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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