NCT01199588已完成2 期
A Randomized, Parallel Group, Dose-Ranging, Controlled, Multi-Center Study to Assess the Efficacy and Safety of Nexagon® in the Treatment of Subjects With a Venous Leg Ulcer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 33
- 主要终点
- Surface area reduction
研究概览
简要总结
This study is for subjects with a venous leg ulcer. The study is being done to determine if NEXAGON plus compression bandaging is more effective that placebo plus compression bandaging.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of venous leg ulceration supported by venous duplex ultrasonography demonstrating venous reflux > 0.5 seconds
- •Ankle brachial index of > 0.80
- •Venous Leg Ulcer (VLU) area greater than 2 cm2 and less than 20 cm2
- •Compliant with and able to tolerate high compression bandaging
- •VLU present for > 30 days prior to study entry
- •VLU is full thickness
- •The subject is willing and able to give informed consent
排除标准
- •Decrease or increase in the ulcer surface area by more than 40% during the 14 day run-in period
- •More than 75% of the VLU is on or below the malleolus
- •Presence of a non-study ulcer within 1.5 cm of the VLU
- •A VLU which shows signs of clinical infection or has cellulitis
- •The VLU wound bed has exposed bone, tendon or fascia
- •BMI > 45.0 kg/m2
- •Subject is not ambulatory
- •Subjects who have a past or present disease that, which as judged by the Investigator, may affect the safety of the subject or the outcome of the study
- •Cancerous cells in the VLU
- •HbA1c >10%
- •Blood biochemistry >3x upper limit of normal
- •Heart failure NYHA class III or IV
- •Subjects on renal replacement therapy
- •Immunocompromized subjects
研究组 & 干预措施
Nexagon® High Dose
Experimental
Weekly applications of Nexagon® high dose in addition to compression dressings.
干预措施: Nexagon® High Dose (Drug)
Nexagon® Vehicle
Placebo Comparator
Weekly applications of Nexagon® Vehicle in addition to compression dressings.
干预措施: Nexagon® Vehicle (Drug)
Nexagon® Low Dose
Experimental
Weekly applications of Nexagon® low dose in addition to compression dressings.
干预措施: Nexagon® Low Dose (Drug)
结局指标
主要结局
Surface area reduction
时间窗: 10 weeks
次要结局
- Incidence of ulcer recurrence(12 weeks post closure)
- Pain(10 weeks)
- Incidence of adverse events(10 weeks)
- Time to complete closure(10 weeks)
- Incidence of complete closure(10 weeks)
研究者
研究点 (33)
Loading locations...
相似试验
已完成
3 期
Pivotal Trial of Dermagraft(R) to Treat Venous Leg UlcersVenous Leg UlcerNCT00909870Organogenesis537
已完成
不适用
A RCT Evaluating the Clinical Benefit of a Silver Dressing in the Treatment of Venous Leg UlcersWound HealNCT05923749Coloplast A/S180
Unknown
不适用
Elastic Compression in Chronic Venous DiseaseVaricosityNCT02641600University of Patras30
Unknown
3 期
Safety and Efficacy Study of ICXP007 With Compression Bandaging for the Treatment of Non-Infected Venous Leg UlcersLeg UlcerNCT00232973Intercytex396
已完成
4 期
Efficacy on Pain Following a Procedure for Injecting Sclerotherapeutic Foam Into the Great Saphenous VeinVenous DiseaseNCT01368159Le Club Mousse120