Clinical Trial Phase I-II of Efficacy and Safety of Snail Slime and Natural Extracts for Healing in Diabetic Foot Ulcers
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Incidence rate of healing until 60 days or less
研究概览
简要总结
The primary objective is to evaluate the efficacy and safety of the use of a formulation of snail slime and natural extracts, for the curative treatment of ulcer wonds in diabetic foot.
The secondary objetives:
- To evaluate the efficacy of the use of a formulation of snail slime Helix aspersa Müller and natural extracts (MU001) for the curative treatment of ulcer wonds in diabetic foot with respect to the standard of care, by means the application of patchs that containing the formulation in a treatment period of until 60 days.
- To determine the safety of the use of a formulation of snail slime Helix aspersa Müller and natural extracts (MU001) in diabetic individuals in a treatment period of until 60 days.
详细描述
Clinical Study of phase I-II, controlled, simple blind (in relation with biostatistical analysis), randomized, of formulation that containing snail slime Helix aspersa Müller (Cryptophalus aspersus), natural calendula extract, propolis and excipients (MU001).
The formulation in study MU001 wil be added to the standard of care for healing in diabetic foot indicated. The period of recruitment estimated will be 4 month and the follow-up of the patients will be of until 60 days.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes type 2
- •Unilateral ulcers
- •Grade 1 or grade 2 Wagner ulcers.
- •Without infection (except onychomycosis)
- •Network family, hygiene, adherence and compliance appropiated
排除标准
- •Bilateral ulcers
- •Medical conditions with high risk (cancer, allergies)
- •Consum of abuse drugs
研究组 & 干预措施
MU001 patches (Investigational)
Patches MU001 (snail slime, calendula extract and propolis extract) more standard of care. Two or three application for week. Treatment until 60 days.
Patches MU001 (snail slime, calendula extract and propolis extract) on health zone. Three days of treatment.
干预措施: MU001 patches (Investigational) (Drug)
Conventional patches (Control)
Conventional patches approved for diabetic foot ulcers more standard of care. Two or three application for week. Treatment until 60 days.
干预措施: Conventional patches (Control) (Device)
结局指标
主要结局
Incidence rate of healing until 60 days or less
时间窗: 60 days
Incidence of healing measured with Wagner ulcer classification
次要结局
- Time to healing until 60 days or less(60 days)
- Incidence of treatment-emergent adverse events (Safety and Tolerability) of a formulation of snail slime and natural extracts in ulcer wounds in diabetics foot(60 days)
- Incidence of treatment-emergent adverse events (Safety and Tolerability) of a formulation of snail slime and natural extracts in healthy skin(3 days)
研究者
Luis Quiñones Sepulveda
Dr.
University of Chile