"trial_id":7906,"outcome_measure_id":67}},{"id":169,"name":"Pain Visual Analog Scale (VAS)","short_name":"VAS","pivot":{"trial_id":7906,"outcome_measure_id":169}}],"recovery_mechanisms":[],"published_at":"2026-03-30T06:49:26.000000Z","modified_at":"2026-03-30T06:49:26.000000Z"},"layout":"trial"}},
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