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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
68
ankle-high, custom-made, well-moulded cast shoe
Prefabricated especially designed for relieving load on the foot
Assiut University Hospital
Asyut, Egypt
RECRUITINGReduction of mean ulcer radius
Mean ulcer radius is √(area/π)
Time frame: 6 months
Non-severe adverse events related to use of offloading device
abrasions, maceration, fungal infection, or falls that the patient relates to device use Non-severe means resolved within two weeks and device use resumed
Time frame: 6 months
Severe adverse events related to use of offloading device
new ulcer, acute Charcot episode, foot infection, or amputation that the patient relates to device use
Time frame: 6 months
Adherence
patient's subjective estimation of days per week and hours per day wearing the device of the total days/hours
Time frame: 6 months
Perception
patient's own opinion regarding his overall appreciation as a visual analogue score
Time frame: 6 months
severity of pain
patient's own opinion regarding pain as a visual analogue score
Time frame: 6 months
Mobility
patient's own opinion regarding limitation of mobility as visual analogue score
Time frame: 6 months
Lifestyle limitation
patient's own opinion regarding how far the device interferes with his daily activities by naming the activities that needed more effort, e.g. bathing, or stopped, e.g. going to work.
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Time frame: 6 months