[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hu Zhicheng\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100634898","periosteal-distraction-with-skin-grafting-for-dfu-100634898",false,"NCT07545668","Periosteal Distraction With Skin Grafting for DFU","Periosteal Distraction Combined With Skin Grafting for the Treatment of Diabetic Foot Ulcers: A Prospective, Randomized, Controlled Study","Inclusion Criteria:\n\n* Age ≥18 years on the day of signing informed consent.\n* Diagnosed with type 2 diabetes mellitus.\n* Diabetic foot ulcer persisting for ≥2 weeks.\n* Wagner grade 2 or 3; or post-amputation (Wagner grade 4-5) wound requiring skin grafting.\n* Wound area ≥3 cm².\n* Brachial-ankle index between 0.71 and 1.30.\n* Hemodynamically stable with routine examinations indicating tolerance to surgery.\n* Mentally competent, able to follow medical advice, and willing to attend scheduled follow-up visits.\n* Understand and voluntarily sign informed consent to participate in this trial.\n\nExclusion Criteria:\n\n* Poorly controlled hyperglycemia (e.g., HbA1c \\>12.0%).\n* Immunosuppression due to underlying disease, long-term immunosuppressive therapy, or high-dose glucocorticoids (e.g., ≥40 mg prednisone or equivalent daily for ≥2 weeks) during screening.\n* Preexisting conditions affecting wound healing (e.g., malignancy, autoimmune disease).\n* Severe uncontrolled systemic disease or acute systemic infection; concomitant severe cardiac, pulmonary, or cerebral disease.\n* Psychiatric disorders.\n* Deemed unsuitable for inclusion by the investigator.\n* Pregnancy, unwillingness to use adequate contraception in women of childbearing potential, lactation, or planning pregnancy within 1 month after study completion.\n* Active osteomyelitis in the target ulcer without adequate debridement and\u002For antibiotic treatment.\n* Significant uncorrected biomechanical deformity expected to severely affect graft survival and function.\n* Active bleeding or significant coagulation abnormality.\n* Previous participation in this study at any time.","ALL","18 Years","85 Years",{"count":20,"type":21},104,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is a single-center, prospective, randomized controlled trial aimed at evaluating whether periosteal distraction combined with autologous split-thickness skin grafting can significantly improve graft survival rate at postoperative day 14 compared with skin grafting alone in patients with diabetic foot ulcers (Wagner grade 2-3 or post-amputation). A total of 104 eligible patients will be randomly assigned to either the experimental group (periosteal distraction + skin grafting, n=52) or the control group (skin grafting alone, n=52). Secondary outcomes include time to complete epithelialization, wound healing quality (BWAT score at 3 months), ulcer recurrence rate (at 6 months), foot function (AOFAS score), quality of life (DFS-SF score), and safety profile. This study aims to address the critical clinical bottleneck of poor graft survival in ischemic wound environments, providing a novel, minimally invasive, and synergistic treatment paradigm for diabetic foot ulcers.",[27,28],"Diabetic Foot Disease","Wound Healing","NOT_YET_RECRUITING","2026-04-21",{"date":32,"type":33},"2026-04-22","ACTUAL",{"date":35,"type":21},"2026-05-01",{"date":37,"type":21},"2029-12-31",{"name":39,"class":40},"Hu Zhicheng","OTHER",""]