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NCT Number: NCT07482137

Therapeutic Effect of Electroacupuncture at Zusanli (ST-36) on Diabetic Foot Wounds

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.

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Key information

Conditions

Diabetes Foot Care Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zongda Hospital affiliated to Southeast University

Nanjing, Jiangsu, 210009, China

Location status: Recruiting

Location contact

Huiping Wang

CONTACT

[email protected]

+86 25 83272015

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electroacupuncture at Zusanli (ST-36)

Procedure

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 adjusted to a level tolerable for the participant. Treatment is administered for 6 consecutive days, followed by a 1-day break. A total of 4 weeks constitutes one treatment course.

Primary outcomes

  1. 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)

    Wagner grade and ankle-brachial index (ABI) are measured before treatment and after each treatment course.

    The outcomes are defined as follows:

    Cure: A decrease of two grades in the Wagner classification, ABI > 1.0, stable diabetes status, and complete resolution of clinical symptoms.

    Improvement: A decrease of one grade in the Wagner classification, 0.5 ≤ ABI ≤ 1.0, and significant improvement of clinical symptoms.

    No improvement: No significant improvement or worsening of the patient's condition after treatment.

Secondary outcomes

  1. Hemodynamic parameters (vascular inner diameter)

    Time frame: From enrollment to completion of all 4 treatment courses (each traatment courses is one week)

    Hemodynamic parameters of the dorsalis pedis artery (vascular inner diameter) was measured using a color Doppler ultrasound system (probe frequency: 7.5-12 MHz) at a point 3 cm distal to the ankle joint.

  2. Hemodynamic parameters (blood flow volume)

    Time frame: From enrollment to completion of all 4 treatment courses (each traatment courses is one week)

    Hemodynamic parameters of the dorsalis pedis artery (blood flow volume) was measured using a color Doppler ultrasound system (probe frequency: 7.5-12 MHz) at a point 3 cm distal to the ankle joint.

Study contacts

Contact information is provided by the study sponsor or research team.

Dachun Chen

CONTACT

[email protected]

13912992162

Sponsors and collaborators

Lead sponsor

Zhongda Hospital

Other

Registry information

Official study 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

Acronym: EA for DFU

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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