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

NCT ID
NCT07808502
Registry status
Not yet recruiting
Study type
Not specified in the registry data
Phase
Not applicable
Sponsor
Chengdu University of Traditional Chinese Medicine

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Enrollment: 120 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages
Not specified in the registry data
Sex
Not specified in the registry data
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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.

Study locations

1 study location is listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: China

  • Sichuan, China: 1

Sample of listed locations

  • Affiliated Hospital of Chengdu University of Traditional Chinese Medicine — Chengdu, Sichuan, 610075, China — Site recruitment status not specified in the registry data

Study details

Start date
December 1, 2026
Primary completion date
June 1, 2028
First posted
September 8, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07808502
Registry last updated
September 8, 2026
QualifiedStudies registry data refreshed
September 21, 2026

View NCT07808502 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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