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| Name | Class |
|---|---|
| Affiliated Hospital of Shandong University of Traditional Chinese Medicine | OTHER |
| Dongzhimen Hospital, Beijing | OTHER |
| Peking University Third Hospital | OTHER |
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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:
Does 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?
Is the treatment combination safe for participants?
Researchers will compare two groups:
Group 1 (Experimental): Standard treatment (including aspirin, and medicines for blood sugar and cholesterol control) plus Hua Yu Wan Capsule.
Group 2 (Control): Standard treatment alone.
Participants in this study will:
Be 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).
Be randomly assigned to one of the two treatment groups.
Take their assigned treatment for 6 months.
Attend 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Therapy and Hua Yu Wan Capsule | Experimental | 1． Standard Baseline Medication: Hua Yu Wan Capsule: 5g, taken orally two times daily. Treatment Duration: The combined regimen is administered continuously for 6 months (divided into four 6-week cycles). 2. Follow-up: After the 6-month treatment period, participants enter a 12-month follow-up phase for observational assessments without receiving the study drug. |
|
| Standard Therapy Alone | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hua Yu Wan Capsule | Drug | A modern preparation of the classic Traditional Chinese Medicine formula Bu Yang Huanwu Decoction. Each capsule contains 0.2g of the herbal extract. Dosage and Route: 2 capsules, taken orally three times daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of new-onset ischemic rest pain or foot ulcer at 12 months of treatment. | Ischemic Rest Pain: Persistent pain in the toes/forefoot at rest, typically nocturnal, worsened by elevation, relieved by dependency, often with pallor/coldness. Foot Ulcer: Ischemic skin breakdown/tissue necrosis in pressure areas (toes, heel, sole), with well-defined edges, dry/necrotic base, poor perfusion, and absence of significant inflammation. Assessment Method: Clinical evaluation by investigator at each scheduled visit. Confirmed by physical examination and documented photographically if applicable. | From enrollment to the end of treatment at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with investigator-confirmed new-onset ischemic rest pain or clinically confirmed ischemic foot ulcer at 12 months | Composite primary outcome defined as the number of participants who develop either: (1) new-onset ischemic rest pain confirmed by investigator clinical assessment, or (2) ischemic foot ulcer confirmed by physical examination with photographic documentation when applicable, by Month 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with clinically significant bleeding events | Number of participants with bleeding events during the study. Unit of Measure: Participants | Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18 |
| Number of participants with clinically significant abnormal physical examination findings |
Inclusion Criteria:
Aged 18 to 70 years (inclusive), male or female.
Diagnosed with diabetes mellitus according to the Chinese Diabetes Society (2024) Guidelines.
Glycated hemoglobin (HbA1c) < 12%, with recent fasting blood glucose < 7.0 mmol/L OR postprandial blood glucose < 10.0 mmol/L, and triglycerides < 1.7 mmol/L.
Diagnosed with LEAD, meeting the following criteria:
Rutherford Classification 2, 3, or 4.
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%.
Evidence of lower limb arterial stenosis or occlusion confirmed by duplex ultrasound, CTA, MRA, or DSA.
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"):
Main Symptom: Lower limb weakness, or feeling of heaviness/discomfort after prolonged walking.
Secondary Symptoms: Shortness of breath/lassitude in speaking; dry mouth with desire to drink; scaly skin.
Tongue & Pulse: Tongue with teeth marks, pale-purple with petechiae/ecchymosis; thin and choppy pulse.
(Diagnosis confirmed by meeting 1 main symptom OR 2 secondary symptoms, assessed by a qualified TCM practitioner.)
Voluntarily signs the Informed Consent Form (ICF) and is willing and able to comply with all study procedures and visits.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JIANMING GUO, M.D. | Contact | +86 13146369562 | guojianming@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital | Beijing | China |
|
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D003925 | Diabetic Angiopathies |
| D001157 | Arterial Occlusive Diseases |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Aspirin | Drug | Aspirin: 100 mg, administered orally once daily. Treatment Duration: The standard medication is administered continuously for 12 months. |
|
| From enrollment to the end of treatment at 12 months |
| Number of participants with major adverse cardiovascular and cerebrovascular events (MACCE) | MACCE is defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. | From enrollment to the end of treatment at 12 months |
| Number of participants hospitalized during the study | Number of participants who require inpatient hospitalization for any cause during the study period, as confirmed by hospital admission records or investigator documentation. Repeated hospitalizations in the same participant will be counted once unless otherwise specified in the statistical analysis plan. | From enrollment to the end of treatment at 12 months |
| Number of participants who die during the study | Number of participants who die from any cause during the study period, as confirmed by medical records, death certificates, hospital documentation, or investigator follow-up. Each participant will be counted once. | From enrollment to the end of treatment at 12 months |
| Change in ankle-brachial index（ABI） from baseline | Change in ankle-brachial index from baseline: Month 1, Month 3, and Month 6 during the treatment period; Month 6 and Month 12 during the follow-up period. | reported at Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18 |
| Change in toe-brachial index (TBI) from baseline | Change in toe-brachial index from baseline: Month 1, Month 3, and Month 6 during the treatment period; Month 6 and Month 12 during the follow-up period. | reported at Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18 |
| Change in intermittent claudication distance from baseline | Change in intermittent claudication distance from baseline: Month 1, Month 3, and Month 6 during the treatment period; Month 6 and Month 12 during the follow-up period. | Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18 |
| Rate of clinically driven lower-extremity arterial revascularization after treatment | Rate of clinically driven lower-extremity arterial revascularization after treatment, including endovascular or open surgical revascularization: Month 1, Month 3, and Month 6 during the treatment period; Month 6 and Month 12 during the follow-up period. | From enrollment to the end of treatment at 12 months |
| Change in Vascular Quality of Life Questionnaire-6 score from baseline | Change in Vascular Quality of Life Questionnaire-6 score from baseline: Month 1, Month 3, and Month 6 during the treatment period; Month 6 and Month 12 during the follow-up period. | From enrollment to the end of treatment at 12 months |
| Change in Traditional Chinese Medicine syndrome score from baseline | Change in Traditional Chinese Medicine syndrome score from baseline: Month 1, Month 3, and Month 6 during the treatment period; Month 6 and Month 12 during the follow-up period. | From enrollment to the end of treatment at 12 months |
Number of participants with clinically significant abnormal findings on physical examination. |
| Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18 |
| Number of participants with clinically significant abnormal hematology test results | Number of participants with clinically significant abnormalities in hematology parameters, including white blood cell count, red blood cell count, hemoglobin, and platelet count. | Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18 |
| Number of participants with clinically significant abnormal urinalysis results | Number of participants with clinically significant abnormalities in urinalysis parameters, including urine white blood cells, urine red blood cells, urine glucose, and urine protein. | Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18 |
| Number of participants with clinically significant abnormal liver function test results | Number of participants with clinically significant abnormalities in liver function parameters, including alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, and gamma-glutamyl transferase. | Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18 |
| Number of participants with clinically significant abnormal renal function test results | Number of participants with clinically significant abnormalities in renal function parameters, including blood urea nitrogen or urea, and serum creatinine. | Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18 |
| Number of participants with clinically significant abnormal coagulation test results | Number of participants with clinically significant abnormalities in coagulation function parameters, including thrombin time, prothrombin time, activated partial thromboplastin time, international normalized ratio, and fibrinogen. | Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18 |
| Change in Body Temperature From Baseline | Change in body temperature from baseline at each scheduled assessment. Unit of Measure: Degrees Celsius | Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18 |
| Change in Pulse Rate From Baseline | Change in pulse rate from baseline at each scheduled assessment. Unit of Measure: Beats per minute | Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18 |
| Change in Respiratory Rate From Baseline | Change in respiratory rate from baseline at each scheduled assessment. Unit of Measure: Breaths per minute | Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18 |
| Change in Systolic Blood Pressure From Baseline | Change in systolic blood pressure from baseline at each scheduled assessment. Unit of Measure: mmHg | Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18 |
| Change in Diastolic Blood Pressure From Baseline | Change in diastolic blood pressure from baseline at each scheduled assessment. Unit of Measure: mmHg | Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18 |
| Number of participants with clinically significant abnormal 12-lead electrocardiogram findings | Measure Description: Number of participants with clinically significant abnormal findings on 12-lead electrocardiogram, as assessed by the investigator. Unit of Measure: Participants | Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18 |
| Number of participants with positive pregnancy test results | Number of female participants of childbearing potential with positive pregnancy test results during the study. | Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18 |
| Number of Participants With Allergic Reactions | Number of participants with allergic reactions during the study. | Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18 |
| Number of Participants With Gastrointestinal Adverse Reactions | Number of participants with gastrointestinal adverse reactions during the study. | Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18 |
| Number of Participants With Nervous System Adverse Reactions | Number of participants with nervous system adverse reactions during the study. | Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18 |
| D016491 |
| Peripheral Vascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |