Effect of CROW 3d Printed Sole on Charcot Foot Ulcer

Charcot Joint of Foot Clinical Trial

Official title: Effect Of Charcot Restraint Orthotic Walker Three-Dimensional Printed Sole On Charcot Foot Ulcer

Status Completed

Clinical Trial Summary

The purpose of the study is to evaluate the therapeutic effect of the Charcot Restraint Orthotic Walker three-dimensional printed sole on Charcot foot ulcer healing.

Clinical Trial Description

Foot ulcerations, Charcot neuroarthropathy, and peripheral arterial disease frequently result in gangrene and lower limb amputation. Consequently, foot disorders are leading causes of hospitalization for persons with peripheral neuropathy. Although not all foot complications can be prevented, dramatic reductions in frequency have been achieved by taking a multidisciplinary approach to patient management, The reduction of pressure to the Charcot foot ulcer is essential to treatment. Proper off-loading and pressure reduction prevents further trauma and promotes healing. This is particularly important in the peripheral neuropathy patient with decreased or absent sensation in the lower extremities. Furthermore, recent studies provide evidence that minor trauma (eg, repetitive stress, shoe pressure) plays a major role in the causal pathway to ulceration.

• Off-loading approaches that deal with Charcot neuroarthropathy will decrease the significant psychological, social and functional impact on individuals.

• The need of this study is developed from the lack of controlled studies that reported the therapeutic effect of Charcot Restraint Orthotic Walker 3d printed sole on Charcot foot ulcer.

• So the present study is designed to evaluate the Charcot Restraint Orthotic Walker 3d printed sole on Charcot foot ulcer. Furthermore, the current study may help physical therapist, physicians, and clinicians to organize a protocol of treatment that would be safe, simple and economic for treating patients with Charcot neuroarthropathy. ;

Related Conditions & MeSH terms

• Arthropathy, Neurogenic
• Charcot Joint of Foot
• Foot Ulcer

• NCT number: NCT04668755
• Study type: Interventional
• Source: Cairo University
• Status: Completed
• Phase: N/A
• Start date: December 5, 2020
• Completion date: June 1, 2021