Periosteal Distraction With Skin Grafting for DFU

Inclusion criteria

• 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.
• Wound area ≥3 cm².
• Brachial-ankle index between 0.71 and 1.30.
• Hemodynamically stable with routine examinations indicating tolerance to surgery.
• Mentally competent, able to follow medical advice, and willing to attend scheduled follow-up visits.
• Understand and voluntarily sign informed consent to participate in this trial.

Exclusion criteria

• 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.
• Psychiatric disorders.
• Deemed unsuitable for inclusion by the investigator.
• Pregnancy, unwillingness to use adequate contraception in women of childbearing potential, lactation, or planning pregnancy within 1 month after study completion.
• Active osteomyelitis in the target ulcer without adequate debridement and/or antibiotic treatment.
• Significant uncorrected biomechanical deformity expected to severely affect graft survival and function.
• Active bleeding or significant coagulation abnormality.
• Previous participation in this study at any time.