[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07653165":3,"trial-entities:NCT07653165":94,"trial-summary:NCT07653165":102},{"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":24,"study_type":33,"primary_purpose":34,"phases":35,"enrollment_info":37,"interventions":40,"primary_outcomes":47,"secondary_outcomes":52,"sex":60,"minimum_age":61,"maximum_age":61,"healthy_volunteers":15,"eligibility_criteria":62,"std_ages":68,"locations":72,"central_contacts":81,"overall_officials":82,"references":86,"see_also_links":87},"NCT07653165","HydroPrep-01","Use of Hydroprep Wound Therapy With Motion Negative Pressure Therapy for Treatment of Chronic Lower Extremity Wounds","A Prospective, Open-Label, Single-Arm Clinical Trial Evaluating the Efficacy of Hydroprep Wound Therapy Followed by Motion Negative Pressure Wound Therapy in the Treatment of Chronic Lower Extremity Wounds","ENROLLING_BY_INVITATION","2026-12-31","2026-06","2026-06-17","2026-04-15","West Boca Center for Wound Healing","OTHER",false,"Use of a motorized waterjet to debride wounds to improve healing outcomes.","Hydroprep is a powered waterjet of saline solution used to debride, remove and surgically clean an open wound of any type to improve its ability to heal. The device may also be used to prepare a wound prior to application of a tissue product or a skin graft from the patient. Between treatments, the use of a negative pressure suction portable unit will be used to improve the healing outcome of the wound.",[19,20,21,22,23],"Chronic Lower Leg Ulcer","Diabetic Lower Extremity Ulcers","Pressure Injuries","Traumatic Wounds and Injuries","Surgical Wounds",[25,26,27,28,29,30,31,32],"Chronic Wounds","Debridement","Negative Pressure Wound Therapy","NPWT","Acute Wounds","Diabetic Ulcers","Venous Ulcers","Wounds","INTERVENTIONAL","TREATMENT",[36],"NA",{"count":38,"type":39},50,"ESTIMATED",[41],{"type":42,"name":43,"description":44,"armGroupLabels":45},"DEVICE","Motion NPWT","Negative Pressure application",[46],"Treatment Arm",[48],{"measure":49,"description":50,"timeFrame":51},"Percent Area Reduction of Wound Size","PAR reduction","28 days",[53,57],{"measure":54,"description":55,"timeFrame":56},"\"Graft Ready State\"","Time to achieve target wound to a Graft-ready status","Within 28 days",{"measure":58,"description":59,"timeFrame":51},"Number of Negative Pressure Dressing Applications","Actual number of times the NPWT dressing was changed prior to discontinuation","ALL",null,{"inclusion":63,"exclusion":65,"raw_text":67},[64],"Any chronic lower extremity wound greater than 30 days duration.",[66],"Active infection or previous tissue grafting.","Inclusion Criteria:\n\n* Any chronic lower extremity wound greater than 30 days duration.\n\nExclusion Criteria:\n\n* Active infection or previous tissue grafting.",[69,70,71],"CHILD","ADULT","OLDER_ADULT",[73],{"facility":13,"city":74,"state":75,"zip":76,"country":77,"geoPoint":78},"Coconut Creek","Florida","33073","United States",{"lat":79,"lon":80},26.25175,-80.17894,[],[83],{"name":84,"affiliation":13,"role":85},"Eric J Lullove, DPM","PRINCIPAL_INVESTIGATOR",[],[88,91],{"label":89,"url":90},"MedAxis, LLC","http:\u002F\u002Fwww.medaxis.com",{"label":92,"url":93},"MIMOSA Oxygen Thermography Device","http:\u002F\u002Fwww.mimosadiagnostics.com",{"nct_id":4,"conditions":95,"biomarkers":101},[96,20,97,98,99,22,100],"Chronic ulcer of left lower leg","Pressure Sore","Stasis ulcer","Surgical wound","Wound",[],{"nct_id":4,"found":15,"summary":61,"prompt_version":61}]