A Randomized, Double-Blind, Placebo-Controlled, Dose Response Study of the Safety and Efficacy of Thymosin Beta 4 in the Treatment of Patients With Pressure Ulcers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 12
- 主要终点
- Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Pressure Ulcers
详细描述
The purpose of this double-blind, placebo-controlled, dose-escalation study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 (Tβ4), administered topically, in patients with Pressure Ulcers (PU). PU is caused by prolonged pressure or rubbing of the body in areas prone to moisture and friction. PU affects primarily elderly, bedridden patients. Tβ4 is a synthetically-produced copy of a naturally-occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression of laminin-5.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Use of any experimental drug, or participation in any clinical study, within the 60 days before enrollment
- •Use of immunotherapy, or cytotoxic chemotherapy within the 60 days before enrollment. Systemic steroids not allowed 30 days prior to enrollment. Topical therapy other than steroidal is allowed up to 7 days prior to enrollment
- •History of adverse events to any ingredients of study medication
- •Neurological, cardiovascular, respiratory, hepatic, renal, or metabolic disease likely to interfere with the patient's participation in or completion of the study
- •Arterial or venous disorder resulting in ulcerated wounds
- •Diabetes mellitus except if disease is determined to be under control with a glycosylated hemoglobin ≤8.5% of total hemoglobin
- •Pregnancy or breastfeeding during the study. (A serum pregnancy test will be performed at Screening for female patients of childbearing potential.)
研究组 & 干预措施
1
0.00% thymosin beta 4 w/w administered topically once daily for up to 84 days
干预措施: Placebo (Drug)
2
3 doses of thymosin beta 4: 0.01% w/w, 0.02% w/w, and 0.1% w/w, administered topically once daily for up to 84 days
干预措施: Thymosin Beta 4 (Drug)
结局指标
主要结局
Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days
时间窗: Up to 84 days
All Treatment-Emergent Serious Adverse Events (SAEs) and AEs by treatment dose safety population
次要结局
- Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days(Up to 84 days)