Periosteal Distraction Combined With Skin Grafting for the Treatment of Diabetic Foot Ulcers: A Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 主要终点
- Graft Survival Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •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.
研究组 & 干预措施
Periosteal Distraction + Skin Grafting
Patients receive periosteal distraction combined with autologous split-thickness skin grafting. Surgical procedure includes debridement, periosteal stripping and elevation (0.5-1.0 cm) using K-wire drilling, biological material coverage for vascularization, skin graft fixation, and postoperative management with delayed dressing change at day 5-7 and suture removal at day 14.
干预措施: Periosteal Distraction (Procedure)
Periosteal Distraction + Skin Grafting
Patients receive periosteal distraction combined with autologous split-thickness skin grafting. Surgical procedure includes debridement, periosteal stripping and elevation (0.5-1.0 cm) using K-wire drilling, biological material coverage for vascularization, skin graft fixation, and postoperative management with delayed dressing change at day 5-7 and suture removal at day 14.
干预措施: Skin Grafting (Procedure)
Skin Grafting Alone
Patients receive autologous split-thickness skin grafting alone. Surgical procedure includes debridement, skin graft harvesting and transplantation, followed by postoperative management with first dressing change at day 3, suture removal at day 10-14, and gradual weight-bearing after ≥4 weeks.
干预措施: Skin Grafting (Procedure)
结局指标
主要结局
Graft Survival Rate
时间窗: 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%.
次要结局
- Time to Complete Epithelialization(Assessed daily from surgery until closure, up to 3 months)
- Wound Healing Quality Assessed by BWAT Score(Month 3 post-surgery)
- Ulcer Recurrence Rate(Month 6 post-surgery)
- Foot and Ankle Function Assessed by AOFAS Score(Month 6 post-surgery)
- Quality of Life Assessed by DFS-SF Score(Month 6 post-surgery)
研究者
Hu Zhicheng
The First Affiliated Hospital of Sun Yat-sen University
First Affiliated Hospital, Sun Yat-Sen University