NCT03215953

Offloading Interventions for Diabetic Foot Problems in Upper Egypt

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 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.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	cast shoe	ankle-high, custom-made, well-moulded cast shoe
DEVICE	removable walker	Prefabricated especially designed for relieving load on the foot

Timeline

• Start date: 2019-02-01
• Primary completion: 2020-08-01
• Completion: 2020-09-01
• First posted: 2017-07-12
• Last updated: 2020-07-15

Locations

1 site across 1 country: Egypt