Silicone Sock as Treatment of Deep Heel Fissures in People With Diabetes -a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Proportion of healing of deep heel fissures
研究概览
简要总结
This study evaluates the addition of using a sock of silicone to using a heel cream, in the treatment of heel fissures in people with diabetes, aiming at healing the fissures and preventing them from developing into ulcers. Half of the participants will use the silicone sock and a heel cream, the other half will use the cream only.
详细描述
Dry skin and heel fissures are common complications of diabetes and can develop into hard-to-heal ulcers that eventually can make amputation of the foot necessary.
Patients are advised to use heel creams to heal fissures and prevent them from developing into ulcers. Clinical observations have suggested that wearing a silicone sock nighttime can heal fissures, but the additional advantage of using a silicone sock compared to use a heel cream only has not been investigated.
Participants will be randomized to an intervention group (silicone sock and heel cream) or a control group (heel cream only) and the healing of fissures and development of new ulcers will be compared between the groups.
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
- Single (Outcomes Assessor)
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
- •Diabetes diagnosis, and
- •Deep heel fissures
排除标准
- •Factors associated with increased risk of complications:
- •known allergy or hypersensitivity to silicone or ingredients in cream
- •other skin conditions that make use of sock or cream inappropriate
- •strongly fluctuating foot edema
- •ulcer in part of the foot that the sock is in contact with
- •inability of participant or assisting person to handle the silicone sock correctly including daily cleaning.
- •Factors associated with increased risk that complications are not discovered or reported, such as, dementia, language or other communication impairments, intellectual disability or known substance abuse, AND there is no other person who can provide adequate support to the participant.
研究组 & 干预措施
Silicone sock+heel cream
Every evening a cream (Footmender, Auxilum Cura Innovatio, Dublin, Ireland, European Patent 2522342) is applied to the feet and a sock of silicone is used every night.
干预措施: Sock of silicone (Device)
Silicone sock+heel cream
Every evening a cream (Footmender, Auxilum Cura Innovatio, Dublin, Ireland, European Patent 2522342) is applied to the feet and a sock of silicone is used every night.
干预措施: Heel cream (Other)
Heel cream
Every evening a cream (Footmender, Auxilum Cura Innovatio, Dublin, Ireland, European Patent 2522342) is applied to the feet
干预措施: Heel cream (Other)
结局指标
主要结局
Proportion of healing of deep heel fissures
时间窗: Once every 4 weeks for approx. 6 months
Heel fissures are defined as fissures involving the dermis. Participants visit a podiatrist who take a photograph later judged by a blinded assessor: presence or absence of deep fissures.
Time to healing of deep heel fissures
时间窗: Once every 4 weeks for approx. 6 months
A survival analysis is conducted on the same variable as above.
次要结局
- Severity of skin dryness(Once every 4 weeks for approx. 6 months)
- Number of participants for whom the fissures develop into ulcers(Once every 4 weeks for approx. 6 months)
- Number of participants with complications(Once every 4 weeks for approx. 6 months)
研究者
Gustav Jarl
PhD, Certified Prosthetist and Orthotist
Region Örebro County