Autologous Intra-lesional Injection of Resticutis Compared to Platelet-Poor Plasma to Improve Healing of Wagner's Grade II/III Diabetic Foot Ulcers (Neuropathic/Neuro-Iscemic)
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 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
The purpose of this study is to determine the safety of Resticutis for the treatment of Wagner's Grade II/III diabetic foot ulcers in comparison with Platelet-Poor Plasma as a placebo comparator.
详细描述
Grade II and III (According to Wagner's classification system of Ulcer severity) are considered to be of the most common complications associated with Diabetes, which are mostly hard to heal using the conventional treatment methods which by consequence severely affects the quality and lifestyle of the diabetes patient.
It's thought that the application of Autologous activated platelets "Resticutis" which secretes huge amounts of growth factors is capable of giving better results of which are: the stimulation of the healing process that includes contraction, granulation, tissue formation and epithelialization of the diabetic foot ulcer.
Resticutis is obtained from an autologous 20 mL peripheral blood withdrawn in tubes containing 3.8% Sodium Citrate. Blood is then centrifuged to obtain Platelet-Rich Plasma -PRP- as per established method. PRP is then activated in a closed system by physical methods to obtain a final product of 5 mL of Resticutis which is injected intra-lesionally at ulcer margins per each session of therapy.
It's hypothesized that a total of six injections throughout the period of the treatment are enough to achieve full closure of the DFU. The injections are given on days: 0,14,28,42,56, and 70 of the treatment period.
The consenting patients will be randomized into 2 groups: One group will be given Resticutis, and the second one Platelet-Poor Plasma PPP as placebo. If patients in PPP group didn't achieve full healing after four-six injections, they're given a two weeks rest after which they are given Resticutis instead.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •People with Type II Diabetes mellitus between the ages of 18 and 70 with an ulcer with at least 4 weeks duration.
- •Hb1c of less than 13 %.
- •Index foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces), and wound area (length*width) measurement between 0.5 cm^2 and 20 cm^2, inclusive.
- •Wounds located under a Charcot deformity has to be free of acute changes and went through appropriate structural consolidation.
- •Wagner Grade II or III ulcer.
- •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 (CBC, Hb1c)
- •Approved, informed, signed consent to be obtained from each patient.
排除标准
- •Patient currently enrolled in another investigative device or drug trial or previously enrolled (within the last 30 days) in an investigative research of a device or a pharmaceutical agent.
- •Ulcer area decreased > 50% during the seven-day screening period.
- •Ulcer is due to a non-diabetic etiology.
- •Evidence of gangrene in ulcer or on any part of the foot.
- •Patient is currently receiving or has received radiation or chemotherapy within the last 3 months of randomization.
- •Patient has received growth factor therapy within 7 days of randomization.
- •Screening platelets count < 100* 10^9/L.
- •Patient is undergoing renal dialysis, or has a known immune insufficiency, known abnormal platelets activation disorder (i.e. Grey Platelet Syndrome, Liver Disease, Active Cancer), eating/nutritional, hematologic, collagen vascular disease, rheumatic disease, or bleeding disorder.
- •History of peripheral vascular repair within 30 days of randomization.
- •Patient is known to have a physiological, developmental, physical, emotional, or social disorder, or any other situation that may interfere with their compliance with the study requirements and/or the healing of the ulcer.
- •History of alcohol or drug abuse within the last year prior to randomization.
- •Patient has inadequate venous access for blood withdraw.
研究组 & 干预措施
A-Resticutis
Autologous, Activated-Platelets type of preparation.
干预措施: Resticutis (Other)
C-Platelet-Poor Plasma PPP
Platelet-Poor Plasma type of preparation achieved by centrifugation of blood samples at high speed conditions. Resticutis is administered instead if the patient doesn't achieve full healing after 6 injections.
干预措施: Resticutis (Other)
C-Platelet-Poor Plasma PPP
Platelet-Poor Plasma type of preparation achieved by centrifugation of blood samples at high speed conditions. Resticutis is administered instead if the patient doesn't achieve full healing after 6 injections.
干预措施: Platelet-Poor Plasma (PPP) (Other)
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: 2 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 autologous Resticutis injection by clinical examination(4 months)
研究者
Hanan Jafar
Researcher
University of Jordan