Allogeneic Defibrinated Platelet Rich Plasma Lysate for the Healing of Chronic Diabetic Foot Ulcer
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the injection
研究概览
简要总结
Allogenic defibrinated platelet rich plasma lysate will be injected in patients diagnosed with Diabetic Foot Ulcer (DFU).
详细描述
In this study, allogenic, defibrinated platelet rich plasma lysate will be used as a direct injection into the periphery of diabetic chronic foot ulcers which have not healed using standard of care. Investigators anticipate a significant response in treated individuals measured by the percentage of skin restoration achieved.
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 (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons with type 1 or type 2 diabetes between the ages of 18 and 70 with an ulcer of at least 4 weeks duration
- •HemoglobinA1C (HbA1c) < 12
- •Index foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces); and wound area (length x width) measurement between 2 cm2 and 20 cm2, inclusive.
- •Wounds located under a Charcot deformity had to be free of acute changes and must have under gone appropriate structural consolidation.
- •The index ulcer had to be clinically non-infected and full - thickness without exposure of bone, ligaments, or tendons.
- •The protocol requires that post debridement the ulcer would be free of necrotic debris, foreign bodies or sinus tracts.
- •Non- invasive vascular testing ankle brachial index (ABI).
- •Physical examination (including a Semmes-Weinstein monofilament test for neuropathy)
- •Blood tests to be obtained Complete Blood Count and HbA1c.
- •Approved, informed, signed consent.
- •Negative test for Hepatitis C (HC), Hepatitis B (HB), Human Immunodeficiency Virus 1 and 2 (HIVI and II), Venereal Disease Research Laboratory (VDRL).
排除标准
- •Patient currently enrolled in another investigational device or drug trial or previously enrolled (within last 30 days) in investigative research of a device or pharmaceutical agent.
- •Ulcer decreased ≥50% in area during 7-day screening period.
- •Ulcer is due to non-diabetic etiology.
- •Patient's blood vessels are non-compressible for ABI testing.
- •Evidence of gangrene in ulcer or on any part of the foot.
- •Patient has radiographic evidence consistent with diagnosis of acute Charcot foot.
- •Patient is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
- •Patient has received growth factor therapy within 7 days of randomization.
- •Screening hemoglobin <10.5 mg/dL.
- •Screening platelet count < 100 x 109/L.
- •Patient is undergoing renal dialysis, has known immune insufficiency, known abnormal platelet activation disorders - ie, gray platelet syndrome, liver disease, active cancer (except remote basal cell of the skin), eating/ nutritional,hematologic, collagen vascular disease, rheumatic disease, or bleeding disorders.
- •History of peripheral vascular repair within the 30 days of randomization
- •Patient has known or suspected osteomyelitis.
- •Surgical correction (other than debridement) required for ulcer to heal.
- •Index ulcer has exposed tendons, ligaments, muscle, or bone.
- •Patient is known to have a psychological, developmental, physical, emotional, or social disorder, or any other situation that may interfere with compliance with study requirements and/or healing of the ulcer
- •History of alcohol or drug abuse within the last year prior to randomization.
- •Patient has inadequate venous access for blood draw.
- •Positive test for HC, HB, HIVI and II, VDRL.
研究组 & 干预措施
Platelet Lysate
Patients will receive 5ml peri-lesional injections of Platelet Lysate at weekly intervals, for 4 consecutive times (week 0,1,2,3).
干预措施: Platelet Lysate (Biological)
Platelet Poor Plasma
Patients will receive 5ml peri-lesional injections of Platelet Poor Plasma at weekly intervals, for 4 consecutive times (week 0,1,2,3).
干预措施: Platelet Poor Plasma (Biological)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the injection
时间窗: 3 months
Evaluate the safety of this treatment, by gathering and assessing the number, timing, severity, duration, and resolution of related adverse events.
次要结局
- Assess the efficacy of allogenic Platelet Lysate injection by clinical examination(4 months)
研究者
Hanan Jafar
Researcher
University of Jordan