Therapeutic Effect of Electroacupuncture at Zusanli (ST-36) on Diabetic Foot Wounds
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electroacupuncture at Zusanli (ST-36).
- Who it may be relevant to
- Registry conditions: Diabetes Foot Care. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
The goal of this clinical trial is to learn if electroacupuncture at the Zusanli (ST-36) can assist in the treatment of diabetic foot ulcers. The main question it aims to answer is: Can electroacupuncture at the Zusanli (ST-36) promote wound healing in patients with diabetic foot ulcers? Researchers will compare outcomes between participants receiving electroacupuncture plus standard treatment and those receiving standard treatment alone to assess the effect of Zusanli (ST36) stimulation on wound healing in patients with diabetic foot ulcers. Participants will: Receive standard diabetes treatment (including diabetes education, dietary control, insulin combined with oral hypoglycemic agents to manage blood glucose, and effective antibiotics to control infection. For patients with foot ulcers, the wound will be cleaned with saline; abscesses will be drained if present; daily dressing changes.) Participants in the electroacupuncture group will receive electroacupuncture at Zusanli(ST-36) every day; 6 sessions constitute one treatment course, for a total of 4 courses. Visit the hospital for examinations before treatment and after each treatment course to measure the ankle-brachial index (ABI), assess diabetic foot Wagner grade, and evaluate hemodynamic parameters.
Interventions
- Procedure Electroacupuncture at Zusanli (ST-36)
The primary acupuncture point is Zusanli (ST-36). Depending on the location of the gangrenous lesion, 1 to 2 additional local acupoints are chosen on intact skin near the affected area as adjunct points. After routine sterilization of the acupoint area, disposable sterile acupuncture needles (0.3 × 40 mm) are inserted perpendicularly to a depth of approximately 1 cun. An XS-998C photoelectric therapy device is used with a dense-sparse wave at frequency setting f1. The current intensity is adjust
Primary outcome measures
- Wagner Grade and Ankle-Brachial Index (ABI) Measurement [Time frame: From enrollment to completion of all 4 treatment courses (each traatment courses is one week)]
Secondary outcome measures (2)
- Hemodynamic parameters (vascular inner diameter) [Time frame: From enrollment to completion of all 4 treatment courses (each traatment courses is one week)]
- Hemodynamic parameters (blood flow volume) [Time frame: From enrollment to completion of all 4 treatment courses (each traatment courses is one week)]
Eligibility criteria
Inclusion criteria
- Meet the diagnostic criteria for diabetic foot ulcers;
- Meet the criteria for Traditional Chinese Medicine syndrome differentiation, classified as blood stasis obstructing the collateral pattern;
- Wagner Grade 1-3, with ulcer area ranging from 2 cm² to 30 cm²;
- Male or female, aged between 18 and 75 years;
- Provide signed informed consent, voluntarily participate in this study, and demonstrate good compliance.
Exclusion criteria
- Complicated with severe diseases of the brain, liver, heart, lungs, or kidneys;
- Pregnant women or women planning to become pregnant;
- Glycosylated hemoglobin (HbA1c) level ≥ 9%;
- Complicated with psychiatric disorders;
- Complicated with genetic or infectious diseases, malignant tumors, or other severe conditions associated with a short life expectancy;
- Concurrent participation in other clinical trials or participation within 4 weeks prior to randomization.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zongda Hospital affiliated to Southeast University — Nanjing
Identifiers
NCT: NCT07482137 · 2025ZDSYLL128-P01