Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Diabetic Foot Ulcer
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

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 abnor...

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.

Tracking Information

NCT #
NCT03215953
Collaborators
Not Provided
Investigators
Principal Investigator: Walaa A Khalifa, MD Assiut University