Prospective Randomized Clinical Trial Comparing Efficacy Surgical Versus Medical Treatment of Osteomyelitis in Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Number of healing patients
研究概览
简要总结
Hypothesis:Surgical treatment of osteomyelitis in diabetic foot is more effective that medical treatment through antibiotherapy and leads wound healing in ulcers complicated with bone infection.Material and Methods: Randomized clinical trials which include two groups of patients (n=88), one receives medical treatment through antibiotherapy during 90 days and the other group receive conservative surgical treatment and antibiotics during 7 days after surgery. It will be studied differences between both groups in healing time, recidives, present and relationship of adverse events and outflow of quality of life related health .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Diabetes Mellitus Type 1 or
- •Patients with diabetic foot ulcers.
- •Patients with clinical suspects of osteomyelitis.
- •Patients with positive probe to bone test.
- •Patients with signs of osteolysis in the bone located adjacent to the ulcer in X-Ray
- •Patients with transcutaneous oxygen oxygenation above 30 mmHg.
- •Acceptance to participate in the study through prior informed consent.
排除标准
- •Patients with osteomyelitis associated with necrotizing soft tissue infections.
- •Presence of necrotic tissue in the wound bed, edges or margins of the lesion.
- •Presence of systemic toxicity such as fever, tachycardia, confusion, disorientation, vomiting or other signs usually related to systemic infection.
- •Patients with bone exposure through the ulcer.
- •Patients with absent pulses, ankle/brachial index (ABI) <0.8 and TcPO2 <30 mmHg.
- •Pregnancy.
- •Allergies to antibiotics.
- •Any degree of renal impairment that contraindicated the administration of antibiotics proposed.
- •Hepatic insufficiency.
- •Mental Illnesses that prevent the understanding by the patient's proposed treatment, or for any other reason associated with your mental health, to recommend their inclusion.
研究组 & 干预措施
Patients undergoing medical treatment
Antibiotic treatment within 90 days with:
Ciprofloxacin Amoxicillin /Clavulanic acid. Trimethoprim /Sulfamethoxazole.
干预措施: Ciprofloxacin (Drug)
Patients undergoing medical treatment
Antibiotic treatment within 90 days with:
Ciprofloxacin Amoxicillin /Clavulanic acid. Trimethoprim /Sulfamethoxazole.
干预措施: Amoxicillin-Potassium Clavulanate Combination (Drug)
Patients undergoing medical treatment
Antibiotic treatment within 90 days with:
Ciprofloxacin Amoxicillin /Clavulanic acid. Trimethoprim /Sulfamethoxazole.
干预措施: Sulfamethoxazole trimethoprim (Drug)
Patients undergoing surgical treatment
Conservative surgical Minor amputation 7 days antibiotic after surgical
干预措施: Conservative surgery (Procedure)
结局指标
主要结局
Number of healing patients
时间窗: 12 weeks
Number of diabetic foot ulcers healing in both arms.
次要结局
- Reulceration(1 year after healing)
- Healing time(12 weeks)
- Complications(12 weeks)
- Quality of life(12 weeks)