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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Number of All Hemorrhages
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •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
排除标准
- •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
研究组 & 干预措施
Active
Active study treatment
干预措施: Fragmin (Drug)
结局指标
主要结局
Number of All Hemorrhages
时间窗: 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.
Number of Major Hemorrhages
时间窗: 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).
Number of Minor Hemorrhages
时间窗: Baseline to Week 24 (EOT) or ET
Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.
Number of Clinically Relevant Minor Hemorrhages
时间窗: 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.
Number of Trivial Hemorrhages
时间窗: 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.
次要结局
- Time to First Amputation(Baseline through Week 24 (EOT) or ET)
- Number of Participants With Intact Skin Healing(Baseline through Week 24 (EOT) or ET)
- Number of Participants With Improved Ulcer Healing(Baseline through Week 24 (EOT) or ET)
- Number of Participants Who Underwent Amputation(Baseline through Week 24 (EOT) or ET)
- Time to Intact Skin Healing(Baseline through Week 24 (EOT) or ET)
- Number of Participants With Major Cardiovascular Disease Events (MCVE)(Baseline through Week 24 (EOT) or ET)
- 11-point Likert Pain Scale(Baseline and Week 24 (EOT) or ET)
- 36-Item Short-Form Health Survey (SF-36) Score(Baseline and Week 24 (EOT) or ET)