NCT01554644撤回不适用
A Randomized, Double-Blind Exploratory Pilot Study Comparing Prontosan(TM) Versus Saline in the Cleansing of Chronic Leg Ulcers in Diabetic Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Relative (%) area wound size change versus baseline in respondents to treatment following a 12-week treatment period
研究概览
简要总结
This is a randomized controlled double blinded study involving two (2) investigational sites in the United States. All subjects (n=40) will receive either Prontosan Wound Irrigation Solution and Gel treatment or standard of care treatment (0.9% saline) and placebo gel. This is a 12-week study.
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
- Triple (Participant, Care Provider, 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 diabetic (type I or II) patients ≥ 18 years of age.
- •Diabetic ulcer(s) present for ≥ 4 weeks located below the knee.
- •A total surface area of ≥ 3 cm2 and ≤ 16 cm
- •Willingness to wear an off-loading device if medically indicated (e.g., DH shoe or Walker).
排除标准
- •Pregnant women and nursing mothers.
- •Uncontrolled diabetes as defined by glucose levels >225 mg/dl.
- •HbA1c ≥ 12%.
- •Subjects with a wound infection.
- •Subjects receiving antibiotic therapy within 14 days of enrollment.
- •Subject with history of or clinical evidence of: Cardiac insufficiency (NYHA functional classification IV), angina pectoris (CCS functional classification IV), unstable pulmonary, renal, hepatic, endocrine or hematologic disease as determined by the Investigator (serum creatinine of > 3.0; transaminase or alkaline phosphatase levels equal to or greater than 5 times the upper limit) malnutrition (albumin < 2.5 g/dL).
- •Peripheral arterial occlusive disease with a non-palpable pulse on both dorsal pedial and the posterior tibial artery.
- •Presence of gangrene.
- •Active rheumatic or collagen vascular disease (including rheumatoid arthritis, scleroderma, and systemic lupus erythematosus)
- •Subjects that have been diagnosed with HBV, HVC, AIDS or are HIV positive.
- •Osteomyelitis diagnosed by x-ray, bone biopsy, or other radiological procedure within 90 days prior to Screening Period.
- •Active radiation therapy below the hip.
- •Subject currently receiving, or has received oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents within 30 days prior to Baseline Visit (Visit 1, Week 0) or is anticipated to require such agents during the course of the study.
- •Current participation or participation in another investigational drug or medical device study within the last 30 days.
- •Subjects who test positive for alcohol and or illicit drug use.
- •Subjects who are unable to comprehend or comply with study requirements or ability to sign an informed consent.
- •Subjects, who in the opinion of the Investigator would not be a suitable candidate for this study (reason for exclusion needs to be documented).
研究组 & 干预措施
Prontosan Solution and Gel
Active Comparator
ProntosanTM Wound Irrigation Solution (PHMB 0.1%, Betaine 0.1%) and ProntosanTM Wound Gel (PHMB 0.1%, Betaine 0.1%)
干预措施: Prontosan (Device)
Saline Solution and Inert Gel
Placebo Comparator
干预措施: Saline (Device)
结局指标
主要结局
Relative (%) area wound size change versus baseline in respondents to treatment following a 12-week treatment period
时间窗: Baseline and 12 weeks
次要结局
- Change of clinical wound infection during treatment period(12-week treatment period)
- Change in absolute wound area dimensions(12-week treatment period)
- Identification of bacteria present on wound bed at baseline and follow-up(12-week treatment period)
- Relative change in bacterial load during treatment period(12-week treatment period)
- Change in wound margins determined by color photography(12-week treatment period)
- Number of "non-responders" as measured by wound size change (<50% relative wound size reduction(12-week treatment period)
研究者
研究点 (2)
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