Diabetic lower extremity microcirculation disorder
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| transcutaneous oxygen pressure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ankle-brachial index;Ultrasound Doppler (for both lower extremities - arteries and veins);Toronto Clinical Scoring System (TCSS); | — |
Countries
China
Contacts
Zhongda Hospital Affiliated to Southeast University