The Effect of Combination Therapy of Oral Methylene Blue and Platelet-rich Plasma-fibrin Glue in Patients With Non-healing Diabetic Foot Ulcer: a Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Wound Size
研究概览
简要总结
The aim of this study is to evaluate the chance of non-healing diabetic foot ulcers repair by improving the condition of lack of oxygen or hypoxia in the wound area caused by diabetes using methylene blue along with the use of platelet-rich plasma-fibrin glue as an effective treatment for wound healing.
详细描述
The current study assesses the effects of methylene blue along with the use of platelet-rich plasma-fibrin glue on wound healing in patients with nonhealing diabetic foot ulcers (non-healing DFU). This randomized controlled trial is performed on 20 patients with non-healing DFU. Patients were treated with PRP-FG dressing plus 200 ml of oral methylene blue dissolved in milk(intervention group) or PRP-FG dressing plus placebo (200 ml of milk) (control group) for 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having a Diabetic ulcer grade II and IV based on Wagner's classification on the sole, medial, or lateral part of the foot (including all surfaces of the toes)
- •Having a single ulcer on the feet and extremities (toes, soles, heels) with no significant reduction in ulcer size (<20%) despite the use of best treatment methods for at least four weeks
- •If there is more than one non-healing wound, choose the largest wound
- •The size of the wound surface (length × width) between 2 cm2 and 20 cm2
- •No smoking, alcohol, and drug addiction based on the patient's self-report
- •Not taking drugs that may interfere with wound healing, such as Corticosteroids, immunosuppressants, and cytotoxic agents
- •Not having a concurrent chronic disease that may cause problems in wound healing, such as cancers, vasculitis, no history of known severe kidney, liver, and heart disease, such as liver cirrhosis, active hepatitis, dialysis, etc.
- •Not taking antidepressants
- •Insensitivity to milk lactose
- •Not having Glucose 6-phosphate dehydrogenase (G6PD) deficiency
- •Confirmed, informed, signed consent form
- •Ankle Brachial Index (ABI) higher than or equal to 0.7
排除标准
- •Do not be treated with methylene blue
- •The confirmed presence of osteomyelitis, or if there is suspicion of osteomyelitis
- •The subject is pregnant or intends to become pregnant during the test period
- •The patient is known to have mental, developmental, physical, and emotional disorders
- •The occurrence of certain medical conditions
- •The presence of a wound with a clear and severe infection, which is characterized by significant purulent secretions or extensive cellulitis, or gangrene requiring amputation
- •Evidence of venous, ischemic, neurotrophic ulcers (numbness, tingling, lack of Achilles tendon reflex) and traumatic wounds in the patient
- •Failure to refer the patient more than two times to the mentioned center for follow-up and dressing change
- •Hypersensitivity reaction to methylene blue
- •Platelet count less than 100,000
- •The patient's lack of consent to continue cooperation
研究组 & 干预措施
Methylene Blue and Platelet-Rich Plasma-Fibrin Glue
Patients with non-healing Diabetic Foot Ulcers will treat with PRP-Fibrin-Glue plus oral methylene blue (70 mg in 200 ml of milk) for 4 weeks.
干预措施: Methylene Blue and Platelet-Rich Plasma-Fibrin Glue (Drug)
Methylene Blue
The first intervention group (group A) includes diabetic patients with chronic foot ulcers who, despite common treatments, will be undergone oral methylene blue intervention (70 mg in 200 ml of milk) for 4 weeks.
干预措施: Methylene Blue (Drug)
Milk (control)
Patients with non-healing Diabetic Foot Ulcers only will receive 200 ml of milk for 4 weeks.
干预措施: Milk (control) (Other)
Milk and Platelet-Rich Plasma-Fibrin Glue (control)
Patients with non-healing Diabetic Foot Ulcers will be treated with PRP-Fibrin-Glue and 200 ml of milk for 4 weeks.
干预措施: Milk and Platelet-Rich Plasma-Fibrin Glue (control) (Other)
结局指标
主要结局
Wound Size
时间窗: 4 weeks
Wound size will be measured with a ruler for length, and width as well as with digital imaging. Wound size will be assessed in digital images taken of the wound.
The healing rate of the ulcer
时间窗: 4 weeks
Measurement of wound area with a ruler
次要结局
- Platelet count at baseline and after the intervention(4 weeks)
- Blood pressure (systolic and diastolic)(4 weeks)
- Serum IL-6 levels at baseline and after the intervention(4 weeks)
- Serum FBS levels at baseline and after the intervention(4 weeks)
- Serum Insulin levels at baseline and after the intervention(4 weeks)
- Lipid Profile at baseline and after the intervention(4 weeks)
- Serum Creatinine at baseline and after the intervention(4 weeks)
- Serum total bilirubin at baseline and after the intervention(4 weeks)
- HbA1c at baseline and after the intervention(4 weeks)
- Uric Acid levels at baseline and after the intervention(4 weeks)
- Serum Homocysteine levels at baseline and after the intervention(4 weeks)
- TcPO2 at baseline and after the intervention(4 weeks)
- Oxygen saturation at baseline and after the intervention(4 weeks)
- Serum TNF-α levels at baseline and after the intervention(4 weeks)
- Serum Vitamin D levels at baseline and after the intervention(4 weeks)
- Serum AST (Aspartate Transferase) levels at baseline and after the intervention(4 weeks)
- Serum ALP (alkaline phosphatase) levels at baseline and after the intervention(4 weeks)
- Nitric oxide blood at baseline and after the intervention(4 weeks)
- Serum lactate dehydrogenase (LDH) levels at baseline and after the intervention(4 weeks)
- The resting systolic toe pressure (TP) at baseline and after the intervention(4 weeks)
- Serum IL-1β levels at baseline and after the intervention(4 weeks)
- Serum MCP-1 levels at baseline and after the intervention(4 weeks)
- Serum Met Hemoglobin levels at baseline and after the intervention(4 weeks)
- Serum Hemoglobin (Hgb, Hb) levels at baseline and after the intervention(4 weeks)
- Serum white blood cells (WBCs) levels at baseline and after the intervention(4 weeks)
- Serum Erythrocyte Sedimentation Rate (ESR) levels at baseline and after the intervention(4 weeks)
- Serum HIF-1α levels at baseline and after the intervention(4 weeks)
- Serum Urea at baseline and after the intervention(4 weeks)
- Serum Albumin (Alb) levels at baseline and after the intervention(4 weeks)
- Serum ALT (alanine transaminase) levels at baseline and after the intervention(4 weeks)
- Serum total Lymphocyte levels at baseline and after the intervention(4 weeks)
- Neutrophils count at baseline and after the intervention(4 weeks)
- Serum C-Reactive Protein (CRP) levels at baseline and after the intervention(4 weeks)
研究者
Daryoush Hamidi Alamdari, PhD
Associate professor
Mashhad University of Medical Sciences