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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the electroacupuncture group | Active Comparator | receive treatment at Zusanli every other day |
|
| Usual Care Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dachun Chen | Contact | 13912992162 | peoplechenda@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zongda Hospital affiliated to Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| 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) |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |