Diabetes Foot CareEA for DFUNCT07482137
Therapeutic Effect of Electroacupuncture at Zusanli (ST-36) on Diabetic Foot Wounds
A study testing Electroacupuncture at Zusanli (ST-36) in people with Diabetes Foot Care, run by Zhongda Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Foot Care
- What is being tested?
- Electroacupuncture at Zusanli (ST-36)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zongda Hospital affiliated to Southeast University
Nanjing, Jiangsu, 210009
Huiping Wang, +86 25 83272015, zdll2015@163.com
About this study
Official 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
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.
Read more
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
- Being tested
- Electroacupuncture at Zusanli (ST-36)
- Keywords
- Diabetic Foot Ulcers, Electroacupuncture
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture at Zusanli (ST-36)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| the electroacupuncture group | Active comparator | receive treatment at Zusanli every other day Receives: Procedure: Electroacupuncture at Zusanli (ST-36) |
| Usual Care Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to completion of all 4 treatment courses (each traatment courses is one week)
Secondary outcomes (2)
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.
Measured: 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.
Measured: From enrollment to completion of all 4 treatment courses (each traatment courses is one week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start15 Jul 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Foot CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dachun Chen, Zongda Hospital affiliated to Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482137
- Sponsor's protocol ID
- 2025ZDSYLL128-P01
- Acronym
- EA for DFU
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07482137
- Acronym / sponsor ID
- EA for DFU / 2025ZDSYLL128-P01
- Conditions
- Diabetes Foot Care
- Keywords
- Diabetic Foot Ulcers, Electroacupuncture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the electroacupuncture group | Active comparator | Procedure: Electroacupuncture at Zusanli (ST-36)receive treatment at Zusanli every other day |
| Usual Care Group | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | the electroacupuncture group |
Primary outcome
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.
2 secondary outcomes
Hemodynamic parameters (vascular inner diameter)
Time frame: From enrollment to completion of all 4 treatment courses (each traatment courses is one week)
Hemodynamic parameters (blood flow volume)
Time frame: From enrollment to completion of all 4 treatment courses (each traatment courses is one week)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture at Zusanli (ST-36) in people with Diabetes Foot Care, run by Zhongda Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dachun Chen (13912992162, peoplechenda@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.