Periosteal Distraction With Skin Grafting for DFU

Starting soon · Not applicable

Conditions studied: Diabetic Foot Disease, Wound Healing

In brief

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.

Key facts

Study ID

NCT07545668

Run by

Hu Zhicheng

People needed

104

Starts

2026-05-01

Expected to finish

2029-12-31

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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