[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-angiopathies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-angiopathies":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100641226","phase-3-evaluating-bu-yang-huanwu-decoction-for-early-diabetic-vascular-disease-100641226",false,"NCT07658807","Evaluating Bu Yang Huanwu Decoction For Early Diabetic Vascular Disease","Evidence-Based Evaluation and New Drug Translation Research of Early Intervention With the Classic Traditional Chinese Medicine Formula Bu Yang Huanwu Decoction for Preventing and Treating Diabetic Lower Extremity Vascular Disease","Inclusion Criteria:\n\n1. Aged 18 to 70 years (inclusive), male or female.\n2. Diagnosed with diabetes mellitus according to the Chinese Diabetes Society (2024) Guidelines.\n3. Glycated hemoglobin (HbA1c) \\\u003C 12%, with recent fasting blood glucose \\\u003C 7.0 mmol\u002FL OR postprandial blood glucose \\\u003C 10.0 mmol\u002FL, and triglycerides \\\u003C 1.7 mmol\u002FL.\n4. Diagnosed with LEAD, meeting the following criteria:\n\n   Rutherford Classification 2, 3, or 4.\n\n   Resting ABI ≤ 0.90, OR for patients with exertional symptoms and resting ABI \\> 0.90, a post-exercise treadmill test showing an ABI decrease of ≥15%.\n\n   Evidence of lower limb arterial stenosis or occlusion confirmed by duplex ultrasound, CTA, MRA, or DSA.\n5. TCM Pattern Diagnosis: Must conform to the TCM syndrome of Qi Deficiency and Blood Stasis, as defined by the study's TCM diagnostic criteria (referencing \"Practical Diagnostic Criteria for Blood Stasis Syndrome\" and \"Integrated Chinese and Western Medicine Peripheral Vascular Disease\"):\n\n   Main Symptom: Lower limb weakness, or feeling of heaviness\u002Fdiscomfort after prolonged walking.\n\n   Secondary Symptoms: Shortness of breath\u002Flassitude in speaking; dry mouth with desire to drink; scaly skin.\n\n   Tongue \\& Pulse: Tongue with teeth marks, pale-purple with petechiae\u002Fecchymosis; thin and choppy pulse.\n\n   (Diagnosis confirmed by meeting 1 main symptom OR 2 secondary symptoms, assessed by a qualified TCM practitioner.)\n6. Voluntarily signs the Informed Consent Form (ICF) and is willing and able to comply with all study procedures and visits.\n\nExclusion Criteria:\n\n1. Known bleeding disorders or history of intracranial hemorrhage.\n2. Current use of anticoagulants (e.g., warfarin, dabigatran, factor Xa inhibitors).\n3. Presence of active infection.\n4. Severe cardiac abnormalities on resting ECG (e.g., heart failure, ventricular tachycardia, ventricular fibrillation, multifocal ventricular contractions, prolonged corrected QT interval).\n5. History of acute coronary syndrome ≤ 12 months requiring dual antiplatelet therapy.\n6. Chronic liver disease (Child-Turcote-Pugh score ≥5) or chronic kidney disease stages 4-5 (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²).\n7. History of malignancy (except cured basal cell carcinoma).\n8. Moderate to severe anemia, polycythemia vera, or any hyperviscosity syndrome.\n9. Planned lower limb revascularization or amputation.\n10. Concurrent or planned use of medicinal products containing Veratrum species.\n11. Pregnant or lactating women, or women of childbearing potential not using highly effective contraception.\n12. Known allergy or hypersensitivity to any component of the study medication (Qilong Capsules, aspirin).\n13. Patients with psychiatric disorders or judged to be uncooperative.\n14. Currently participating in another drug clinical trial or using therapies with similar purported effects.\n15. Any other condition deemed by the investigator to make the participant unsuitable for the trial.","ALL","18 Years","70 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The goal of this clinical trial is to learn if adding a Traditional Chinese Medicine formula, Bu Yang Huanwu Decoction (specifically the capsule form called Hua Yu Wan Capsule), to standard treatment can help prevent leg pain at rest or foot ulcers in people with diabetic lower extremity vascular disease. The main questions it aims to answer are:\n\nDoes adding Hua Yu Wan Capsule to standard treatment lower the chance of developing leg pain at rest or foot ulcers after one year, compared to standard treatment alone?\n\nIs the treatment combination safe for participants?\n\nResearchers will compare two groups:\n\nGroup 1 (Experimental): Standard treatment (including aspirin, and medicines for blood sugar and cholesterol control) plus Hua Yu Wan Capsule.\n\nGroup 2 (Control): Standard treatment alone.\n\nParticipants in this study will:\n\nBe adults aged 18 to 70 years with diabetes and early to moderate lower extremity vascular disease (confirmed by tests like the Ankle-Brachial Index or ABI).\n\nBe randomly assigned to one of the two treatment groups.\n\nTake their assigned treatment for 6 months.\n\nAttend clinic visits at 1, 3 and 6 months during treatment, and again at 6 and 12 months after treatment ends for check-ups and tests.",[27,28,29],"Peripheral Arterial Disease","Diabetic Angiopathies","Arterial Occlusive Diseases",[27,31,32,33],"Ischemia","Medicine, Chinese Traditional","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-06-15",{"date":37,"type":38},"2026-06-22","ACTUAL",{"date":40,"type":21},"2026-06",{"date":42,"type":21},"2029-01",{"name":44,"class":45},"Xuanwu Hospital, Beijing","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":79,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":92,"locationsCount":46},"100567960","clinical-trial-assessing-human-placental-membrane-products-and-standard-of-care-versus-standard-of-care-in-nonhealing-dfus-and-vlus-100567960","NCT06674980","Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs","A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.","C5CAMP","Inclusion Criteria for DFU:\n\n1. At least 18 years of age or older.\n2. Must have diagnosis of type 1 or 2 Diabetes mellitus.\n3. At enrollment, subject must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with the imaging device.\n4. Must have a target ulcer that has been present for a minimum of 4 weeks and maximum of 52 weeks of standard of care, prior to screening visit.\n5. Target ulcer located on the foot with at least 50% of the ulcer below the malleolus.\n6. Target ulcer that is Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.\n7. Subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n   1. ABI between 0.7 and \\\u003C= 1.3\n   2. TBI \\>= 0.6\n   3. TCOM \\>= 40 mmHg\n   4. PVR: biphasic\n8. If subject has two or more ulcers, they must be separated by 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n9. Target ulcer must be located on the plantar aspect of the foot and must be offloaded for at least 14 days prior to enrollment.\n10. Subject must consent to using the prescribed offloading method for the duration of the study.\n11. Subject must agree to attend weekly study visits.\n12. Subject must be willing and able to participate in the consent process.\n\nExclusion Criteria for DFU:\n\n1. Subject is known to have a life expectancy of \\\u003C 6 months.\n2. Subject's target ulcer is not secondary to diabetes.\n3. Target ulcer is infected or there is cellulitis in the surrounding skin.\n4. Target ulcer exposes tendon or bone.\n5. Evidence of osteomyelitis complicating the target ulcer.\n6. Infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.\n7. The subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n8. Subject is taking hydroxyurea.\n9. Subject has applied topical steroids to the ulcer surface within one month of initial screening.\n10. Subject has a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.\n11. Subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n12. The surface area of the subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n13. The surface area measurement of the subject's target ulcer decreases by 20% or more during the active 2-week screening phase.\n14. Subject has acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.\n15. Subject is a woman who is pregnant or considering becoming pregnant in the next 6 months.\n16. Subject has end stage renal disease requiring dialysis.\n17. Subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.\n18. The subject, in opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments.\n19. Subject was treated with hyperbaric oxygen therapy or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to screening.\n20. Subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n\nInclusion Criteria for VLU:\n\nPotential subjects are required to meet all the following criteria for enrollment in the study.\n\n1. Subjects must be at least 18 years of age or older.\n2. At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20 cm2 measured post-debridement.\n3. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.\n4. No visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.\n5. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n   1. ABI between 0.7 and ≤ 1.3;\n   2. TBI ≥ 0.6;\n   3. TCOM ≥ 40 mmHg;\n   4. PVR: biphasic.\n6. If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n7. The potential subject must agree to attend the weekly study visits required by the protocol.\n8. The potential subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria for VLU:\n\n1. The potential subject is known to have a life expectancy of \\\u003C 6 months.\n2. The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.\n3. The target ulcer exposes tendon or bone.\n4. There is evidence of osteomyelitis complicating the target ulcer.\n5. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n6. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n7. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n8. The surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n9. The surface area measurement of the target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.\n10. Women who are pregnant or considering becoming pregnant within the next 6 months.\n11. The potential subject has end stage renal disease requiring dialysis.\n12. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.\n13. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n14. The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.\n15. The subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n16. A subject has a wound with active or latent infection is excluded.\n17. A subject with a disorder that would create unacceptable risk of post-operative complications is excluded.",{"count":56,"type":21},177,[58],"NA","The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) over 12 weeks using a modified platform trial design.",[61,62,63,64,65,28,66,67,68,69,70,71,72,73,74,75,76,77,78],"Pathologic Processes","Diabetes Mellitus","Glucose Metabolism Disorders","Metabolic Diseases","Endocrine System Disease","Vascular Diseases","Cardiovascular Diseases","Leg Ulcer","Skin Ulcer","Skin Diseases","Diabetes Complications","Diabetic Neuropathies","Foot Diseases","Diabetic Foot","Foot Ulcer","Diabetes Mellitus, Type 2","Ulcer","Foot Ulcer Unhealed",[80,81,82,83,84],"Human Placental Membrane (HPM)","Diabetic Foot Ulcer (DFU)","Venous Leg Ulcer (VLU)","Cellular, Acellular, and Matrix-like Product (CAMP)","Cellular and\u002For Tissue-Based Product (CTP)","RECRUITING","2024-12-20",{"date":88,"type":38},"2024-12-27",{"date":86,"type":38},{"date":91,"type":21},"2027-01-22",{"name":93,"class":94},"C5 Biomedical","INDUSTRY"]