Modified Simiao Yongan DecoctionEndovascular Therapy and Standard Care
Modified Simiao Yongan Decoction: A 1-month course of oral granules administered following standard endovascular revascularization.
Endovascular Therapy and Standard Care: Standard revascularization via endovascular intervention, supplemented with a standardized post-operative antithrombotic regimen. Standard care also includes strict blood glucose control, infection management, wound decompression, regular dressing changes, and necessary nutritional support.
Study summary
This study evaluates the clinical efficacy and safety of a Modified Simiao Yongan Decoction when used alongside standard endovascular therapy and wound care for the treatment of diabetic foot ulcers. The trial focuses on patients presenting with the damp-heat toxins accumulation syndrome (Rutherford 4-5 or Wagner 2-4 classifications). Enrolling 120 participants, the study aims to observe the complete ulcer healing rate, limb salvage outcomes, and improvements in patient quality of life over a 6 to 24-month follow-up period.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Diagnosed with a Diabetic Foot Ulcer (DFU).
* Assessed as Rutherford classification 4-5 or Wagner classification 2-4.
* Successfully received lower extremity endovascular intervention.
* Meets the Traditional Chinese Medicine diagnostic criteria for "Damp-Heat Toxins Accumulation Syndrome". Patients must exhibit at least two primary symptoms (red/swollen/hot/painful limb, high exudate or purulent secretion with foul odor, dark purple wound/necrotic tissue, elevated local skin temperature) and at least one secondary symptom (dry mouth/bitter taste, dry stool, red tongue with yellow greasy coating, rapid/string-taut pulse).
Exclusion Criteria:
* Patients with severe, uncontrolled life-threatening systemic diseases, such as severe heart failure (NYHA class III-IV), severe hepatic or renal dysfunction, or active malignancy.
* Patients with active systemic sepsis, extensive gangrene, or severe osteomyelitis requiring immediate major amputation of the target limb.
* Patients with known allergies, hypersensitivity, or severe adverse reactions to any of the herbal components of the Modified Simiao Yongan Decoction.
* Patients with severe gastrointestinal disorders that would significantly impair the absorption of oral medications.
* Women who are pregnant, planning to become pregnant, or currently lactating.
* Patients with severe cognitive impairment, psychiatric disorders, or poor compliance that would prevent them from providing informed consent or adhering to the 24-month follow-up schedule.
* Patients currently participating in, or who have participated in within the last 30 days, another interventional clinical trial.
Primary outcome measure(s)
Incidence of Major Adverse Limb Events (MALE) — Up to 24 months post-operatively A composite endpoint defined as major amputation of vascular etiology or clinical-driven target lesion revascularization (CD-TLR)
Incidence of Major Adverse Cardiovascular Events (MACE) and Major Bleeding. — Up to 24 months post-operatively A composite endpoint defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke, alongside any major bleeding events requiring medical intervention.
Trial sites (1)
Facility
City
Region
Status
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu
Sichuan
More Chengdu University of Traditional Chinese Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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