Diabetic Foot Disease, Wound Healing
Conditions
Brief summary
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.
Interventions
PROCEDUREPeriosteal Distraction
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.
PROCEDURESkin Grafting
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.
Sponsors
Hu Zhicheng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graft Survival Rate | Day 14 post-surgery | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Complete Epithelialization | Assessed daily from surgery until closure, up to 3 months | 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. |
| Wound Healing Quality Assessed by BWAT Score | Month 3 post-surgery | 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. |
| Ulcer Recurrence Rate | Month 6 post-surgery | 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. |
| Foot and Ankle Function Assessed by AOFAS Score | Month 6 post-surgery | 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. |
| Quality of Life Assessed by DFS-SF Score | Month 6 post-surgery | 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. |
Contacts
CONTACTHu Zhicheng
Outcome results
None listed