EUCTR2018-003596-36-GB进行中（未招募）1 期
A single centre, open label Randomised Controlled Trial of the RAPID™* PRP (Platelet Rich Plasma) Haematogel Wound Care Treatment in addition to Usual and Customary Care, (UCC); compared to Usual and Customary Care (UCC) alone, in the management of adult patients with chronic Diabetic Foot Ulcers. RAPID™* [Restorative Autologous Platelet biotherapies for treatment of Injuries & Delayed wound healing] Biodynamic Platelet Rich Plasma [PRP] Haematogel - RAPID-1 Diabetic Foot Ulcer Study [Version 2.0]
Biotherapy Services Ltd.0 个研究点目标入组 66 人开始时间: 2019年6月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patients will be eligible for this study if they meet the following inclusion criteria:
- •1.Ability to give written informed consent
- •2. Male or female with confirmed type 1 or type 2 diabetes.
- •3.Age 18-90 years.
- •4.Diabetic foot ulcer (DFU) measuring more than 0.5cm x 0.5cm and lesser than 10cm x 10cm, present for more than 12 weeks.
- •5.Only one ulcer present on the affected limb.
- •6.Patient understands and is willing to participate and can comply with the follow-up regime.
- •7.Patient understands and is willing to participate in full UCC, including recommended off-loading strategy
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •Patient will be consdiered inelgible if they have any of the following:
- •1. Wound with active infection which simple debridement cannot eradicate; any post-debridement remaining underlying osteomyelitis
- •2.Patients with underlying vascular insufficiency (If ABPI<0.9 or ABPI>1.3, duplex or other arterial imaging will be required to demonstrate in-line flow into the foot).
- •3.Uncontrolled Diabetes Mellitus, as measured by an HbA1c > 10%. (86mmol/mol)
- •4.Hb<10.5g/dl
- •5.One or more of the following medical comorbidities - hepatic, hematologic, active auto-immune or immune diseases.
- •6.Patient with known or suspected current malignancy.
- •7.Patient not fit for surgery (ASA classification > 4)
- •8.Poor venous access.
- •9. Critical thrombocytopenia
- •10. Septicemia
- •11. Platelet count of<100/ul
- •12. Serum albumin of <2.5g/dL
- •13. Pregnancy
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