A Clinical Trial Testing the Efficacy of PDT in Preventing Amputation in Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 主要终点
- Infection control
研究概览
简要总结
The feet of diabetic patients continue to be an important problem in medicine. In general, patients with diabetic foot have some sort of amputation, especially in underserved populations. It is clearly necessary to develop novel treatment strategies for this worldwide health problem. Photodynamic therapy (PDT) , is a low cost and highly effective alternative treatment concerning infections avoiding amputations in the diabetic foot.
详细描述
Patients with infected diabetic foot were grouped according to the Wagner system for classifying foot lesions. All patients presented Wagner Grade 3 classification, with osteomyelitis in one or more toes. The study included only patients who had circulatory viability.
For PDT treatment the fistula and/or ulcer was used as a gateway to the bone. The treated area (bones and fingers) was irrigated with a solution of phenothiazinium salts. After that, light irradiation was performed with optical fibers or led device above the wound. PDT treatment always in outpatients, once or twice a week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 83 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age > 18 years old
- •diabetic foot
- •Wagner grade III
排除标准
- •age < 18 years old
- •non-diabetic
- •Wagner IV and V
研究组 & 干预措施
Ciprofloxacin
Diabetic foot patients were treated on conventional way, using antibiotics and surgery.
干预措施: Ciprofloxacin (Other)
PDT
Methylene blue and Photon Irradiation , every each week, until total ulcer healing.
干预措施: PDT (Radiation)
结局指标
主要结局
Infection control
时间窗: every month until three months , when blood count- leucocytes reach the standard value.
blood count - leucocytes for infection
次要结局
- Osteomyelitis evaluation(once a month, until three months, when X-ray shows bone reconstitution .)
研究者
João Paulo Tardivo
Principal Investigator
Faculdade de Medicina do ABC