Wagner Grade 3-4 Diabetic Foot Ulcers
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. adults aged 18 to 80 years with a confirmed diagnosis of diabetes mellitus; 2. presence of a Wagner grade 3 or 4 DFU that has failed to respond to standard conservative treatment; 3. foot ulcer area greater than 1 cm^2 with a duration of non-healing exceeding 6 weeks; 4. relatively stable glycemic control, defined as glycated hemoglobin (HbA1c) <= 8%; 5. ability to understand the study procedures and provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1. severe comorbid conditions, such as significant cardiac disease or severe hepatic or renal dysfunction; 2. severe lower-extremity ischemia or irreversible peripheral arterial disease; 3. prior foot surgery or the presence of foot malignancy; 4. pregnancy or breastfeeding; 5. inability to comply with the study protocol or complete effective follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ulcer healing rate;Postoperative complication rates; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain;quality-of-life;Imaging assessments;Patient adherence; | — |
Countries
China
Contacts
Taizhou Hospital of Zhejiang Province