Diabetic Lower Extremity Arterial Disease
Conditions
Keywords
Recurrence of ulcer, Diabetic Lower extremity arterial disease, Interventional Study, Prevention, Guanxinning Tablets, Salviae Miltiorrhizae, Chuanxiong Rhizoma
Brief summary
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.
Interventions
DRUGGuanxinning Tablets
Guanxinning Tablets * Manufacturer: Zhengda Qingchunbao Pharmaceutical Co., Ltd. * NMPA Approval No. Z20150028 * Administration: 4 tablets orally, three times daily for 6 months
DRUGMatching Placebo for Guanxinning
Matching Placebo for Guanxinning Tablets * Manufacturer: Zhengda Qingchunbao Pharmaceutical Co., Ltd. * Drug Product Certificate of Analysis Approval No.YF-R-C037A-2024104-A * Administration: 4 tablets orally, three times daily for 6 months
Sponsors
Beijing Shijitan Hospital, Capital Medical University
Peking University Third Hospital
Dongzhimen Hospital, Beijing
Xuanwu Hospital, Beijing
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Zheng Liu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18 to 80 years old (inclusive) 2. Diagnosis: Confirmed type 1 or type 2 diabetes mellitus 3. Meeting diagnostic criteria for diabetic lower extremity arterial disease (DLEAD) 4. TCM Syndrome: Qualified for Qi Stagnation and Blood Stasis syndrome pattern 5. Glycemic Control: * HbA1c ≤9% or Fasting plasma glucose ≤10 mmol/L 6. Ulcer History: * Documented history of diabetic lower extremity arterial disease (DLEAD)-related ulcers, with confirmed healing (wound re-epithelialization without signs of redness, purulent discharge, or infection) 2-8 weeks prior to enrollment. 7. Consent: Voluntarily signed informed consent form
Exclusion criteria
* (1) Ulcer Etiology Exclusion: * Pure pressure ulcers * Pure neuropathic ulcers * Immune-mediated ulcers (e.g., vasculitic ulcers caused by lupus, Behcet's disease, rheumatoid arthritis) (2) Recent Cardiovascular Events: * Acute coronary syndrome within 3 months * Hemorrhagic stroke within 3 months (3) Organ Dysfunction: * Severe hepatic impairment (AST or ALT \>1.5×ULN) * Chronic kidney disease stage 4-5 (eGFR \<30 mL/min/1.73m²) (4) Recent Major Bleeding: * Gastrointestinal hemorrhage within 1 month (5) Concurrent TCM Therapy: * Use of blood-activating/stasis-resolving TCM preparations for DLEAD within 1 week (6) Herbal Contraindication: * Concurrent or planned use of \*Veratrum\*-containing preparations (7) Malignancy: * Active cancer progression (8) Reproductive Status: * Pregnant or lactating women (9) Allergy History: * Known hypersensitivity to \*Ligusticum chuanxiong\* or \*Salvia miltiorrhiza\* (10) Cognitive/Language Barriers: * Psychiatric disorders * Intellectual/language impairment affecting scale completion * Unwillingness to cooperate (11) Life Expectancy: * \<1 year (12) Clinical Trial Participation: * Enrollment in other drug trials within 1 month (13) Investigator's Discretion: * Other conditions deemed unsuitable for participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer Recurrence Rate | Measured at 6 months post-intervention | Ulcer Recurrence Rate = (Number of Subjects with Recurrent Ulcers / Total Subjects) × 100% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer Recurrence Rate | Ulcer recurrence rates at 3, 9, and 12 months post-intervention | Ulcer Recurrence Rate = (Number of Subjects with Recurrent Ulcers / Total Subjects) × 100% |
| Calculation of ulcer recurrence episodes | Assessed at 6 months post-intervention | 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. |
| Ankle-Brachial Index | 6 and 12 months after intervention | — |
| TCM Syndrome Score | at 3 and 6 months post-intervention | 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) |
| Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)、All-Cause Mortality | 3, 6, 9, and 12 months after intervention | — |
Contacts
Primary ContactYannan Wang
Outcome results
None listed