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| ID | Type | Description | Link |
|---|---|---|---|
| 2024ZD0532600, 2024ZD0532603 | Other Grant/Funding Number | National Health Commission Science & Technology Development Research Center |
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| Name | Class |
|---|---|
| Beijing Shijitan Hospital, Capital Medical University | OTHER |
| Peking University Third Hospital | OTHER |
| Dongzhimen Hospital, Beijing | OTHER |
| Xuanwu Hospital, Beijing |
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Taking the approach of promoting qi circulation and activating blood as the entry point, this study targets lower extremity arterial disease(LEAD) patients with TCM syndrome pattern of blood stasis due to qi stagnation. Using Guanxinning Tablets (a herbal formula with qi-moving and blood-activating properties) as the investigational medication, we will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of the classic herb pair (Chuanxiong Rhizoma-Salviae Miltiorrhizae) in preventing LEAD ulcer recurrence. This research aims to accumulate evidence-based medical data supporting new drug development.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | Background Therapy Strict dietary control Standardized medication Administered according to glycemic, lipid, and blood pressure treatment guidelines Individualized antithrombotic regimen:
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| Placebo Arm | Placebo Comparator | ackground Therapy Strict dietary control Standardized medication Administered according to glycemic, lipid, and blood pressure treatment guidelines Individualized antithrombotic regimen:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guanxinning Tablets | Drug | Guanxinning Tablets
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| Measure | Description | Time Frame |
|---|---|---|
| Ulcer Recurrence Rate | Ulcer Recurrence Rate = (Number of Subjects with Recurrent Ulcers / Total Subjects) × 100% | Measured at 6 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Ulcer Recurrence Rate | Ulcer Recurrence Rate = (Number of Subjects with Recurrent Ulcers / Total Subjects) × 100% | Ulcer recurrence rates at 3, 9, and 12 months post-intervention |
| Calculation of ulcer recurrence episodes |
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Inclusion Criteria:
Age: 18 to 80 years old (inclusive)
Diagnosis: Confirmed type 1 or type 2 diabetes mellitus
Meeting diagnostic criteria for diabetic lower extremity arterial disease (DLEAD)
TCM Syndrome: Qualified for Qi Stagnation and Blood Stasis syndrome pattern
Glycemic Control:
Ulcer History:
Consent: Voluntarily signed informed consent form
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yannan Wang | Contact | +86 13791130209 | cweiyue@163.com |
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| OTHER |
| The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine | OTHER |
| Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology | OTHER |
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| Matching Placebo for Guanxinning | Drug | Matching Placebo for Guanxinning Tablets
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Recurrence is counted based on the timing of occurrence. Ulcers appearing concurrently at distinct anatomical sites are counted as one episode; those occurring at different time points are counted as multiple episodes.
| Assessed at 6 months post-intervention |
| Ankle-Brachial Index | 6 and 12 months after intervention |
| TCM Syndrome Score | TCM Syndrome Scoring Scale Description This scale quantifies six core manifestations of Qi Stagnation and Blood Stasis Syndrome in diabetic lower extremity arterial disease, using a four-tier scoring system (0/2/4/6 points): Limb coldness: Asymptomatic (0 pts); Occasional, self-relieved (2 pts); Persistent, relieved by warmth (4 pts); Persistent, unrelieved by warmth (6 pts) Limb pain: None (0 pts); Mild (2 pts); Moderate (4 pts); Severe (sleep-disturbing) (6 pts) Chest/abdominal distension: Absent (0 pts); Occasional mild (2 pts); Frequent moderate (4 pts); Frequent severe (6 pts) Skin temperature: Normal (0 pts); Slightly decreased (2 pts); Significantly decreased (4 pts); Cold (6 pts) Intermittent claudication: Absent (0 pts); Distance >500 meters (2 pts); 200-500 meters (4 pts); ≤200 meters (6 pts) Foot coloration: Normal (0 pts); Dark red (2 pts); Pale/purplish-dark (4 pts); Cyanosis/ecchymosis (6 pts) | at 3 and 6 months post-intervention |
| Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)、All-Cause Mortality | 3, 6, 9, and 12 months after intervention |