Investigation of the Effect of Platelet Rich Fibrin (PRF) Application on Wound Healing in Diabetic Foot Wound
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 14
- 主要终点
- Wound Observation and Evaluation Form
研究概览
简要总结
This study was planned as a prospective case-control study to examine the effect of PRF application on wound healing in diabetic foot wound. The sample of the study will consist of patients with diabetic foot wounds, who met the inclusion criteria and agreed to participate in the study. It is planned to include 7 patients for the experimental group and 7 patients for the control group (14 patients in total). If the patient is in the experimental group, PRF will be applied to the diabetic foot wound, and in the control group, classic wound dressing (CWD) will be applied.
详细描述
Foot ulcer is a common complication in diabetic patients, in some cases requiring hospitalization and may result in amputation. Effective treatment and care of diabetic foot is as important as prevention. For this reason, the condition of the wound should be evaluated well, effective wound care materials should be used, and current evidence-based practices should be included in treatment and care. One of these current applications is PRF. In the literature, the success and positive effects of PRF applications on dentistry, plastic surgery, orthopedics, eye surgery, diabetic foot, chronic arterial and venous ulcers, and complex wounds that are difficult to heal have been reported.
This study was planned as a prospective case-control study to examine the effect of PRF application on wound healing in diabetic foot wound. The population of the study will consist of patients with diabetic foot wounds, who applied to Bolu Home Health Services affiliated to the Republic of Turkey Ministry of Health Bolu Provincial Health Directorate, and who were followed up in the center of Bolu.
The sample of the study will consist of patients with diabetic foot wounds, who met the inclusion criteria and agreed to participate in the study. It is planned to include 7 patients for the experimental group and 7 patients for the control group (14 patients in total). Before starting the study, patients will be randomized in a computer program (random.org). According to the randomization results of the program, the patients in the first column will be the experimental group and the patients in the second column will be the control group. If the patient is in the experimental group, PRF will be applied to the diabetic foot wound, and in the control group, classic wound dressing (CWD) will be applied.
PRF Preparation and Application Technique (To be applied to the experimental group):
10 ml blood will be collected into a tube without anticoagulant with an injector or a vacutainer directly, from the patients included in the experimental group. Then, centrifugation will be carried out immediately at 3000 (rpm) speed for 10 minutes. This process will be applied by the researcher next to the patient by using a Yuda 800D brand desktop type centrifuge device with 6 tube capacity, 500-4000 rpm speed setting and 5-30 minutes time setting. After this procedure, the tube will be removed from the device and the PRF clot formed in the middle of the tube will be removed with forceps. This clot will be compressed into a membrane between two sterile gauzes moistened with saline, with as little finger pressure as possible. The shaped PRF will be placed to cover the entire diabetic foot wound under sterile conditions. Then the dressing will be closed by covering with sterile gauze.These applications will be repeated weekly and applied for a total of 11 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •1st or 2nd degree diabetic foot wound according to Wagner classification
- •Absence of infection in diabetic foot wound
- •Being over 18 years old
- •Willingness to participate in the research
- •Absence of any allergic disease
- •Absence of bleeding disorder
- •Not receiving corticosteroid treatment
- •Not using anticoagulant medication
- •Not smoking
- •Absence of circulatory disorders in the lower extremities
- •HbA1c value below 12% (Mean blood glucose value 298 mg/dL) in the most recent examination
排除标准
- •3rd, 4th and 5th degree diabetic foot wound according to Wagner classification
- •Presence of infection in diabetic foot wound
- •Being under the age of 18
- •Not being willing to participate in the research
- •Presence of any allergic disease
- •Having a bleeding disorder
- •Being on corticosteroid treatment
- •Using anticoagulant medication
- •HbA1c value above 12% (average blood glucose value 298 mg/dL) in the most recent examination
- •Having circulatory disorders in the lower extremities
结局指标
主要结局
Wound Observation and Evaluation Form
时间窗: Healing on diabetic foot wounds at 12 weeks.
The length, width, depth, exudate, necrotic tissue, wound bed, skin around the wound, etc. aspects will be evaluated with this form.
次要结局
未报告次要终点
研究者
Ebru ÇELEBİ
Lecturer
Abant Izzet Baysal University