NCT00638872已完成4 期
Diabetic Foot Ulcers and Use of PDRN (Polydeoxyribonucleotide -Placentex Mastelli) as a Treatment for Wound Healing.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 215
- 试验地点
- 1
- 主要终点
- reduction of ulcer rate
研究概览
简要总结
The main objective of the study is to evaluate the efficacy of the polydeoxyribonucleotide in improving the healing of diabetic foot ulcers.
详细描述
This trial will involve diabetic patients with foot ulcers who meet the inclusion/exclusion criteria. At least 200 patients aged 45-80yrs will be enrolled in the study and randomly allocated to receive the active drug or the placebo in indistinguishable formulations. After 2 months closure rate of the ulcer will be evaluated.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 45-80yrs
- •Minimum schooling 5yrs
- •Type I or II diabetes since at least 5yrs with a stable metabolic control
- •Foot ulcer since minimum 2 weeks
- •Ulcer >1cm and <16cm at day 0
- •Ulcer grade 1 or 2 wagner scale
- •Wound free of necrotic debris
- •TcPO2 >29mmHg
- •Not pregnant or lactant
排除标准
- •Non-consenting patient
- •History of alcohol or drug abuse
- •Gangrene on any part of the affected foot
- •Ongoing untreated infections
- •Ulcer over a charcot deformity
- •Use of a systemic cicatrizant drug in the past 10 days
- •Malnutrition
- •Neurological or psychiatric pathologies
- •Liver or kidney insufficiency
- •Corticosteroid or immunosuppressive or cytotoxic therapy
- •Other severe pathologies
- •Proven hypersensitivity to the drug or to any related component
研究组 & 干预措施
1
Experimental
PDRN
干预措施: Polydeoxyribonucleotide (Drug)
placebo
Placebo Comparator
placebo
干预措施: 0.9% NaCl (Other)
结局指标
主要结局
reduction of ulcer rate
时间窗: 3 months
次要结局
- safety and tolerability of the compound(6 months)
研究者
Francesco Squadrito
Full Professor of Pharmacology
University of Messina
研究点 (1)
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