Diabetes Foot Care
Conditions
Keywords
Diabetic Foot Ulcers, Electroacupuncture
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.
Interventions
PROCEDUREElectroacupuncture 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.
Sponsors
Zhongda Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wagner Grade and Ankle-Brachial Index (ABI) Measurement | 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
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic parameters (vascular inner diameter) | 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. |
| Hemodynamic parameters (blood flow volume) | 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. |
Countries
China
Contacts
CONTACTDachun Chen
Outcome results
None listed