A Randomized, Double-Blind, Parallel-group, Clinical Trial to Evaluate the Effect of Platelet-Rich Plasma-Fibrin Glue in Combination With Vitamin E and C for Treatment of Non-healing Diabetic Foot Ulcers
试验速览
- 阶段
- 2 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Healing rate of the ulcer
研究概览
简要总结
The aim of this study is to evaluates the chance of non-healing Diabetic Foot Ulcers repair by reducing oxidative stress caused by diabetes by taking vitamin E and C supplements along with the use of Platelet-Rich Plasma-Fibrin Glue as an effective treatment for wound healing.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DFU is classified as Wagner 1 -2 on the Wagner classification system.
- •Persons with type 1 or type 2 diabetes with a non-healing ulcer of at least 4 weeks duration.
- •If more than one non-healing wound is present, the largest of the wounds that is classified as a Wagner 1-
- •The index ulcer had to be clinically non-infected.
- •Ankle Brachial Index (ABI) greater than or equal to 0.
- •HemoglobinA1C (HbA1c) < 12
- •Index foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces).
- •Wound area (length x width) measurement between 2 cm2 and 20 cm
- •Non-use of drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents.
- •No smoking, alcohol or drug addiction.
- •Approved, informed, signed consent.
排除标准
- •Previous consumption of vitamin E and C supplements.
- •Index ulcer has exposed tendons, ligaments, muscle, or bone.
- •Confirmed presence of osteomyelitis, or if osteomyelitis is suspected.
- •Patients with renal deficiency, hepatic failure, has known immune insufficiency and cancer.
- •Subject is pregnant or plans to become pregnant during the duration of the trial.
- •Patient's blood vessels are non-compressible for ABI testing.
- •Patient is known to have a psychological, developmental, physical, emotional disorders.
- •Received systemic corticosteroids or immunosuppressive agents.
研究组 & 干预措施
Intervention group
Patients with non-healing Diabetic Foot Ulcers treated with PRP-Fibrin-Glue plus vitamin supplements (E (200 IU/ 2day) and C (250 mg/ 2day) ) for 8 weeks.
干预措施: PRP-Fibrin Glue (Drug)
Intervention group
Patients with non-healing Diabetic Foot Ulcers treated with PRP-Fibrin-Glue plus vitamin supplements (E (200 IU/ 2day) and C (250 mg/ 2day) ) for 8 weeks.
干预措施: Vitamin E and C (Dietary Supplement)
Control group
Patients with non-healing Diabetic Foot Ulcers treated with PRP-Fibrin-Glue plus placebo for 8 weeks.
干预措施: PRP-Fibrin Glue (Drug)
Control group
Patients with non-healing Diabetic Foot Ulcers treated with PRP-Fibrin-Glue plus placebo for 8 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Healing rate of the ulcer
时间窗: 2 months
Examination by a vascular surgery physician and documentation
Wound Size
时间窗: 2 months
Wound size will be measured with ruler for length, width as well as with digital imaging. Wound size will be assessed in digital images taken of the wound.
次要结局
- Serum ESR at baseline and after the intervention(2 months)
- Serum hs-CRP at baseline and after the intervention(2 months)
- HbA1c at baseline and after the intervention(2 months)
- Serum Urea at baseline and after the intervention(2 months)
- Serum total bilirubin at baseline and after the intervention(2 months)
- Serum Uric acid at baseline and after the intervention(2 months)
- FBS at baseline and after the intervention(2 months)
- Lipid Profile at baseline and after the intervention(2 months)
- Serum Creatinine at baseline and after the intervention(2 months)
- Serum Homocysteine at baseline and after the intervention(2 months)
- Pro-Oxidant Antioxidant Balance at baseline and after the intervention(2 months)
研究者
Daryoush Hamidi Alamdari
Associate professor
Mashhad University of Medical Sciences