Periosteal Distraction With Skin Grafting for DFU
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorHu Zhicheng
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Periosteal Distraction
Procedure/SurgeryA 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.
Skin Grafting
Procedure/SurgeryAutologous 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.
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: Periosteal Distraction + Skin GraftingExperimental treatment 2 interventions
Group B: Skin Grafting AloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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-surgerySecondary outcomes
1
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 months2
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-surgery3
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-surgery4
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-surgeryLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hu Zhicheng
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
Sponsor institution
Source ClinicalTrials.gov
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