About this trial
This study is a single-center, prospective, randomized controlled trial aimed at evaluating whether periosteal distraction combined with autologous split-thickness skin grafting can significantly improve graft survival rate at postoperative day 14 compared with skin grafting alone in patients with diabetic foot ulcers (Wagner grade 2-3 or post-amputation). A total of 104 eligible patients will be randomly assigned to either the experimental group (periosteal distraction + skin grafting, n=52) or the control group (skin grafting alone, n=52). Secondary outcomes include time to complete epithelialization, wound healing quality (BWAT score at 3 months), ulcer recurrence rate (at 6 months), foot function (AOFAS score), quality of life (DFS-SF score), and safety profile. This study aims to address the critical clinical bottleneck of poor graft survival in ischemic wound environments, providing a novel, minimally invasive, and synergistic treatment paradigm for diabetic foot ulcers.
Eligibility criteria
Qualifiers
Age ≥18 years on the day of signing informed consent.
Diagnosed with type 2 diabetes mellitus.
Diabetic foot ulcer persisting for ≥2 weeks.
Wagner grade 2 or 3; or post-amputation (Wagner grade 4-5) wound requiring skin grafting.
Disqualifiers
Poorly controlled hyperglycemia (e.g., HbA1c >12.0%).
Immunosuppression due to underlying disease, long-term immunosuppressive therapy, or high-dose glucocorticoids (e.g., ≥40 mg prednisone or equivalent daily for ≥2 weeks) during screening.
Preexisting conditions affecting wound healing (e.g., malignancy, autoimmune disease).
Severe uncontrolled systemic disease or acute systemic infection; concomitant severe cardiac, pulmonary, or cerebral disease.
Trial design
Treatments tested in this trial
- Periosteal Distraction
- Skin Grafting
Treatment groups
Locations
Sponsors and collaborators
Hu Zhicheng
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
Sponsor institution