None listed
Conditions
Interventions
Medical Device : 1. Control group : Apply NPWT -60~80mmHg and change dressing every other days Until granulation tissue is formed and closed the wound by sutures, skin grafts, and flaps.
2. Experiment
Sponsors
Ajou University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are 18 years of age or older 2. Patients who had diagnosis of type 1 or type 2 diabetes with at least one nonhealing neuropathic or vasculopathic foot ulcer that failed following a minimum of four weeks of conservative care prior to study enrollment. 3. Patients who have foot ulcers of stage 2 or higher on Wagner’s scale and require operative intervention. * If a single patient had multiple wounds, we selected the deepest wound. 4. Subjects who have agreed to participate in this clinical trial
Exclusion criteria
Exclusion criteria: 1. inadequate nutrition as assessed by a blood sample of serum albumin with a value less than 2.0 g/dL 2. malignancy 3. autoimmune disease 4. using long-term corticosteroids or immunosuppressants 5. uncontrolled hyperglycemia (preoperative HbA1c >15.0%) * patients who had undergone amputation above the level of the study wound.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| granulation tissue formation (%);complete wound healing rate (%) | — |
Secondary
| Measure | Time frame |
|---|---|
| proportions of wounds that were surgically closed or covered without complications or that were completely healed;proportions of wounds that were surgically closed or covered without complications or that were completely healed;intervals between study enrollment and surgical coverage;Adverse events included wound infection, surgical complications | — |
Countries
Korea, Republic of
Contacts
Public ContactIl Jae Lee
Ajou University
Outcome results
None listed