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.
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).
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.
Parallel
Modified Simiao Yongan Decoction
DrugA 1-month course of oral granules administered following standard endovascular revascularization.
Endovascular Therapy and Standard Care
Procedure/SurgeryStandard 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.
Incidence of Major Adverse Limb Events (MALE)
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.
A composite endpoint defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke, alongside any major bleeding events requiring medical intervention.
Complete Ulcer Healing Rate and Time
The rate and total time required for the target diabetic foot ulcer to completely heal.
Ankle-Brachial Index (ABI)
The ankle-brachial index (ABI) of the target limb will be measured to assess lower-extremity macrovascular perfusion. ABI is calculated as the ratio of ankle systolic blood pressure to brachial systolic blood pressure.
Transcutaneous Oxygen Pressure (TcPO2)
Transcutaneous oxygen pressure (TcPO2) of the target limb will be measured in mmHg to assess local tissue oxygenation and microcirculatory perfusion.
Traditional Chinese Medicine Damp-Heat Toxins Accumulation Syndrome Score
The Traditional Chinese Medicine Damp-Heat Toxin Accumulation Syndrome Score is used to assess the severity of syndrome-related symptoms and signs. The scale consists of eight items, including four primary symptoms and four secondary symptoms. Each item is scored from 0 to 3, where 0 indicates absence of the symptom and 3 indicates severe manifestations. The total score ranges from 0 to 24, with higher scores indicating greater syndrome severity and therefore a worse outcome.
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