Effects of the Use of Customized Silicone Digital Orthoses on Pre-ulcerative Lesions and Plantar Pressure During Walking in People With Diabetic Neuropathy: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Baseline Pre-ulcerative lesions and ulcers at 12 and 24 weeks
研究概览
简要总结
The present study aims to evaluate the efficacy and safety of the use of customized silicone digital orthoses for six months in the distribution of plantar pressure, in the reduction of pre-ulcerative lesions and plantar ulcers in the forefoot, foot deformities, quality of life and foot health and functionality in people with diabetes and neuropathy with risk category 2 and 3 for ulcers, according to the International Working Group on Diabetic Foot.
详细描述
The present study aims to evaluate the effects and safety of the use of customized silicone digital orthoses for six months in the plantar pressure distribution during gait, in the reduction of pre-ulcerative lesions and plantar ulcers at forefoot, in functional balance, foot deformities, quality of life and foot health and functionality in people with diabetes and and diabetic neuropathy with risk category 2 and 3, according to the International Working Group on Diabetic Foot.
The sample will consist of 60 participants, who will be randomly allocated, in a randomized controlled clinical trial, in the control or intervention groups and evaluated at baseline, 3 and 6 months of follow up. The assessment includes (1) classification of the risk of foot ulceration, (2) analysis of plantar pressure during gait, (3) quality of life, (4) foot deformities, (5) pre-ulcerative lesions, (6) functionality and general health of the feet, (6) Metatarsophalangeal joint range of motion (ROM).
The hypothesis of this study is that the intervention group will present a reduction in the peak pressures during gait, a reduction in hyperkeratosis at forefoot, a reduction in the incidence and recurrence of forefoot ulcerations, and improved quality of life and in the functionality and health of the foot, when compared to the control group after six months of use of silicone digital orthoses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Single
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
- •Diagnosed type 1 or 2 diabetes, with diabetic peripheral neuropathy confirmed by loss of sensitivity measured by 10 g Semmes-Weinstein monofilament or 128Hz tuning fork and by the fuzzy score (www.usp.br/labimph/fuzzy);
- •Presence of 1 or more deformities at the forefoot region (claw toes, hammer toes, mallet toes, overlapping toes, hallux valgus, prominence of the metatarsal heads or reduction/displacement of the fat pad);
- •Ability to walk independently with or without the aid of a walking device;
排除标准
- •Presence of other diagnosed neurological diseases;
- •Presence of dementia or inability to give consistent information;
- •Presence of major vascular complications;
- •Receiving any physiotherapy intervention;
- •Major vascular complications (ischemia)
- •Presence of an active ulcer at the time of baseline assessment;
- •Major amputations;
- •Minor amputations, except toes.
研究组 & 干预措施
Intervention Group
The participants will receive a custom silicone digital orthosis (CSDO) to realign the toes according to their needs. They will be instructed to use the CSDO throughout the day, remove it to sleep and reposition it on the foot the next day. Furthermore they will be assisted by a stomatherapy specialist, dermatology or clinical podiatry nurse and will receive foot care for thinning the calluses, referral (if necessary) to the Specialized Rehabilitation Center - CER, health equipment linked to SUS, for the purchase of insoles and/ or molded footwear (when indicated) and guidance on the use of therapeutic footwear.
干预措施: Custom silicone digital orthosis (CSDO) (Device)
Control Group
The participants will be assisted by the stomatherapy specialist, dermatology or clinical podiatry nurse and will receive foot care for thinning the calluses, referral (if necessary) to the Specialized Rehabilitation Center - CER, health equipment linked to SUS, for the purchase of insoles and/ or molded footwear (when indicated) and guidance on the use of therapeutic footwear.
结局指标
主要结局
Change from Baseline Pre-ulcerative lesions and ulcers at 12 and 24 weeks
时间窗: 12 and 24 weeks
It will be evaluated according to a study, which classifies hyperkeratosis into 6 degrees
次要结局
- Change from Baseline Safety at 12 and 24 weeks(12 and 24 weeks)
- Change from Baseline Comfort at 12 and 24 weeks(12 and 24 weeks)
- Change from Baseline Satisfaction at 12 and 24 weeks(12 and 24 weeks)
- Range of motion (ROM) of the metatarsophalangeal joint at 12 and 24 weeks(12 and 24 weeks)
- Change from Baseline Dynamic Plantar Pressure Distribution during gait at 12 and 24 weeks(12 and 24 weeks)
- Change from Baseline Foot health and functionality at 12 and 24 weeks(12 and 24 weeks)
- Change from baseline of the Quality of life at 12 and 24 weeks(12 and 24 weeks)
研究者
Isabel de Camargo Neves Sacco
Associate Professor
University of Sao Paulo General Hospital