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NCT07808502
NA

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

Sponsor: Chengdu University of Traditional Chinese Medicine

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-12

Completion Date

2028-11

Last Updated

2026-09-08

Healthy Volunteers

No

Interventions

DRUG

Modified Simiao Yongan Decoction

A 1-month course of oral granules administered following standard endovascular revascularization.

PROCEDURE

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.

Locations (1)

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China