Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery in a Cross-sectional Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Score change of the AOFAS Hallux metatarsophalangeal interphalangeal scale
研究概览
简要总结
Despite the development of the control of DM and the great interest for the complications of the disease, even today the diabetic foot represents a challenge for the orthopaedic surgeon. Being frequently correlated to alteration of the plantar pressures, the surgery treatment is recommended and the Minimally Invasive Surgery (MIS) candidates itself to solve this pathologic case.
The purpose of this longitudinal cross-sectional study was to evaluate radiographic and surgical outcomes and the subjective grade of satisfaction of the patients with a diagnosis of chronic plantar diabetic foot ulcers that have been treated at Padua's Orthopaedic Clinic through MIS.
详细描述
Thirty-two patients with chronic diabetic foot ulcers (CDFUs) were treated by MIS between January 2010 and September 2016. Clinical evaluation was assessed pre-operatively, as well as at 3 months after surgery and at final follow-up, using the American Orthopaedic Foot and Ankle Society (AOFAS) Hallux Metatarsophalangeal-Interphalangeal Scale. The recurrence of the ulcers and complications were recorded. All the ulcers were evaluated with the University of Texas Diabetic Wound Classification. We used the radiological Maestro's criteria to evaluated the radiographs before and after the operation. Also, the bridging bone/callus formation was evaluated at the different radiographic follow-ups, while the articular surface congruency. The global disability was evaluated with the Short Form Health Survey (SF-36) and the satisfaction's level with the Visual Analogue Scale (VAS). Statistical analysis was carried out using the Wilcoxon signed-rank test. Statistical significance was set at p < 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of DM;
- •presence of a plantar CDFU, so not healed after 6 months of medical multidisciplinary treatment;
- •HbA1c < 8,5%.
排除标准
- •congenital deformities of the foot;
- •macroscopic signs of local infection of the soft tissues;
- •alteration of CRP>150 mg/L;
- •previous foot and ankle surgery;
- •previous foot and ankle surgery;
- •rheumatic, neurologic, infective, or psychiatric pathologies.
结局指标
主要结局
Score change of the AOFAS Hallux metatarsophalangeal interphalangeal scale
时间窗: From 1 month before the operation until study completion, an average of 2 years.
Total between 0 to 100.
次要结局
- Radiological outcomes changes after surgical treatment(Preoperative and at 3-6-12 months post-operative)
- Change in clinical evaluation with SF-36 score(From 1 month before the operation until study completion, an average of 2 years.)
- Change in clinical evaluation with VAS(From 1 month before the operation until study completion, an average of 2 years.)
研究者
Carlo Biz
MD, Assistant Professor
University of Padova