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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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)

More Chengdu University of Traditional Chinese Medicine trials in China

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