Offloading Interventions for Diabetic Foot Problems in Upper Egypt
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Diabetic Foot Ulcer
- 发起方
- Assiut University
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Reduction of mean ulcer radius
- 最后更新
- 5年前
概览
简要总结
Offloading is the concept of relieving pressure to help prevent/cure plantar ulcers, especially in diabetic patients. Many forms of offloading are available, with many limitations to apply in clinical practice. In this study, the investigators compare cast shoe with removable walker considering effectiveness, complications, compliance and patient's appreciation.
详细描述
Abnormal glucose metabolism gradually impairs sensation in both feet. Impaired sensation leads to recurrent attacks of inflammation "acute Charcot arthritis". Eventually, the foot becomes deformed with abnormal shape of the plantar surface. During walking, both neuropathy and deformities cause abnormal distribution of pressure with some points in the plantar surface having a very high pressure. This high pressure leads to skin ulceration "pressure ulcer". These pressure ulcers tend to be recurrent or chronic as long as the problem of high pressure is not resolved. Offloading techniques are pressure-relieving interventions that redistribute body weight over the plantar surface. Areas with high pressure which are at high risk of ulceration, are treated to decrease pressure and cure ulcers. The diabetic foot clinic at Assiut university hospital provides patients with necessary care to avoid the single most fearsome enemy, amputation. This clinic currently provides many offloading options based on expert opinion, and there is an urgent need to have a well-balanced view supported by evidence, considering both the physician and the patient. The investigators' project is to conduct a series of trials to guide policies concerned with diabetic foot problems, OIDFUA. This study will compare cast shoe with removable walker, as different offloading options to cure diabetic foot ulcers.
研究者
Mohammad Hasan AbdEllah
Principal Investigator
Assiut University
入排标准
入选标准
- •Diabetes, loss of protective sensation, forefoot pressure ulcer
排除标准
- •Ankle/Brachial index less than 0.7, severe infection
结局指标
主要结局
Reduction of mean ulcer radius
时间窗: 6 months
Mean ulcer radius is √(area/π)
Severe adverse events related to use of offloading device
时间窗: 6 months
new ulcer, acute Charcot episode, foot infection, or amputation that the patient relates to device use
Non-severe adverse events related to use of offloading device
时间窗: 6 months
abrasions, maceration, fungal infection, or falls that the patient relates to device use Non-severe means resolved within two weeks and device use resumed
次要结局
- Adherence(6 months)
- Mobility(6 months)
- Perception(6 months)
- Lifestyle limitation(6 months)
- severity of pain(6 months)