NCT00770939已完成4 期
A Cohort Study to Evaluate the Effect of Vivostat Platelet Rich Fibrin on Diabetic Foot Ulcers.
Vivostat7 个研究点 分布在 3 个国家目标入组 60 人开始时间: 2008年7月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- Proportion of completely healed ulcers after 12 weeks
研究概览
简要总结
Diabetic foot ulcers are a challenge to health care professionals because there are only few effective topical therapeutic interventions.
Growth factor treatment has shown to be beneficial for healing of diabetic foot ulcers in conjunction with extensive surgical debridement. Autologues platelet releasate which contains platelet derived growth factor appears to be more effective than standard therapy in case studies.
This protocol will evaluate the healing effect of Vivostat PRF treatment of non-eschemic foot ulcers to identify responders and to enable sample size calculation for a subsequent pivotal trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 4 weeks history (with wound area measurements) within a wound care institution before the first visit (week -3). In case of referral the patient history must be documented
- •All patients must complete a 3 week screening period i.e. they will be interviewed and accessed at the first meeting. During the 3 week period patient compliance will be monitored.
- •Age >18 years
- •Type I or Type II Diabetes Mellitus
- •Ulcer at or below the ankle which has been present for at least 4 weeks, and has received best practice care
- •Ulcer area between 0,5 and 16 cm2
- •If there is more than one ulcer or bilateral ulcers, the investigator shall choose the one index ulcer to be treated (typically the largest one). The other ulcers will receive standard care and is not included in the study
- •Ulcer type: University of Texas grade IA.
- •Evidence of adequate arterial perfusion: Toe pressure reading of ≥ 30 mmHg or if toe is missing, transcutaneous oxygen (TcPO2) of ≥ 30mmHg on the foot.
- •Patient foot is appropriately off loaded (contact cast, pneumatic walking cast)
- •Orthopaedic assessment has been completed to rule out a mechanical source of ulceration
- •Relative wound area reduction less than 50% from week -3 to week 0 (pre-screening period)
- •Signed informed consent
排除标准
- •Clear indication for surgery (vascular reconstruction or skin transplant)
- •Ulcer with exposed bone or tendon
- •Bone involvement (probe to bone or x-ray)
- •Patients with 3 ulcers or more at the foot investigated
- •Osteomyelitis
- •Clinical signs of infections
- •Necrosis in the wound (one week into the screening period).
- •Patients with known MRSA
- •Malnutrition. Albumin < 2,5g/dl
- •Ulcers resulting from electrical, chemical, radiation burns
- •HbA1c > 12%
- •Male: Hb < 8 mmol/l (12,9 g/dlFemale: Hb < 7 mmol/l (11,3 g/dl)
- •Platelet count <140 *109/l
- •Pregnancy and fertile women not practicing sufficient birth control
- •Fertile women having a positive pregnancy test week 0 Lactating women
- •Patients on haemodialysis
- •History of peripheral vascular repair within 4 weeks prior to study enrollment
- •Bleeding disorders, haemophilia, sickle cell disease, thrombocytopenia, and leukaemia or blood dyscrasias
- •Current treatment for malignancy or neoplastic disease or collagen vascular disease
- •Highly communicable disease or diseases that may limit follow - up (e.g. immunocompromised conditions, hepatitis, active tuberculosis)
- •Patient has inadequate venous access to draw blood
- •History of alcohol or drug abuse within the last year prior to randomization
- •Patient known to have psychological, developmental, physical, emotional or social dis-order or other ailments that may interfere with the study requirements
- •Patients enrolled in an other clinical trial for wound treatment within 30 days prior to enrollment
- •Non-compliance in the screening period
- •Patients who have received growth factor therapy e.g. becaplermin within 7 days prior to enrollment
结局指标
主要结局
Proportion of completely healed ulcers after 12 weeks
时间窗: 12 weeks
Percentage of patients with a 50% reduction of wound area after 4 and 8 weeks
时间窗: 8 weeks
次要结局
- Granulation rate(12 weeks)
研究者
研究点 (7)
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