Effect of CROW 3d Printed Sole on Charcot Foot Ulcer

NCT ID: NCT04668755

Last Updated: 2021-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-05
• Study Completion Date: 2021-06-01

Brief 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.

Detailed 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.

Conditions

Charcot Joint of Foot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Charcot Restraint Orthotic Walker 3d printed sole

the group fit with Charcot Restraint Orthotic Walker 3d printed sole for 12 week. the protocol of gait analysis testing starts with a reacclimation period during which the subject walked usual freely walking across the path for a duration of four minutes and then the testing session data collection done by four acceptable force platform strikes for the feet fitted with the CROW.

Group Type: ACTIVE_COMPARATOR

Charcot Restraint Orthotic Walker 3d printed sole

Intervention Type: DEVICE

The Charcot Restraint Orthotic Walker (CROW) consists of anterior and posterior shells creating a total contact environment based on a rocker sole. the sole is manufactured by 3d printed Metamaterial .

Manufacture of the 3d printed sole of the CROW paths through two stages ;Computer aided designing (CAD) and computer aided manufacturing (CAM) .

Generic Charcot Restraint orthotic walker

the group fit with Generic Charcot Restraint Orthotic Walker for 12 week.the protocol of gait analysis testing starts with a reacclimation period during which the subject walked usual freely walking across the path for a duration of four minutes and then the testing session data collection done by four acceptable force platform strikes for the feet fitted with the CROW.

Group Type: ACTIVE_COMPARATOR

Generic Charcot Restraint orthotic walker

Intervention Type: DEVICE

It is a clamshell (two piece) design that provides complete/total contact over the shin, calf and foot. The CROW reduces all motion in the ankle and foot to reduce potential for further injury. It is fully padded on the inside, and the bottom is covered with a material similar to shoe soling. It is not worn with a shoe.

Interventions

Charcot Restraint Orthotic Walker 3d printed sole

The Charcot Restraint Orthotic Walker (CROW) consists of anterior and posterior shells creating a total contact environment based on a rocker sole. the sole is manufactured by 3d printed Metamaterial .

Manufacture of the 3d printed sole of the CROW paths through two stages ;Computer aided designing (CAD) and computer aided manufacturing (CAM) .

Intervention Type: DEVICE

Generic Charcot Restraint orthotic walker

It is a clamshell (two piece) design that provides complete/total contact over the shin, calf and foot. The CROW reduces all motion in the ankle and foot to reduce potential for further injury. It is fully padded on the inside, and the bottom is covered with a material similar to shoe soling. It is not worn with a shoe.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The subject selection will be according to the following criteria: • The patient's ages will range from 45 to 65 years.

• Both sexes will be included in the study.
• Informed consent for participation in this study will be obtained in writing from all patients.

Exclusion Criteria

• The potential participants will be excluded if they meet one of the following criteria:
• Preceding surgical procedure on affected foot.
• Patients on hemodialysis.
• Patients who had any pathological conditions which may affect the results of the study as active malignancy, osteomyelitis and pes planus.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Haitham Amin Elessawy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amal M Abd El Baky, PhD

Role: STUDY_DIRECTOR

faculty of physical therapy

Locations

Abou Quir General Hospital

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

012/002367

Identifier Type: -

Identifier Source: org_study_id