Effect of Self-structured Foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence Post Healing at Least One Month
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The number of plantar foot diabetic ulcer recurrence incidence
研究概览
简要总结
The incidence of diabetic foot ulcer recurrence in one year can reach 35%. Plantar foot diabetic foot ulcer is the most frequently diabetic foot ulcer recurrence. The recurrence incidence can occur at least 14 days after the diabetic foot ulcer has healed. Physical activity and exercise are highly recommended for the prevention of diabetic foot ulcers. The study about the form of foot exercise to prevent a diabetic foot ulcer recurrence is still unclear. The major hypothesis was there is an effect of self-structured foot exercise on the plantar foot diabetic ulcer recurrences. The minor hypothesis was (1) The improvement of HbA1c, ABI, diabetic neuropathy examination score, callus, and walking speed can decrease the incidence of plantar foot diabetic ulcer (2) a self-structured foot exercise can decrease the incidence and the speed of incidence plantar doot diabetic ulcer recurrence. Participants were randomized into two groups: Exercise group (n=25) and control group (n=25). The exercise is the combination of flexibility and resistance exercise using a flexible band in 24 weeks. The incidence of plantar diabetic foot ulcers was monitored through the research process.
详细描述
- Introduction
Diabetic foot ulcers are a form of diabetes mellitus (DM) patients' foot problems, characterized by chronic wounds below the ankle, which can penetrate the skin to the dermis. Meta-analysis results in 2016 showed a global prevalence of diabetic foot ulcers of 6.3%. The incidence in Indonesia reaches 7.3 - 24%.
Diabetic foot ulcers can result in amputation and even death in patients. The diabetic foot ulcer caused 85% of foot amputation cases and 2.48 times higher than for patients without ulcers in the next five years. Diabetic foot ulcers can provide a high economic burden for patients, families, and the country due to the healing period of diabetic foot ulcers and expensive maintenance costs.
Healed diabetic foot ulcers can undergo recurrence. Approximately 26 -78% of all diabetic foot ulcer incidents are recurrence events. Prevalence of recurrence globally within one year, three years, and five years after diabetic foot ulcer healing is 40%, 60 %, and 65%. The prevalence of diabetic foot ulcer recurrence in Semarang, Indonesia country reaches 35.4 %. It indicates that post-cured diabetic foot ulcer patients have a very high risk for recurrence of diabetic foot ulcers.
The high incidence of diabetic foot ulcer recurrence is closely related to the biological and behavioral factors of patients who have not been resolved, despite the healing. The previous studies explained that the risk factors for diabetic foot ulcer recurrence after recovery include the location of plantar ulcers, HbA1c > 7,5%, peripheral artery disease, peripheral neuropathy, the absence of callus, duration of ulcers, duration of DM, and limitations of foot musculoskeletal function.
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
The investigator didn't know the groups. The assessor didn't know the groups
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed an informed consent
- •aged 40-60 years
- •can walk within 5 meters
- •recently healed plantar foot diabetic ulcer (1-12 months)
排除标准
- •post amputation of right and left lower limb
- •contracture of lower limb
- •parkinson's
- •osteomyelitis history
- •paralysis
结局指标
主要结局
The number of plantar foot diabetic ulcer recurrence incidence
时间窗: up to 24 weeks
The number of plantar foot diabetic ulcer recurrence incidence after healing of the last plantar foot diabetic ulcer at least 1 month. The measurement of diabetic foot ulcer by the specialist doctor using Wagner diabetic ulcer classification
The time of plantar foot diabetic ulcer recurrence incidence
时间窗: up to 24 weeks
The time of plantar foot diabetic ulcer recurrence incidence is found after healing of the last plantar foot diabetic ulcer at least 1 month.
次要结局
- change of ankle brachial index (ABI)(from the date of assignment until the date of plantar foot diabetic ulcer recurrence found, whichever comes first, assessed up to 12 weeks and 24 weeks)
- change of HbA1c level(from the date of assignment until the date of plantar foot diabetic ulcer recurrence found, whichever comes first, assessed up to 12 weeks and 24 weeks)
- change of diabetic neuropathy examination (DNE) score(from the date of assignment until the date of plantar foot diabetic ulcer recurrence found, whichever comes first, assessed up to 12 weeks and 24 weeks)
- change of walking speed(from the date of assignment until the date of plantar foot diabetic ulcer recurrence found, whichever comes first, assessed up to 12 weeks and 24 weeks)
- callus(from the date of assignment until the date of plantar foot diabetic ulcer recurrence found, whichever comes first, assessed up to 12 weeks and 24 weeks)
研究者
Maria Suryani
PhD (candidate)
St Elisabeth School Health Science