EUCTR2009-011755-47-DE进行中（未招募）不适用
A feasibility study to evaluate the effect of Vivostat® Platelet Rich Fibrin (PRF®) in the treatment of diabetic foot ulcers - PRF Diabetic Foot Study
Vivostat A/S0 个研究点目标入组 60 人开始时间: 2009年4月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- 性别
- All
入选标准
- •1.Age: >18 years
- •2.Type I or Type II Diabetes Mellitus
- •3.Ulcer(s) at or below the ankle which have been present for at least 4 weeks, and have received best practice care
- •4.Ulcer area between 0,5 and 16 cm2 after sharp debridement
- •5.If there is more than one ulcer the investigator shall choose one index ulcer to be treated (typically the largest one). The other ulcers will receive standard care and are not to be included in the study. A maximum of 2 ulcers is allowed at the foot investi-gated
- •6.Ulcer type: University of Texas grade IA.
- •7.Evidence of adequate arterial perfusion: Toe pressure reading of = 30 mmHg or if toe is missing, transcutaneous oxygen (TcPO2) of = 30mmHg on the foot.
- •8.Patient foot is appropriately off loaded (contact cast, pneumatic walking cast)
- •9.Orthopaedic assessment has been completed to rule out a mechanical source of ulcera-tion
- •10.Relative wound area reduction less than 50% from week –3 to week 0 (pre-screening period)
- •11.Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Clear indication for surgery (vascular reconstruction or skin transplant)
- •2.Ulcer with exposed bone or tendon
- •3.Bone involvement (probe to bone or x-ray)
- •4.Patients with 3 ulcers or more on at the foot investigated
- •5.Osteomyelitis
- •6.Clinical signs of infections in the ulcer studied
- •7.Patients with Necrosis in the ulcer that cannot be removed by debridement at Week 0
- •8.Patients with known Methicillin-resistant Staphylococcus aureus (MRSA) in the specific ulcer treated in the study
- •9.Malnutrition. Albumin < 2,5g/dl
- •10.Ulcers resulting from electrical, chemical, radiation burns
- •11.HbA1c > 12%
- •12.Male : Hb < 8 g/dl Female : Hb < 7 g/dl
- •13.Platelet count <140 *109/l
- •14.Pregnancy and fertile women not practising sufficient birth control
- •15. Fertile women with a positive pregnancy test week 0
- •16.Lactating women
- •17.Patients on haemodialysis
- •18.Limb ischemia requiring re-vascularisation or impending amputation
- •19.History of peripheral vascular repair within 4 weeks prior to randomization
- •20.Bleeding disorders, haemophilia, sickle cell disease, thrombocytopenia, and leukaemia or blood dyscrasias
- •21.Current treatment for malignancy or neoplastic disease or collagen scular disease
- •22.Patient has a highly communicable disease or diseases that may limit follow
- •23.Patients with immuno-compromised conditions, hepatitis, active tuberculosis
- •24.Patient has inadequate venous access to draw blood
- •25.History of alcohol or drug abuse within the last year prior to randomization
- •26.Patient known to have psychological, developmental, physical, emotional or social dis-order or other ailments that may interfere with the study requirements
- •27.Patients enrolled in an other clinical trial for wound treatment within 30 days prior to enrolment
- •28.Non-compliance in the screening period
- •29.Patients who have received growth factor therapy e.g. becaplermin within 7 days prior to enrolment
- •30.Relative wound area reduction greater than 50% from Week-3 to Week 0 (Run-in)
研究者
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