[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486191":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":45,"centralContacts":54,"locations":63,"responsibleParty":83,"collaborators":86,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":34,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":34,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":124,"overallStatus":66,"whyStopped":34,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"University of the Punjab","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Control; Standard-of-care management","ACTIVE_COMPARATOR","Saline dressing will be done as a routine care management.",[13],"Other: Control; Standard-of-care management",{"label":15,"type":16,"description":17,"interventionNames":18},"Only PRP injection","EXPERIMENTAL","Only PRP will be injected at the wound site.",[19],"Biological: Only PRP injection",{"label":21,"type":16,"description":22,"interventionNames":23},"PRP + SVF injection","SVF pellet mixed with PRP will be injected at the wound site after adjusting number of cells.",[24],"Biological: PRP + SVF injection",{"label":26,"type":16,"description":27,"interventionNames":28},"PRP + ASCs injection","Cultured ASCs mixed with PRP will be injected at the wound site after adjusting number of cells.",[29],"Biological: PRP + ASCs injection",[31,35,39,42],{"type":6,"name":9,"description":32,"armGroupLabels":33,"otherNames":34},"Patients will undergo conventional wound care management.",[9],null,{"type":36,"name":15,"description":37,"armGroupLabels":38,"otherNames":34},"BIOLOGICAL","Only PRP injected \u002F cm2 intradermally at the border zone \\& inside of wound surface bed.",[15],{"type":36,"name":21,"description":40,"armGroupLabels":41,"otherNames":34},"Uncultured cells (SVF) along PRP were mixed, transferred to 1 cc syringes and injected \u002F cm2 intradermally at the border zone \\& inside of wound surface bed.",[21],{"type":36,"name":26,"description":43,"armGroupLabels":44,"otherNames":34},"Cultured ASCs along PRP were mixed, transferred to 1 cc syringes and injected \u002F cm2 intradermally at the border zone \\& inside of wound surface bed.",[26],[46,50],{"name":47,"affiliation":48,"role":49},"Azra Mehmood, PhD","Center of Excellence in Molecular Biology (CEMB, University of the Punjab, Lahore","PRINCIPAL_INVESTIGATOR",{"name":51,"affiliation":52,"role":53},"Sheikh Riazuddin, PhD","Jinnah Burn and Reconstructive Surgery Center (JB&RSC), Lahore","STUDY_DIRECTOR",[55,59],{"name":47,"role":56,"phone":57,"phoneExt":34,"email":58},"CONTACT","+92-333-4107008","azra_mehmood@hotmail.com",{"name":60,"role":56,"phone":61,"phoneExt":34,"email":62},"Amna Arif, M.Phil.","+92-333-4161068","amnaarif.qureshi@gmail.com",[64],{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Stem Cell Laboratory, Jinnah Burn and Reconstructive Surgery Center (JB&RSC)","RECRUITING","Lahore","Punjab Province","54550","Pakistan","PK",{"type":73,"coordinates":74},"Point",[75,76],74.35071,31.558,{"lat":76,"lon":75},[79],{"name":80,"role":56,"phone":81,"phoneExt":34,"email":82},"Dr. Moazzam Nazeer Tarar, Plastic Surgeon MBBS\u002F FRCS","+92-300-8423139","mntarar@gmail.com",{"type":49,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Azra Mehmood","Associate Professor",[87,90,92],{"name":88,"class":89},"Centre of Excellence in Molecular Biology, University of the Punjab, Lahore","UNKNOWN",{"name":91,"class":6},"Higher Education Commission (Pakistan)",{"name":93,"class":94},"Jinnah Burn and Reconstructive Surgery Centre, Lahore","OTHER_GOV","100486191","phase-1-efficacy-of-adipose-tissue-derived-stem-cells-for-the-treatment-of-diabetic-foot-ulcers-100486191",false,"NCT05610865","Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers","Autologous Adipose Tissue Derived Stromal Vascular Fraction Versus Cultured Adipose Derived Stem Cells for the Treatment of Chronic Diabetic Wounds","Inclusion Criteria:\n\n* Type 1 or Type 2 Diabetes Mellitus\n* Age 20-60 years (Male\u002FFemale)\n* Body mass index 20-30 kg\u002Fm2\n* Suitable for liposuction\n* Condition or Disease: Diabetic Neuropathy\n* Wound Type: Chronic foot ulcer\n* Approx. wound area: 2 cm2 - 8 cm2\n* Wound Condition should be of Wagner's grade I (Limited to soft tissue)\n* Duration of wound persistence: 6-24 Weeks\n* Transcutaneous oxygen pressure \\> 30 mmHg, and an ankle brachial pressure index \\> 0.5.\n* Already following an adequate off-loading method\n* Provided signed informed consent\n\nExclusion Criteria:\n\n* Uncontrolled hyperglycemia (HbAlc \\> 9%)\n* Presence of severe clinical sign of infection\n* Inability to tolerate off-loading, and poor prognosis diseases including malignant tumors.\n* Serious chronic disease i.e hepatic, heart, renal, pulmonary diseases\n* Patients with critical limb ischemia and osteomylitis\n* Withdrawal of informed consent","ALL","20 Years","60 Years",{"count":106,"type":107},28,"ESTIMATED","INTERVENTIONAL",[110],"PHASE1","The aim of this study is to evaluate the therapeutic efficacy of uncultured adipose derived stromal vascular fraction (SVF) and cultured adipose derived stem cells (ASCs) both supplemented with platelet rich plasma (PRP) to treat chronic diabetic foot ulcers. It will increase the pragmatic potential of both types of cells as PRP is rich in survival and chemotactic factors. Moreover, the autologous nature of the proposed study will ensure safety of its use in diabetic patients and will unveil the more effective therapeutic option for treatment of foot ulcer wounds.",[113,114,115,116,117,118,119,120,121,122,123],"Diabetic Foot Ulcer","Diabetes Mellitus","Diabetic Foot","Diabetic Foot Infection","Diabetic Foot Ulcer Neuropathic","Foot Ulcer Due to Type 1 Diabetes Mellitus","Foot Ulcer Due to Type 2 Diabetes Mellitus","Foot Ulcer","Diabetes Complications","Chronic Diabetic Ulcer of Left Foot","Chronic Diabetic Foot Ulcer of Right Foot",[125],"Stromal vascular fraction (SVF), Adipose derived stem cells (ASCs), Diabetic foot ulcer (DFU), Platelet rich plasma (PRP)","2024-12-30",{"date":128,"type":129},"2024-12-31","ACTUAL",{"date":131,"type":129},"2020-11-20",{"date":133,"type":107},"2025-12",{"name":5,"class":6},1]