Diabetic Foot Ulcers
Conditions
Interventions
A:Negative Pressure Wound Therapy
B:Advanced Wound Dressing Treatment
Sponsors
Dept. of Endocrinology & Metabolism, Nanfang Hospital, Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with type I diabetes mellitus or type II diabetes mellitus; 2. Patient with diabetic foot ulcers (DFUs) including amputation wound is suitable for NPWT by the researcher of this study; 3. The wound area of the ulcer is 3-10 cm2 and has been there for more than a week; 4. Patient between the age of 18 to 80; both gender; 5. Good blood circulation on part of the wound bed (ABI 0.7 to 1.2); 6. Understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Patient with severe hepatic and renal dysfunction(GPT>2*ULN, Upper Limits of Normal; Cr>2*ULN) or unsatisfactory control of blood sugar(Hb1A1c>12%); 2) Patient with severe hypoproteinemia(TP<60g/L) or anemia(Hb<100g/L); 3) Patient with uncontrolled osteomyelitis or cellulites; 4) Malignancy is suspected in or at the edge of the wound bed; 5) Unexposed fistula in part of the wound bed needs to be debrided after the patient is selected; 6) Patient with exposed major vascular, organs or nerves in part of the wound bed; 7) Incontrollable active bleeding in part of the wound bed; 8) Technically it is difficult to succeed if the wound can not be vacuum; such problem may due to the ulcer area or other reason; 9) Patient has already had NPWT experience in the early 48 hours before he is selected; 10) Patient has already treated by growth factor, hyperbaric oxygen therapy, thermal therapy or Vacuum Assisted Closure before he is selected; 11) Patient under Chemotherapy or radiation therapy, or has been treated by these therapies in the past three months; 12) Patient is highly sensitive to foam dressing material; 13) Patients non-compliance with clinical observation plan is expected; 14) Patient is pregnant; 15) Patient under other clinical experiment, or has been tested by other experiment in the past thirty days (experiment by device or medicine).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in wound area of diabetic foot ulcer over a 4-week period; | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess complete healing rate of diabetic foot ulcer over a 4-week period;To measure time required to complete healing of diabetic foot ulcer;To record all adverse events in the treatment; | — |
Countries
China
Contacts
Public ContactXue Yaoming
Outcome results
None listed