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A multicenter parallel-controlled clinical study on the effectiveness and safety of radiofrequency electric field intervention for microcirculation disorders in diabetic lower extremities

A multicenter parallel-controlled clinical study on the effectiveness and safety of radiofrequency electric field intervention for microcirculation disorders in diabetic lower extremities

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105072
Enrollment
Unknown
Registered
2025-06-27
Start date
2024-10-01
Completion date
Unknown
Last updated
2025-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic lower extremity microcirculation disorder

Interventions

Sponsors

Zhongda Hospital Affiliated to Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Those who meet all the following conditions can be selected for observation: 1 Age between 18 and 75 years old (inclusive), gender not restricted; 2 Systolic oxygen pressure measured by percutaneous method is within the range of 10 mmHg <= X < 40 mmHg. 3 The patient is taking basic medications related to microcirculation and the dosage should be stable for 3 months. 4 Good compliance and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: Any of the following conditions must be excluded: 1 Individuals with implanted metals in their bodies. 2 Patients with lower limb ulcers and concurrent infections. 3 Patients with deep vein thrombosis in the lower limbs (including those with a history of thrombosis) or acute arterial thrombosis. 4 Patients with an ABI value less than 0.4. 5 Patients with grade 3 (inclusive) or higher congestive heart failure. 6 Patients with a history of bleeding, such as hemophilia, fragile capillaries, upper gastrointestinal bleeding, hemoptysis, etc. 7 Patients who have experienced acute complications of diabetes within 6 months prior to screening, such as diabetic ketoacidosis, lactic acidosis, hyperosmolar hyperglycemic syndrome, diabetic hyperosmolar coma or severe hypoglycemia (blood glucose <= 2.9 mmol/L or hypoglycemia that cannot be managed by themselves). 8 Patients who have experienced myocardial infarction, cerebral infarction, or cerebral hemorrhage within 6 months prior to screening. 9 Patients who are currently participating in other clinical trials within 3 months prior to screening. 10 Pregnant, lactating women or those who plan to become pregnant during the observation period.

Design outcomes

Primary

MeasureTime frame
transcutaneous oxygen pressure;

Secondary

MeasureTime frame
Ankle-brachial index;Ultrasound Doppler (for both lower extremities - arteries and veins);Toronto Clinical Scoring System (TCSS);

Countries

China

Contacts

Public ContactZiLin Sun

Zhongda Hospital Affiliated to Southeast University

sunzilin1963@126.com+86 139 5174 9490

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026