[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-foot-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-foot-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,69,91,120,143],{"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",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100629100","detection-of-diabetic-foot-skin-damage-using-plantar-mechanical-parameters-100629100","NCT07470255","Detection of Diabetic Foot Skin Damage Using Plantar Mechanical Parameters","An Exploratory Study on the Detection of Diabetic Foot Skin Damage Using Quantitative Mechanical Parameters of Plantar Skin","Inclusion Criteria:\n\n* For healthy one: Fasting blood glucose \\\u003C 6.1 mmol\u002FL and glycated hemoglobin \\\u003C 6.0%, with no history of diabetes; Foot condition: normal appearance of both feet, without wounds, deformities, trauma, infections, or dermatological disorders; voluntary participation in this study with signed informed consent.\n* For diabetic one: Confirmation of type 1 or type 2 diabetes mellitus as defined by the World Health Organization (WHO) diagnostic standards; Diagnosis of diabetic foot disease\\* consistent with the criteria established by the International Working Group on the Diabetic Foot (IWGDF); Voluntary participation in the present study with provision of signed informed consent.\n\nExclusion Criteria:\n\n* For healthy one: (1) History of foot surgery, trauma, or fractures resulting in skin scars or irreversible cutaneous damage; (2) Active chronic dermatological conditions affecting skin integrity, such as tinea pedis, eczema, or psoriasis; (3) Vascular diseases of the lower extremities (e.g., arteriosclerosis obliterans) causing muscular or cutaneous atrophy in the feet; (4) Systemic diseases impacting the skin or connective tissues, including systemic sclerosis, rheumatoid arthritis, or vasculitis; (5) Prolonged engagement in heavy physical labor or professional sports leading to abnormal thickening or hyperkeratosis of the plantar skin; (6) Presence of extensive, hyperkeratotic lesions (e.g., calluses, corns) or wounds at the measurement site impairing probe contact accuracy; (7) Inability to cooperate or diagnosed psychiatric disorders; (8) Investigator-determined unsuitability for the study or inability to comply with protocol requirements.\n* For diabetic one: (1) Uncontrolled severe acute foot infections; (2) Dermatological conditions that interfere with measurement procedures; (3) Irreversible foot skin damage due to non-diabetic etiologies such as trauma or surgical intervention; (4) Coexisting systemic disorders (excluding diabetes) that compromise skin elasticity, including systemic sclerosis, rheumatoid arthritis, or vasculitis; (5) History of above-knee amputation on the measured foot; (6) Inability to cooperate or presence of psychiatric disorders; (7) Investigator-determined ineligibility due to non-compliance concerns or unsuitability for study participation.",true,"80 Years",{"count":51,"type":21},200,"OBSERVATIONAL","Diabetes represents one of the major chronic diseases, with diabetic ulcers being a significant adverse prognosis. Approximately 80% of lower limb amputations are attributed to diabetic foot ulcers, which constitute a primary cause of patient disability and mortality, while also imposing a substantial burden on healthcare systems. Although standardized Western medical protocols for diabetic foot management exist, clinical outcomes remain suboptimal. The amputation rate due to diabetic foot ulcers continues to rise annually, underscoring the urgent need for novel and effective interventions to address this condition.\n\nQuantitative assessment of cutaneous biomechanical parameters may indirectly reflect the cumulative damage inflicted by diabetes on foot tissues. Such evaluation provides critical guidance for predicting susceptibility to recurrent ulceration and determining the necessity of enhanced offloading strategies to prevent ulcer development. By applying specific mechanical loads to the skin and measuring deformation, rebound characteristics, and displacement dynamics under pressure, it becomes possible to quantitatively evaluate parameters such as elastic modulus and viscoelastic properties.\n\nThis case-control study aims to investigate the feasibility of utilizing plantar skin quantitative mechanical parameters as objective biomarkers for biomechanical impairment in diabetic foot. Furthermore, it seeks to establish a standardized operating procedure (SOP) for quantitative measurements tailored to diabetic foot scenarios. The study is designed to bridge critical evidence gaps between theoretical consensus and clinically applicable quantitative tools, demonstrating clear innovation and potential clinical value.",[27,55,56],"Diabete Mellitus","Mechanical Factor",[27,55,58,59],"Mechanical factor","plantar skin","2026-03-12",{"date":62,"type":33},"2026-03-13",{"date":64,"type":21},"2026-04-01",{"date":66,"type":21},"2028-04-01",{"name":68,"class":40},"Peking University Third Hospital",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":87,"leadSponsor":89,"locationsCount":4},"100612323","development-and-application-of-a-decision-making-aid-tool-for-amputation-surgery-in-diabetic-foot-patients-based-on-the-ottawa-decision-support-framework-100612323","NCT07252089","Development and Application of a Decision-Making Aid Tool for Amputation Surgery in Diabetic Foot Patients Based on the Ottawa Decision Support Framework","Impact of Decision Support Tools on Amputation Decisions in Diabetic Foot Patients: A Quasi-Experimental Study","Inclusion Criteria:\n\n* Diabetic foot ulcers with Wagner grade 4 or higher gangrene. Diabetic foot ulcers with Wagner grade 3 accompanied by severe infection or systemic symptoms; severe local infections, or chronic osteomyelitis causing functional impairment of the limb.\n\nPatients with lower extremity vascular disease showing progression despite systemic treatment.\n\nIWGDF stage 3 severe infections (characterized by loss of protective sensation or peripheral arterial disease, with at least one of the following: history of foot ulcer, lower limb amputation, or end-stage renal disease).\n\nExclusion Criteria:\n\n* History of psychiatric disorders with inability to cooperate during communication.\n\nConcomitant severe complications.",{"count":77,"type":21},80,[24],"To verify whether amputation decision-making aids can alleviate the decisional dilemma in diabetic foot patients.",[27],[82],"Diabetic Foot Amputation Decision-Making Aid Tool","2025-11-19",{"date":85,"type":33},"2025-11-26",{"date":35,"type":21},{"date":88,"type":21},"2026-10-31",{"name":90,"class":40},"Shiwen Hong",{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100593264","implementation-of-a-diabetic-foot-prevention-strategy-in-primary-care-implanta-study-100593264","NCT07004179","Implementation of a Diabetic Foot Prevention Strategy in Primary Care (iMplanta Study)","Implementation of a Diabetic Foot Prevention Strategy in Primary Care: Study Protocol for Two-arm Cluster Randomised Controlled Trial (iMplanta Study)","iMplanta","Inclusion Criteria:\n\n* Diagnosis of type 1 or type 2 diabetes mellitus.\n* Aged 18 years or older.\n* Attending nursing consultations at participating primary care centers during the study period.\n\nExclusion Criteria:\n\n* Patients with gestational diabetes.\n* Patients with diabetic foot ulcers prior to the start of the study.\n* Patients with lower limb amputations prior to the start of the study.",{"count":100,"type":21},1520,[24],"The goal of this two-arm cluster randomised controlled trial (RCT) is to evaluate the effectiveness of a new implementation strategy based on the ImM model for the Protocol of assistance to the person with diabetic foot (PAPDF) of the Balearic Islands Health Service in reducing complications of diabetic foot, compared to the current implementation strategy, in the primary care centers of Majorca. As secondary objectives we aim 1. To determine the reach of the implementation strategy in the GAPM primary care centers, 2.To compare the effectiveness of the PAPDF versus usual care in preventing diabetic foot complications, 3. To identify the number of healthcare professionals adhering to the implementation strategy and 4. To assess the sustainability of the implementation strategy over time.",[27,104],"Diabetic Foot Ulcer (DFU)",[106,107,108,109],"Diabetic foot","Implementation Sciencie","Prevention","Primary Care","2025-06-25",{"date":112,"type":33},"2025-06-29",{"date":114,"type":21},"2025-09-01",{"date":116,"type":21},"2026-12-22",{"name":118,"class":40},"University of the Balearic Islands",1,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":127,"targetDuration":129,"studyType":52,"phases":4,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":119},"100575863","identification-of-pathogenic-bacteria-of-diabetes-foot-ulcer-100575863","NCT06777810","Identification of Pathogenic Bacteria of Diabetes Foot Ulcer","Genetic Identification and Quantitative Analysis of Pathogenic Bacteria of Diabetic Foot Ulcer Infection","Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. Gender: males and females\n3. Patients diagnosed with diabetic foot infection with an infected wound\n4. It can provide sufficient infected wound samples (≥5mm³ infected wound tissue samples or ≥100μL infected wound secretions) and can be used for detection and analysis of gene chips\n5. No history of antibiotic therapy prior to sampling (within 4 weeks) or known failure to respond to antibiotic therapy (failure to respond to ≥2 antibiotics)\n6. Fully understand the nature, significance, possible benefits, possible inconveniences or potential risks of this research; Understand the study procedure, participate voluntarily and be willing to complete the entire study process, and sign the informed consent\n\nExclusion Criteria:\n\n1. Patients with undiagnosed diabetic foot infection\n2. Patients who had received antibiotics within 4 weeks prior to sampling\n3. Complicated with serious systemic disease (e.g., malignant tumor, severe cardiopulmonary insufficiency, etc.)\n4. Pregnant or lactating women\n5. Cognitive impairment or inability to cooperate with the research process\n6. History of allergies or allergies to materials related to the study",{"count":128,"type":21},60,"1 Year","The objective of this study is to design and develop a gene chip for detecting pathogenic bacteria in diabetic foot infection wounds. This innovative gene chip technology enables rapid and accurate identification of pathogens at the site of infection by detecting the 16SrDNA sequence of pathogenic bacteria.\n\nDiabetic foot infection is a common serious complication in diabetic patients, often accompanied by complex pathogenic bacteria population, and due to the variety of infection types, traditional pathogen detection methods are time-consuming and low accuracy, patients may miss the best treatment opportunity. Now commonly used genetic identification of pathogenic bacteria often find a variety of bacteria, resulting in the actual pathogenic bacteria difficult to judge.",[27,132,133],"Diabetic Foot Ulcer","Diabetes","2025-01-10",{"date":136,"type":33},"2025-01-16",{"date":138,"type":21},"2025-01-31",{"date":140,"type":21},"2026-06-30",{"name":142,"class":40},"Shanghai Jiao Tong University School of Medicine",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":4},"100568719","predictors-of-diabetic-foot-outcome-in-chronic-kidney-disease-patients-100568719","NCT06684886","Predictors of Diabetic Foot Outcome in Chronic Kidney Disease Patients","Inclusion Criteria:\n\n* \\- Age ≥18 years old.\n* TYPE 2 DM with or without DF .\n* Patients are at different stages of CKD as defined according to KDIGO (9).\n\nExclusion Criteria:\n\n* \\- Patients on dialysis or CKD stage 5 (GFR \\\u003C 15 ml\u002Fmin)\n* Patients with kidney transplant\n* Pregnant patients\n* Type 1 DM",{"count":128,"type":21},"Individuals with diabetic neuropathy and Chronic kidney disease (CKD) are 15 times more likely to have a non-traumatic lower extremity amputation compared to those with DM alone . The incidence of DF and its evolution appear to be proportionally related to the stage of CKD . One of the most important causes is vascular calcification, which is common in patients with atherosclerosis, DM, CKD, and elderly .\n\nVarious factors, including age, gender, infection severity, local ischemia, diabetes duration, neuropathy, and blood sugar control, are considered potential predictors for DF outcome. However, there remains a lack of complete this study aim to Assessment of predictors of diabetic foot development and outcome in chronic kidney disease patients.",[27,152],"Chronic Kidney Disease Due to Type 2 Diabetes Mellitus",[154],"chronic kidney disease","2024-11-11",{"date":157,"type":33},"2024-11-12",{"date":159,"type":21},"2024-12-01",{"date":161,"type":21},"2026-01-30",{"name":163,"class":40},"Assiut University"]