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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
A minimally invasive surgical technique based on the Ilizarov tension-stress principle. The periosteum is circumferentially stripped 1-1.5 cm from the wound edge, elevated 0.5-1.0 cm using K-wire drilling and suspension, followed by biological material coverage to promote vascularization. The distraction is applied at a rate of 1 mm per day to activate cell proliferation and angiogenesis.
Autologous split-thickness skin harvested using a dermatome, trimmed to match the wound size, and transplanted onto the wound bed after debridement. The graft is secured with vaseline gauze and antibiotic dressing, followed by pressure bandaging and splint immobilization.
Graft Survival Rate
Survival area of skin graft as a percentage of the original graft area at postoperative day 14. Measured using a transparent grid film (1 cm² grid) combined with digital photography. Two blinded assessors independently measure the area; a third assessor arbitrates if the difference exceeds 10%. Formula: (surviving graft area / initial graft area) × 100%.
Time frame: Day 14 post-surgery
Time to Complete Epithelialization
Number of days from surgery to complete wound closure, defined as 100% epithelial coverage without drainage or scab. Assessed daily by clinical examination combined with digital photography.
Time frame: Assessed daily from surgery until closure, up to 3 months
Wound Healing Quality Assessed by BWAT Score
Bates-Jensen Wound Assessment Tool (BWAT) score at 3 months post-surgery. The scale ranges from 13 to 65 points, with higher scores indicating poorer wound healing quality. Assessed by blinded independent outcome assessors.
Time frame: Month 3 post-surgery
Ulcer Recurrence Rate
Proportion of participants developing a new ulcer ≥1 cm² at the original graft site within 6 months post-surgery. Confirmed by clinical examination and photographic documentation.
Time frame: Month 6 post-surgery
Foot and Ankle Function Assessed by AOFAS Score
American Orthopaedic Foot and Ankle Society (AOFAS) score at 6 months post-surgery. The scale ranges from 0 to 100 points, with higher scores indicating better functional recovery. Assessed by blinded independent outcome assessors.
Time frame: Month 6 post-surgery
Quality of Life Assessed by DFS-SF Score
Diabetic Foot Ulcer Scale Short Form (DFS-SF) score at 6 months post-surgery. The scale ranges from 0 to 100 points, with higher scores indicating better quality of life. Assessed by blinded independent outcome assessors.
Time frame: Month 6 post-surgery
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