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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Foot Care
• Intervention / Treatment: Procedure: Electroacupuncture at Zusanli (ST-36)

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dachun Chen; Phone Number: 13912992162; Email: peoplechenda@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Zongda Hospital affiliated to Southeast University
      • Contact: Huiping Wang; Phone Number: +86 25 83272015; Email: zdll2015@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care Group
Active Comparator: the electroacupuncture group; receive treatment at Zusanli every other day	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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wagner Grade and Ankle-Brachial Index (ABI) Measurement	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.	From enrollment to completion of all 4 treatment courses (each traatment courses is one week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic parameters (vascular inner diameter)	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.	From enrollment to completion of all 4 treatment courses (each traatment courses is one week)
Hemodynamic parameters (blood flow volume)	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.	From enrollment to completion of all 4 treatment courses (each traatment courses is one week)

Collaborators and Investigators

• Sponsor: Zhongda Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 15, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 15, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Diabetic Foot Ulcers; Electroacupuncture
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Ulcer; Skin and Connective Tissue Diseases; Diabetic Foot
• Other Study ID Numbers: 2025ZDSYLL128-P01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No