Electroacupuncture at Zusanli (ST-36) to help heal diabetic foot ulcers
Clinical Observation and Mechanism Study on the Therapeutic Effect of Electroacupuncture at Zusanli (ST-36) in Promoting Diabetic Foot Wound Healing Through Mediating Macrophage Polarization
This will see if adding electroacupuncture at the Zusanli (ST-36) point to standard wound and diabetes care helps heal diabetic foot ulcers in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Zhongda Hospital Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT07482137 on ClinicalTrials.gov |
What this trial studies
Adults with diabetic foot ulcers (Wagner grade 1–3, ulcer area 2–30 cm²) will be assigned to receive standard diabetes and wound care with or without additional electroacupuncture at the Zusanli (ST‑36) point. Standard care includes diabetes education, glucose control with insulin and/or oral agents, antibiotics if needed, regular wound cleaning and daily dressing changes, and drainage of abscesses when present. The electroacupuncture group will receive electrical stimulation at ST‑36 in addition to this care, and researchers will compare wound-healing outcomes between the groups over the study period. Eligible patients must also meet Traditional Chinese Medicine criteria for blood stasis obstructing the collateral pattern and have HbA1c below 9%.
Who should consider this trial
Good fit: Ideal candidates are adults 18–75 with Wagner grade 1–3 diabetic foot ulcers (2–30 cm²) who meet the study’s TCM blood-stasis criteria and have HbA1c below 9%.
Not a fit: Patients with HbA1c ≥ 9%, severe organ failure, active malignancy, psychiatric disorders, pregnancy, very large or gangrenous ulcers, or who cannot attend the study visits are unlikely to qualify or benefit.
Why it matters
Potential benefit: If effective, adding electroacupuncture could speed wound closure and reduce complications such as infection or amputation.
How similar studies have performed: Small clinical and animal studies have suggested acupuncture or electroacupuncture can improve local blood flow and wound healing, but large randomized trials are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Meet the diagnostic criteria for diabetic foot ulcers; 2. Meet the criteria for Traditional Chinese Medicine syndrome differentiation, classified as blood stasis obstructing the collateral pattern; 3. Wagner Grade 1-3, with ulcer area ranging from 2 cm² to 30 cm²; 4. Male or female, aged between 18 and 75 years; 5. Provide signed informed consent, voluntarily participate in this study, and demonstrate good compliance. Exclusion Criteria: 1. Complicated with severe diseases of the brain, liver, heart, lungs, or kidneys; 2. Pregnant women or women planning to become pregnant; 3. Glycosylated hemoglobin (HbA1c) level ≥ 9%; 4. Complicated with psychiatric disorders; 5. Complicated with genetic or infectious diseases, malignant tumors, or other severe conditions associated with a short life expectancy; 6. Concurrent participation in other clinical trials or participation within 4 weeks prior to randomization.
Where this trial is running
Nanjing, Jiangsu
- Zongda Hospital affiliated to Southeast University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Dachun Chen
- Email: peoplechenda@126.com
- Phone: 13912992162
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.