Diabetic foot (DF)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-70 years old (male or female); 2. Clinically diagnosed with type 1 or type 2 diabetes; 3. Patients with diabetic foot Wagner grade 2-4; 4. Patients with foot ulcers > for 4 weeks and no healing tendency after one week of standard wound treatment; 5.7% 30mmHg; 7. Voluntarily sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1. Patients with renal insufficiency, hypercortisolism, thyroid dysfunction or other endocrine disorders; 2. Wound dissemination and infection: such as massive exudation, redness, swelling, heat and pain, etc., which have not been effectively controlled; 3. Active bleeding or hematoma in the wound; 4. Patients with severe cardiovascular disease, including uncontrollable hypertension (BP>=160/95mmHg), unstable angina, history of myocardial infarction within the past 6 months, congestive heart failure >NYHA class II., severe arrhythmias, and pericardial effusion, etc.; 5. Patients with systemic bacterial and viral infections (syphilis, hepatitis, CMV, HIV, parvovirus B19, herpes virus) and sepsis; 6. Patients with psychological or mental disorders, blood coagulation disorders, and patients with a history of allergies; 7. Other situations that the investigator considers unsuitable for enrollment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound area change rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Amputation rate;Visual Analog Scale (VAS) for pain;Bates-Jensen Wound Assessment Tool;Adverse events evaluation;Complete healing rate;Ankle-brachial index (ABI);Transcutaneous oxygen pressure (TcPO?);Toe oxygen saturation; | — |
Countries
China
Contacts
Affiliated Hospital of Shandong University of Traditional Chinese Medicine