[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-wound\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-wound":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100580740","randomized-controlled-trial-on-the-efficacy-and-safety-of-xiang-lei-ointment-in-diabetic-related-ulcer-management-100580740",false,"NCT06841237","Randomized Controlled Trial on the Efficacy and Safety of Xiang Lei Ointment in Diabetic-related Ulcer Management","Inclusion Criteria:\n\n* a confirmed diagnosis of type 1 or type 2 diabetes mellitus that meets the standard World Health Organization definition, with blood glucose controlled prior to enrolment and a glycated haemoglobin HbA1c level of less than 10%;\n* the type of wound is an ulcer;\n* the wound etiology is diabetic, mainly abnormalities in blood glucose, resulting in poor or prolonged healing and requiring standard wound therapy;\n* the staging of the wound is in the granulation phase;\n* voluntary participation in the study and signing of an informed consent form.\n\nExclusion Criteria:\n\n* acute heart attack, heart failure, hepatitis, shock, expiratory failure and other serious diseases that have not been corrected;\n* uncontrolled blood glucose, fasting blood glucose \\> 15 mmol\u002FL and glycated haemoglobin \\> 12%;\n* active bleeding in the wound, which does not allow the implementation of the conventional basic treatment plan;\n* serum albumin \\< 20 g\u002FL; haemoglobin \\< 60 g\u002FL; platelets \\< 50 x 109\u002FL;\n* a state of disseminated infection that is being or will be treated with antibiotics\n* patients with advanced malignant tumours;\n* active autoimmune disease;\n* previous allergy to topical human granulocyte macrophage stimulating factor gel (Jinfuning);\n* inability of the patient to co-operate or mental disorder;\n* in the judgement of the investigator, the subject has a clearly irremovable cause of wound healing, is unsuitable for the study or is unable to comply with the requirements of the study.","ALL","18 Years","80 Years",{"count":19,"type":20},56,"ESTIMATED","INTERVENTIONAL",[23],"NA","Diabetes is one of the major chronic diseases. Diabetic ulcers are important adverse outcomes of diabetes. Approximately 80% of lower - limb amputations are caused by diabetic foot ulcers, which are the main causes of disability and death among patients. Moreover, it places a huge burden on the medical insurance system. Currently, there are western medicine treatment guidelines for diabetic foot, yet the clinical efficacy is less than satisfactory. The amputation rate caused by diabetic foot ulcers continues to rise every year. There is an urgent clinical need for novel and effective intervention measures to address this disease.\n\nMacrophages are important cells involved in the inflammatory and proliferative phases of wounds, playing a crucial role in wound repair and reconstruction. Diabetes can cause wounds to remain in the pro - inflammatory stage continuously, leading to the aggregation of M1 macrophages and preventing their timely transformation into the pro - proliferative and repair stage. As a result, wounds exhibit persistent chronic inflammation and delayed tissue proliferation or remodeling.\n\nXianglei Tangzu Ointment is a natural medicine approved for marketing by the National Medical Products Administration in November 2023. Its ingredients include Pogostemon cablin extract and asiaticoside. Research shows that the plant components in Xianglei Tangzu Ointment can promote the transformation of M1 macrophages into M2 macrophages, thereby reducing the inflammatory response and accelerating the proliferative repair of diabetic wounds. It has achieved certain curative effects in the clinical treatment of promoting wound healing. In order to use Xianglei Tangzu Ointment more precisely, accumulate clinical evidence - based medicine evidence, and explore the effectiveness and safety of Xianglei Tangzu Ointment in treating diabetic ulcers under the guidance of the chronic wound staging theory, clinical evidence - based medicine evidence needs to be obtained.",[26,27,28],"Diabetic Wound","Wound Infection","Wound Heal","RECRUITING","2026-02-26",{"date":32,"type":33},"2026-03-02","ACTUAL",{"date":35,"type":33},"2025-04-10",{"date":37,"type":20},"2027-02-15",{"name":39,"class":40},"Peking University Third Hospital","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100612807","mailuo-shutong-pills-for-diabetic-wound-healing-a-multicenter-randomized-trial-100612807","NCT07258381","Mailuo Shutong Pills for Diabetic Wound Healing: A Multicenter Randomized Trial","A Multicenter, Randomized Controlled Trial on the Efficacy of Mailuo Shutong Pills in Treating Diabetic Wounds With Damp-Heat Toxin Accumulation Syndrome","Inclusion Criteria:\n\n* a confirmed diagnosis of type 1 or type 2 diabetes mellitus;\n* the type of wound is an ulcer, with an ulcer area ranging from 1 to 40cm ²;\n* the wound etiology is diabetic, mainly abnormalities in blood glucose, resulting in poor or prolonged healing and requiring standard wound therapy;\n* The traditional Chinese medicine diagnosis is Damp-Heat Toxin Accumulation Syndrome;\n* voluntary participation in the study and signing of an informed consent form.\n\nExclusion Criteria:\n\n* Diagnosis of a Cold Pattern according to Traditional Chinese Medicine (TCM) differentiation, manifested as: pale, enlarged, and tender tongue with a white, moist or glossy coating; pallor; pale lips; aversion to cold with a preference for warmth; and loose stools.\n* Pregnancy or lactation.\n* Presence of severe, uncorrected systemic diseases, such as acute myocardial infarction, heart failure, hepatitis, shock, or respiratory failure.\n\nActive bleeding within the wound that prevents the implementation of standard wound care.\n\n* Severe laboratory abnormalities: serum albumin \\\u003C 20 g\u002FL; hemoglobin \\\u003C 60 g\u002FL; or platelet count \\\u003C 50 × 10⁹\u002FL.\n* Diagnosis of advanced malignant tumor.\n* Active phase of an autoimmune disease.\n* History of hypersensitivity to Mailuo Shutong Pills or Mailuo Shutong Granules.\n* Inability to cooperate with the study procedures or presence of psychiatric disorders.\n* Any other condition considered by the investigator as a clear, unmodifiable factor adversely affecting wound healing, making the candidate unsuitable for the study or unable to comply with the study requirements.",{"count":19,"type":20},[23],"Mailuo Shutong Pills are a Chinese patent medicine approved for market release by the China Food and Drug Administration (CFDA) in 2009. It is formulated by integrating five classical herbal formulas, including Ermiao San, Simiao Yongan Tang, and Zhijing San. Its composition is as follows: Honeysuckle Flower (Jinyinhua) serves as the principal component (Jun herb) for clearing heat and detoxifying; Astragalus Root (Huangqi) for tonifying qi, expelling toxin, and promoting diuresis; Phellodendron Bark (Huangbai), Atractylodes Rhizome (Cangzhu), and Coix Seed (Yiyiren) act as deputy components (Chen herbs) to clear heat and resolve dampness; Chinese Angelica (Danggui), Peony Root (Baishao), and Licorice Root (Gancao) alleviate spasm and pain; Figwort Root (Xuanshen) cools the blood, clears heat, drains fire, detoxifies, and softens hard masses. Leeches (Shuizhi), Centipede (Wugong), and Scorpion (Quanxie) serve as assistant components (Zuo herbs) to invigorate blood, resolve stasis, attack toxicity, dissipate nodules, and unblock collaterals to relieve pain. Licorice Root (Gancao) also harmonizes the various components in the formula as the envoy component (Shi herb). The complete formula possesses the effects of clearing heat and detoxifying, dissolving stasis and unblocking collaterals, and dispelling dampness and reducing swelling. It is indicated for various conditions differentiated in Traditional Chinese Medicine (TCM) as presenting with a pattern of dampness-heat and stasis obstruction, such as superficial thrombophlebitis and deep vein thrombosis in the non-acute stage.\n\nSome studies suggest that Mailuo Shutong Pills may have a positive effect in the field of wound healing, for example, by significantly reducing the release of inflammatory mediators such as IL-1β, IL-6, CRP, and TNF-α caused by inflammatory diseases \\[11-13\\], and accelerating the healing of diabetic foot wounds \\[14\\]. Clinical guidelines, including the \"Clinical Application Guide for Chinese Patent Medicines - Diabetes Volume\" from the Diabetes Branch of the China Association of Chinese Medicine and the \"Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment Guidelines for Diabetic Foot\" from the Chinese Medical Doctor Association, recommend Mailuo Shutong Pills for the treatment of diabetic foot ulcers \\[15\\]. However, the current related evidence-based medical evidence is insufficient. We have also observed that the adjunctive use of Mailuo Shutong Pills does not guarantee a shortened healing time for all patients with diabetic wounds. From a TCM perspective, the presence of a dampness-heat and stasis obstruction pattern is a key factor determining the efficacy of adjunctive Mailuo Shutong therapy. For Western medicine practitioners, tongue diagnosis presents a practicable factor for assessing pattern manifestation. Therefore, based on differences in patient patterns and using tongue appearance as an inclusion\u002Fexclusion criterion, to screen for the indications of Mailuo Shutong Pills combined with existing standard treatment for diabetic wounds constitutes an effective technical approach to address the aforementioned issues.\n\nConsequently, this study aims to explore the indications for Mailuo Shutong Pills in diabetic wounds and obtain evidence-based medical evidence for its clinical efficacy within an integrated Chinese-Western medicine approach. Furthermore, to enhance the study's external validity and participant recruitment efficiency, thereby accelerating the research progress, this study is designed as an exploratory trial conducted across multiple centers.",[26,53],"Chronic Wound Care",[55,56],"diabetic wound","chronic wound care","NOT_YET_RECRUITING","2025-11-30",{"date":60,"type":33},"2025-12-02",{"date":62,"type":20},"2025-12-01",{"date":64,"type":20},"2027-12-01",{"name":39,"class":40}]