NCT00235196已完成4 期
A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Full-Thickness, Neuropathic Diabetic Foot Ulcers
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- Clinical effectiveness of CAM in DFU by comparing the reduction in wound area between 2 treatment groups.
研究概览
简要总结
This is a randomized (1:1), prospective, open label, multicenter, comparative study to be examine the effectiveness of Collagen-ORC Antimicrobial matrix, a new wound dressing, on diabetic foot ulcers.
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
- 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
- •18 years of age or older.
- •Ambulatory (i.e. walking is the primary method of mobilization. Crutches, walker, walking frame or other ambulation aids are permitted).
- •Diagnosed Type 2 diabetic (i.e. not juvenile onset).
- •Have a DFU on the plantar surface of either foot.
- •Have a DFU of >4 wks but <6 months duration.
- •Willing and capable of cooperating to the extent and degree required by the study protocol
排除标准
- •Be < 1cm2 or >10cm2 in area, by planimetry.
- •Demonstrate overt signs of infection.
- •Be located on the dorsal, lateral, or posterior heel area of the foot (Change 2, Amendment 1).
- •Have visible exposed bone or tendon.
- •Have an adjacent thermal injury or wound of an etiology other than diabetes.
- •Be within 5 cm of any other wound, regardless of etiology.
- •Have received enzymatic debriding agents in the past 7 days.
- •Have received topical antibiotic therapy in the past 7 days.
- •Be less than 1 cm2 or exceed 10cm2 in area by planimetry, after debridement.
- •Have exposed bone or tendon, after debridement
- •The study subject MUST NOT:
- •Have received previous treatment for the study ulcer by this Investigator.
- •Have more than 3 full thickness ulcers, in total.
- •Be pregnant or nursing an infant
- •Have a concurrent illness or condition which may interfere with wound healing, such as carcinoma, vasculitis, immune system disorders or connective tissue disorder.
- •Be a known alcohol or drug abuser.
- •Have received systemic corticosteroids, immunosuppressive or chemotherapeutic agents in the past 30 days.
- •Have received radiotherapy, which includes the lower extremity, at any time.
- •Have a marked Charcot foot or claw foot deformity which would limit the ability of the subject to wear or be compliant with the wearing of the standardized off-loading device used in this study.
- •Have received an investigational drug or device in the past 30 days.
- •Have a known hypersensitivity to bovine collagen, oxidized regenerated cellulose (ORC) or silver.
- •Be unwilling or unable to be fitted or compliant with the wearing of an ulcer off-loading device.
- •Known to be non-compliant or unlikely to complete the study.
- •Have ABPI < 0.7, OR, if ABPI >1.0 and toe pressure >0.
- •Have serum Creatinine > 3 mg/dL
- •have Hgb A1C>9%
结局指标
主要结局
Clinical effectiveness of CAM in DFU by comparing the reduction in wound area between 2 treatment groups.
次要结局
- Rate of wound closure
- Ease of use and adverse events
- Wound odor
- Quality of life
- Wound characteristics
研究者
研究点 (5)
Loading locations...
相似试验
已完成
4 期
A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Venous Leg UlcersLeg UlcerNCT00235209Ethicon, Inc.48
招募中
不适用
EXtensive mulTilayer stEnt treatmeNt in Aortic disSectiOnType B Aortic DissectionNCT06675617Intressa Vascular SA72
Unknown
4 期
Study to Evaluate the Duration of Treatment With Ertapenem in Acute Attacks of Sigmoid DiverticulitisDiverticulitis, ColonicAcute DiseaseNCT00097734Klinikum Hanover-Siloah Hospital540
招募中
3 期
Entecavir and Tenofovir Versus Entecavir in Lymphoma Patients With Positive HBV DNAHBVB-cell LymphomaNCT04539119Ruijin Hospital120
已完成
3 期
Olaparib Tablets Maintenance Monotherapy Ovarian Cancer Patients After Complete or Partial Response to Platinum ChemotherapyRelapsed Ovarian CancerFollowing Complete or Partial Response to Platinum Based ChemotherapyPlatinum SensitiveNCT03534453AstraZeneca229