Clinical Efficacy of Modified Simiao Yongan Decoction and Endovascular Therapy for Diabetic Foot Ulcers

Clinical Efficacy and Mechanism of Modified Simiao Yongan Decoction Combined With Endovascular Therapy for Diabetic Foot Ulcers (Damp-Heat Toxins Accumulation Syndrome) Based on the Vascular-Immune Microenvironment

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.

This is a single-center, prospective, non-randomized, parallel-controlled cohort study designed to address the clinical challenge of delayed diabetic foot ulcer (DFU) healing despite upstream vascular recanalization. The study will enroll 120 patients, assigned to either a standard treatment control group or an experimental group. The control group will receive standard endovascular intervention, an anti-thrombotic regimen, and standard wound care. The experimental group will receive these same standard treatments plus a one-month regimen of Modified Simiao Yongan Decoction.

The study's primary endpoints evaluate Major Adverse Limb Events (MALE) and Major Adverse Cardiovascular Events (MACE). Secondary clinical outcomes include the complete ulcer healing time, clinical-driven target lesion revascularization (CD-TLR), ankle-brachial index (ABI), transcutaneous oxygen pressure (TcPO2), and changes in Traditional Chinese Medicine syndrome scores and VascuQoL-6 scores.

In addition to clinical metrics, the research investigates the underlying molecular mechanisms, specifically how the intervention regulates the vascular-immune microenvironment through the HIF-1α/VEGF pathway and macrophage polarization to promote angiogenesis and tissue repair. Statistical analyses will employ Inverse Probability of Treatment Weighting (IPTW) to balance baseline characteristics and the Fine-Gray competing risk model for robust outcome evaluation.

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.