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

NCT07482137 | Recruiting

• 1 other identifier: 2025ZDSYLL128-P01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Foot Care

Keywords

Diabetic Foot Ulcers; Electroacupuncture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Hemodynamic parameters (vascular inner diameter)

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

• Hemodynamic parameters (blood flow volume)

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

Study Arms (2)

the electroacupuncture group

ACTIVE COMPARATOR

receive treatment at Zusanli every other day

Procedure: Electroacupuncture at Zusanli (ST-36)

Usual Care Group

NO INTERVENTION

Interventions

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.

the electroacupuncture group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zongda Hospital affiliated to Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Dachun Chen

CONTACT

13912992162; peoplechenda@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician of Traditional Chinese Medicine

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 19, 2026
• Study Start: July 15, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CN (1)