Treatment of Digital Ulcers in Systemic Sclerosis With Diosmin: A Randomized, Double-blind, Placebo-controlled Multi-centre Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 5
- 主要终点
- Efficacy - Number (%) of healed baseline ulcers
研究概览
简要总结
This study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers). Two (2) out of three (3) participants will receive active product. The participants will have four (4) visits over eight (8) weeks. Physical exams and photos will be performed. A variety of questions will be asked describing level of pain and lifestyle changes.
详细描述
This study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers). The study will include 21-45 participants randomly given active product or inactive product (placebo). Two (2) out of every three (3) participants enrolled will receive active product. The participants will have four (4) visits over eight (8) weeks. At each visit physical exams and photos will be performed. Each person will also be asked a variety of questions describing level of pain and any changes to their lifestyle.
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)
盲法说明
All subjects de-identified, all study staff blinded, all product labeled with number assignment, randomization performed by computer, number assignment conveyed to blinded study staff via computer.
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
- •Diagnosis of systemic sclerosis (scleroderma)
- •At least one "active" digital ulcer
- •Medication for systemic sclerosis unchanged for 30 days
排除标准
- •Infection or gangrene in ulcer
- •Citrus allergy
- •Unstable heart, kidney, or liver disease
- •Active infection of any type
- •Current cancer treatment or uncured cancer
- •Pregnancy or breast feeding
研究组 & 干预措施
Placebo
Cornstarch, one (1) capsule, two (2) times per day for eight (8)
干预措施: Placebo (Other)
Active
Vasculera 630 mg, tablet, two (2) times per day for eight (8) weeks
干预措施: Diosmin (Combination Product)
结局指标
主要结局
Efficacy - Number (%) of healed baseline ulcers
时间窗: Screening, Day 1, Day 28, Day 56
Number (%) of healed baseline ulcers and change in net ulcer burden
次要结局
- Safety - number of adverse events(Screening, Day 1, Day 28, Day 56)