A 6 Month, Prospective, Randomized, Double Blind, Placebo-Controlled, Parallel Group, Multiple Center Trial To Evaluate The Efficacy And Safety Of Fragmin In The Treatment Of Chronic Neuroischaemic Foot Ulcers In Diabetic Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing
研究概览
简要总结
The purpose of the study isto see the effect of Fragmin on the healing of diabetic foot ulcers by determining the number of subjects with ≥50% reduction in ulcer surface area including intact skin healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Male or female subjects 18 years of age with type 1 or type 2 diabetes.
- •Subjects with peripheral occlusive arterial disease (PAOD) and a neuropathy disability score (NDS) of >3
排除标准
- •Subjects who have undergone vascular reconstruction or angioplasty less than 1 month prior to randomization. Subjects with an ulcer grading of 0 or 3 and staging of A, B or D according to the University of Texas wound classification system.
- •Subjects with a known bleeding disorder or evidence of active bleeding.
研究组 & 干预措施
Active
Active study treatment
干预措施: Fragmin/ Dalteparin Sodium (Drug)
Placebo
Placebo
干预措施: Placebo for Fragmin/ Dalteparin Sodium (Drug)
结局指标
主要结局
Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing
时间窗: Week 24 [end of treatment (EOT)] or early termination
University of Texas (UT) system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. UT Wound Classification (1C/2C) was based on grade (0= healed site to 3= penetrating wound to bone or joint) and stage (A= clean wounds to D= ischaemic infected wounds) of wounds. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure\>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure\<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure\>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure\<=30 mmHg and UT grade and stage 2C.
次要结局
- Number of Participants Who Underwent Any Amputation(Week 24 (EOT) or early termination)
- Number of Participants With Intact Skin Healing(Week 24 (EOT) or early termination)
- Number of Participants Who Underwent Major and Minor Amputation(Week 24 (EOT) or early termination)
- Number of Participants With Major Cardiovascular Disease Events (MCVE)(Week 24 (EOT) or early termination)
- Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)(Baseline and Week 24 (EOT or early termination))
- Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Excluding Intact Skin Healing(Week 24 (EOT) or early termination)
- Number of Participants Who Died(Week 24 (EOT) or early termination)
- 11-point Likert Pain Scale(Baseline and Week 24 (EOT or early termination))
- Time to Intact Skin Healing(Week 24 (EOT) or early termination)
- Median Time to First Amputation(Week 24 (EOT) or early termination)
- Euro Quality of Life-5 Dimensions (EQ-5D)- Utility Score(Baseline and Week 24 (EOT or early termination))
- 36-Item Short-Form Health Survey (SF-36) Score(Baseline and Week 24 (EOT or early termination))
- Transcutaneous Local Tissue Oxygenation (pO2)(Baseline and Week 24 (EOT or early termination))