Diabetic Foot
Conditions
Interventions
Conventional treatment group:Before the necrotic tissue of the wound was completely removed, the wound was rinsed with 3% hydrogen peroxide solution, then rinsed with normal saline injection, and debr
A-PRF treatment group:Before the necrotic tissue of the wound was completely removed, the wound was rinsed with 3% hydrogen peroxide solution, then rinsed with normal saline injection, and debridement
Sponsors
Air Force Medical Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Agree to participate in the clinical trial and sign the informed consent form; 2) Patients with diabetic foot of Wagner grade 2 to 4; 3) 0.3 <= ABI < 1.3; 4) The course of diabetic foot ulcer exceeds 4 weeks; 5) Diabetic foot ulcer with exposure of bone, tendon or joint capsule; 6) The exposed area of bone, tendon or joint capsule is less than 10 cm²; 7) Age 18 to 80 years old; 8) According to the standards of the Infectious Diseases Society of America (IDSA), there are no clinical signs of infection in the diabetic foot ulcer.
Exclusion criteria
Exclusion criteria: 1) Sepsis or septicemia; 2) Skin ulcers caused by other reasons such as electrochemistry, radiation, tumors, etc., atypical ulcers but cannot rule out arteritis and basal cell carcinoma; 3) Those who have used radiotherapy, hormones, chemotherapy, growth factors, platelet gel dressings and immunosuppressants within the past month; 4) Those with severe cardiovascular and cerebrovascular diseases; 5) Those with infectious diseases such as hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection; 6) Pregnant or lactating women; 7) Those with severe coagulation disorders and hematological diseases; 8) Estimated glomerular filtration rate (eGFR) (based on serum creatinine) < 20 ml/min/1.73 m^2 or undergoing dialysis treatment; 9) Hemoglobin < 90g/L.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of complete coverage of bone/tendon/joint capsule by granulation tissue at 4 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time for granulation tissue to completely cover bone/tendon/joint capsule;Wound healing rate at 12 weeks;Extent of wound area reduction during observation period;Incidence of secondary infection;Time of antibiotic use after enrollment;Major amputation rate at 12 weeks;Small amputation rate at 12 weeks;Quality of life and pain of dressing change;Treatment cost during the observation period after enrollment; | — |
Countries
China
Contacts
Public ContactZhu Di
Air Force Specialty Medical Center
Outcome results
None listed