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The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)

2011年12月1日 更新者：Pfizer

A 6 Month, Prospective, Open-Label Multiple Center Extension Trial To Evaluate The Long Term Safety And Sustained Efficacy Of Fragmin In The Treatment Of Chronic Foot Ulcers In Diabetic Patients With Peripheral Arterial Occlusive Disease

The primary objective of this 6 month open-label extension trial is to evaluate long-term safety and tolerability of dalteparin in treatment of chronic neuroischaemic foot ulcers in diabetic patients with peripheral arterial occlusive disease (PAOD) and peripheral neuropathy.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

62

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 丹麦
      • Aarhus C、丹麦、8000
        • Pfizer Investigational Site
  • 乌克兰
      • Kharkiv、乌克兰、61002
        • Pfizer Investigational Site
      • Kyiv、乌克兰、02091
        • Pfizer Investigational Site
      • Lviv、乌克兰、79010
        • Pfizer Investigational Site
  • 俄罗斯联邦
      • Moscow、俄罗斯联邦、123423
        • Pfizer Investigational Site
      • Moscow、俄罗斯联邦、127486
        • Pfizer Investigational Site
      • Saint-Petersburg、俄罗斯联邦、194156
        • Pfizer Investigational Site
    • Russia
      • Moscow、Russia、俄罗斯联邦、119034
        • Pfizer Investigational Site
  • 加拿大
    • Manitoba
      • Winnipeg、Manitoba、加拿大、R3A 1R9
        • Pfizer Investigational Site
  • 奥地利
      • Wien、奥地利、A-1090
        • Pfizer Investigational Site
  • 希腊
      • Melissia/Athens、希腊、15127
        • Pfizer Investigational Site
  • 德国
      • Karlsbad、德国、76307
        • Pfizer Investigational Site
  • 意大利
      • Firenze、意大利、50139
        • Pfizer Investigational Site
  • 挪威
      • Tonsberg、挪威、3103
        • Pfizer Investigational Site
  • 捷克共和国
      • Praha 5、捷克共和国、150 06
        • Pfizer Investigational Site
      • Zlin、捷克共和国、760 01
        • Pfizer Investigational Site
  • 比利时
      • Ransart、比利时、6043
        • Pfizer Investigational Site
  • 波兰
      • Lodz、波兰、90-153
        • Pfizer Investigational Site
      • Pulawy、波兰、24-100
        • Pfizer Investigational Site
      • Warszawa、波兰、02-097
        • Pfizer Investigational Site
      • Wroclaw、波兰、51-124
        • Pfizer Investigational Site
  • 瑞典
      • Karlstad、瑞典、651 85
        • Pfizer Investigational Site
      • Malmo、瑞典、205 02
        • Pfizer Investigational Site
      • Stockholm、瑞典、118 83
        • Pfizer Investigational Site
      • Stockholm、瑞典、171 76
        • Pfizer Investigational Site
      • Stockholm、瑞典、182 88
        • Pfizer Investigational Site
  • 英国
      • Birmingham、英国、B9 5SS
        • Pfizer Investigational Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Subjects must have completed the 6 month study duration in the A6301083 study.
  • Subjects must have a positive ulcer treatment response, defined as a reduction in the study ulcer area size (ie, ulcer area reduction >0%) at Visit 8 (EOT Visit) from baseline in the A6301083 study.
  • All ulcers must have an ulcer staging of 1C, 2C, 1D or 2D according to the University of Texas wound classification system

Exclusion Criteria:

  • Subjects who have the following:
  • Intact skin healing (defined as 100% reduction in ulcer surface area with full epithelialisation at or prior to the EOT visit in the A6301083 study).
  • A study ulcer area at Visit 8 (EOT visit) which is greater or equal to the baseline ulcer area (ie, ulcer area increase ≥0%) in the A6301083 study.
  • Subjects with an ulcer grading of 0 or 3 or staging of A or B according to the University of Texas wound classification system.
  • Subjects with a known bleeding disorder or evidence of active bleeding.
  • Subjects who are on dialysis.
  • Subjects who where found to be major protocol violators in A6301083 study.
  • Subjects who did not complete the 6 month study period of the A6301083 study

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：积极的
积极的研究治疗
药品：Fragmin
Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium
其他名称：
  • 达肝素钠

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of All Hemorrhages
大体时间：Baseline to Week 24 (end of treatment [EOT]) or early termination (ET)
Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of greater than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.
Baseline to Week 24 (end of treatment [EOT]) or early termination (ET)
Number of Major Hemorrhages
大体时间：Baseline to Week 24 (EOT) or ET
Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 g/L (2 g/dL), clinically overt bleeding leading to transfusion of greater than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular).
Baseline to Week 24 (EOT) or ET
Number of Minor Hemorrhages
大体时间：Baseline to Week 24 (EOT) or ET
Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.
Baseline to Week 24 (EOT) or ET
Number of Clinically Relevant Minor Hemorrhages
大体时间：Baseline to Week 24 (EOT) or ET
Clinically relevant minor (non-major) bleeding was defined as any bleeding compromising hemodynamics, leading to hospitalization, subcutaneous haematoma more than 25 cm^2, intramuscular haematoma, epistaxis lasting for more than 5 minutes, spontaneous gingival bleeding, macroscopic hematuria and gastrointestinal hemorrhage (including at least 1 episode of melaena or hematemesis), rectal blood loss, hemoptysis, and any other bleeding with clinical consequences.
Baseline to Week 24 (EOT) or ET
Number of Trivial Hemorrhages
大体时间：Baseline to Week 24 (EOT) or ET
Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.
Baseline to Week 24 (EOT) or ET

次要结果测量

结果测量
措施说明
大体时间
Number of Participants With Intact Skin Healing
大体时间：Baseline through Week 24 (EOT) or ET
Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. The ulcer area was measured in square millimetre (mm) by measuring the longest width and length of the ulcer after debridement. The area was calculated from an acetate tracing. Ulcers were also documented by standardized photographs. The largest ulcer was considered the study ulcer in participants with multiple ulcers.
Baseline through Week 24 (EOT) or ET
Number of Participants With Improved Ulcer Healing
大体时间：Baseline through Week 24 (EOT) or ET
Improved ulcer healing was defined as greater than or equal to 50 percent reduction in ulcer surface area from baseline of the A6301083 study excluding intact skin healing. The ulcer area was measured in square mm by measuring the longest width and length of the ulcer after debridement. Ulcers were also documented by standardized photographs.
Baseline through Week 24 (EOT) or ET
Number of Participants Who Underwent Amputation
大体时间：Baseline through Week 24 (EOT) or ET
A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation.
Baseline through Week 24 (EOT) or ET
Time to Intact Skin Healing
大体时间：Baseline through Week 24 (EOT) or ET
Median time (in months) taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.
Baseline through Week 24 (EOT) or ET
Time to First Amputation
大体时间：Baseline through Week 24 (EOT) or ET
Baseline through Week 24 (EOT) or ET
Number of Participants With Major Cardiovascular Disease Events (MCVE)
大体时间：Baseline through Week 24 (EOT) or ET
MCVE were defined as death due to vascular cause; non-fatal myocardial infarction (MI) excluding procedure related to MI; coronary revascularization procedures not related to MIs; hospitalization for unstable angina or non-fatal stroke.
Baseline through Week 24 (EOT) or ET
11-point Likert Pain Scale
大体时间：Baseline and Week 24 (EOT) or ET
The 11 point Likert pain scale which used a 0 (no pain) to 10 (worst possible pain) point rating system was used to assess participant's pain score. No distinction was made between neuropathy and inflammatory (nociceptive) pain.
Baseline and Week 24 (EOT) or ET
36-Item Short-Form Health Survey (SF-36) Score
大体时间：Baseline and Week 24 (EOT) or ET
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Baseline and Week 24 (EOT) or ET

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Pfizer

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年10月1日

初级完成 (实际的)

2010年10月1日

研究完成 (实际的)

2010年10月1日

研究注册日期

首次提交

2008年9月30日

首先提交符合 QC 标准的

2008年9月30日

首次发布 (估计)

2008年10月2日

研究记录更新

最后更新发布 (估计)

2012年1月13日

上次提交的符合 QC 标准的更新

2011年12月1日

最后验证

2011年12月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • A6301086

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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