NCT00368602终止2 期
Beta Adrenergic Receptor Modulation of Burn Wound Healing
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The primary efficacy parameter will be complete ulcer healing, which is defined as 100% epithelialization with no drainage or need for an absorptive dressing.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of treatment of chronic cutaneous ulcers and burn wounds with topical beta adrenergic antagonists (Timoptic®).
详细描述
The purpose of this study is to learn more about how to heal venous leg ulcers faster and to test the safety of a drug and see what effects it has on a venous leg ulcer.
You will:
- be interviewed and examined
- have a physical exam
- have blood and urine tested
- have photographs taken of the wound
- apply medication to the leg ulcer as directed
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any race btwn 18 and 85 years of age, inclusive;
- •Male or female, neither pregnant nor lactating.
- •Informed consent;
- •Have at least 1 lower extremity ulcer in the gaiter area (knee to ankle):
- •Surface area of ≥2 sq. cm. to ≤20 sq. cm.; Ulcer with largest surface area meeting inclusion criteria will be selected.
- •If 2 ulcers present with the same surface area, ulcer of longest duration selected.
- •Study ulcer must be at least 2 cm from any other ulcer on same extremity.
- •A viable wound bed free of necrotic tissue post-debridement, if debridement is indicated.
- •Have an Ankle Brachial Index (ABI) >0.7;
- •Presence of either dorsalis pedis or posterior tibialis pulses by Doppler on the study extremity;
- •Have a non-healing (open) ulcer for at least 1 month. Subjects who failed conservative therapy are eligible for the study;
- •Comply with a trial (13 to 17 days) of protocol-specified standard care prior to randomization;
- •Two or more of the following: dermatitis, atrophie blanche, varicosities, hyperpigmentation or lipodermatosclerosis;
排除标准
- •Decrease in wound surface area of >35% btwn Screening and Visit 1 (Randomization);
- •Cellulitis, osteomyelitis, ulcer with exposed bone, tendon or fascia, or purulent exudates in ulcer area;
- •Grade IV ulcer;
- •Evidence of study ulcer infection;
- •Study ulcer of non-venous etiology;
- •Acquired or are known to be infected with HIV;
- •Uncontrolled diabetes mellitus;
- •Immunodeficiency as defined by serum IgG, IgA, and IgM less than one-half the lower limit of normal;
- •Severe protein malnutrition as defined by serum albumin <2.5 g/dL;
- •Severe anemia defined as a total of hemoglobin of <10 g/dL for males or <8 g/dL for females;
- •Chronic renal insufficiency requiring dialysis;
- •Serum aspartate aminotransferase (AST, SGOT, GOT) or serum alanine aminotransferase (ALT, SGPT, GPT) levels greater than twice the upper limit of normal;
- •New York Heart Association Functional Classification of IV;
- •Deep vein thrombosis (DVT) w/in last 6 weeks or clinical evidence of current DVT;
- •Arterial revascularization of the study extremity w/in previous 6 months from the date of Screening Visit;
- •History, w/in previous 12 months from date of Screen Visit, of alcohol or drug abuse, particularly methadone or heroin;
- •Received previous treatment with the following during the 60 days prior to Screening: Immunosuppressive agents, radiation, chemotherapy, growth factors at the site of the study ulcer, split- or full-thickness skin graft at the site of the study ulcer, biologically-active cellular or acellular product(s) at the site of the study ulcer, investigational drug or device
- •Received previous treatment with systemic corticosteroids prior to Screening (Chronic corticosteroids w/in 90 days or short course corticosteroids w/in 30 days)
- •Been hospitalized for treatment of any venous ulcer w/in the previous 30 days from Screening.
- •Asthma or a history of asthma, obstructive pulmonary disease, myasthenia gravis, hyperthyroidism, history of heart block
研究组 & 干预措施
1
Experimental
This group receives topical beta adrenergic antagonists (Timoptic) plus standard of care.
干预措施: Timoptic (Drug)
2
Placebo Comparator
The group will be given standard of care with placebo medication.
干预措施: Placebo (Other)
结局指标
主要结局
The primary efficacy parameter will be complete ulcer healing, which is defined as 100% epithelialization with no drainage or need for an absorptive dressing.
时间窗: 12 weeks
次要结局
- 100% re-epithelialization will be clinically determined at each visit by the Investigator.(12 weeks)
研究者
研究点 (1)
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