NCT01497210已完成2 期
A Prospective, Multi-centre, Non-comparative Study to Evaluate the Safety and Preliminary Performance of the EASH Dressing on Chronic Venous Leg Ulcers
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 10
- 主要终点
- Safety
研究概览
简要总结
The primary objective of this study is to evaluate the safety and preliminary performance of EASH dressing for 4 weeks followed by AQUACEL® dressing for 4 weeks on venous leg ulcers.
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
- •Subjects over 18 years, willing and able to provide written informed consent.
- •Subjects who have an ankle to brachial pressure index (ABPI) of 0.8 or greater
- •Subjects who have a venous leg ulcer (i.e. CEAP classification of C6 1), with duration less than 24 months and size ranging between 5 cm2-40 cm
- •Subjects' leg ulcers will meet at least 3 of the 5 following clinical signs of infection: pain between two dressing changes, peri-ulcer skin erythema/inflammation, oedema, malodour (foul odour), and heavy exudate.
- •Subjects who agree to wear compression therapy daily in combination with the trial dressing.
排除标准
- •Subjects with a history of skin sensitivity to any of the components of the study product.
- •Subjects who have had current local or systemic antibiotics in the week prior to inclusion with the exception of wounds that are considered to be clinically infected at baseline.
- •Subjects whose leg ulcers are malignant, or who have had recent deep venous thrombosis or venous surgery within the last 3 months.
- •Subjects who have progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents
- •Subjects exhibiting any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study
- •Subjects who have participated in a clinical study within the past month.
研究组 & 干预措施
EASH
Experimental
干预措施: EASH dressing (Device)
结局指标
主要结局
Safety
时间窗: All 8 weeks
Nature and frequency of adverse events.
次要结局
- Ulcer Improvement (wound bed)(Baseline, week 4 and week 8)
- Ulcer Improvement (peri-ulcer)(Baseline, week 4 and week 8 or final visit)
- Ulcer pain(Weekly for 4 weeks then biweekly for 4 weeks or final visit)
- Comfort(Weekly for 4 weeks then biweekly for 4 weeks)
- Ease of use(Weekly for 4 weeks then biweekly for 4 weeks)
- Healing(8 weeks or final visit)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
不适用
A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical ProceduresPediatric Surgical ProceduresAdult Surgical ProceduresAdult Gynecological ProceduresAdult Urological ProceduresAdult Thoracic ProceduresNCT06608485Ethicon Endo-Surgery173
招募中
不适用
The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot StudyMitral Valve InsufficiencyNCT04343313Half Moon Medical30
撤回
不适用
Percutaneous Ultrasonic Tenotomy Versus Platelet Rich Plasma for Gluteal TendinopathyGluteal TendinitisTrochanteric BursitisTendinopathyNCT04299802Andrews Research & Education Foundation
已完成
2 期
Efficacy and Safety Study of EscharEx to Treat (Debride) Hard to Heal WoundsHard to Heal WoundsVenous Leg UlcersDiabetic Lower Extremity UlcersTraumatic/ Post Operative WoundsNCT02020746MediWound Ltd111
已完成
1 期
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 (Andecaliximab) in Adults With Moderate to Severe Active Ulcerative ColitisUlcerative ColitisNCT01831427Gilead Sciences74