Randomized Clinical Trial to Determinate the Effectiveness and Safety of Plasma Rich Growth Factors (PRGF) in Venous Ulcers Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Ulcers closed
研究概览
简要总结
OBJECTIVES: Main objective: To evaluate the effectiveness of plasma rich in growth factors (PRGF) in the treatment of patients with venous ulcers. Secondary objective: To evaluate the safety of plasma rich in growth factors in treating patients with venous ulcers. DESIGN: Randomized, open clinical trial in parallel groups, controlled with conventional treatment.
SAMPLE: Over age patients, of primary care centers of Vitoria, with at least one venous ulcers of 6 or more weeks of evolution and 0.5-6 cm of diameter. INTERVENTION: 1-Experimental group: Autologous PRGF administrated once a week (day 1) + conventional treatment administrated twice a week (days 1 and 4)for 12 weeks of treatment, but in those cases where there has been no complete healing in this period, patients will continue the same management protocol to get it. 2-Control group: Conventional treatment twice a week (days 1 and 4)for 12 weeks of treatment.
Conventional treatment includes: Cleaning and debridement of the wound, the application of corresponding dressing, and using of antibiotic if necessary in each visit.
STATISTICAL ANALYSIS:The primary outcome analysis was done by logistic regression. The crude model and the adjusted model (for confounding variables)will be built. The healing time of ulcers (in days) were analyzed using the Kaplan Meier survival analysis and the corresponding comparison using the log rank test.
详细描述
An open, randomized, of parallel groups, and controlled clinical trial. Patients will be allocated on first come to one of the two treatment groups using a block random sequence generated by computer that will remain hidden from the researchers and patients until allocation.
Experimental group: PRGF together with the corresponding dressing according to annex IV.
Control group: Corresponding dressing according to annex IV.
Both groups will be submitted to a cleaning, debridement, occlusive dressing and use of antibiotic if necessary in each visit.
After signing consent form, and previously of randomization, patients will be submitted to a blood extraction where it will be determinate: Albumine (in g/dl), Hemoglobin (in g/dl), Hematocrit (in %), Creatinine (in mg/dl). If patients have data collected through previous analysis performed until 30 days before, it will not be necessary a new extraction.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years.
- •Patients with at least one venous ulcer of at least 6 weeks of evolution.
- •Diameter between 0,5-6cm.
排除标准
- •Cutaneous ulcers with an arterial and/or mixed origin.
- •Ankle-arm index <0.
- •Concomitant terminal disease with bad prognosis.
- •Hematologic several abnormalities (anemia with hemoglobin <11g/dl, hematocrit <34%, lymphomas and leukemias).
- •Antineoplastic or immunosuppressive treatment.
- •Solid tumors.
- •Nutritional status affectation.
- •Known peripheral neuropathy in patients with diabetes mellitus.
- •At home patient.
结局指标
主要结局
Ulcers closed
时间窗: at 12 weeks of treatment
Patients will be followed during 12 weeks.
次要结局
- Pruritus (Yes/No)(During 12 weeks of treatment (in each visit))
- Pain (through VAS scale)(During 12 weeks of treatment (in each visit))
- Signs of infection (Yes/No)(During 12 weeks of treatment (in each visit))
- Wound surface (in cm2) measured through PUSH scale(Every 4 days)
研究者
Javier Urraca García de Madinabeitia
Primary care Physician
Basque Health Service