Effect of CROW 3d Printed Sole on Charcot Foot Ulcer

NCT04668755 | Completed

• 1 other identifier: 012/002367
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Charcot Joint of Foot

Outcome Measures

Primary Outcomes (2)

• Force platform to measure peak vertical ground reaction plantar force

  Plantar vertical ground reaction force obtained at a rate of 100 Hz measured by Nintendo Wii Balance Board (WBB Nintendo Co. Ltd. Kyoto, Japan) through a four strain gauge sensors (uniaxial vertical force transducers) located at the corners of the board with a usable size of 45 x 26.5 cm were used for data collection; wirelessly via Bluetooth by using third party software illustrates the peak vertical force parameter.

  Pre-intervention

• Force platform to measure peak vertical ground reaction plantar force

  Plantar vertical ground reaction force obtained at a rate of 100 Hz measured by Nintendo Wii Balance Board WBB (Nintendo Co. Ltd. Kyoto, Japan) through a four strain gauge sensors (uniaxial vertical force transducers) located at the corners of the board with a usable size of 45 x 26.5 cm were used for data collection; wirelessly via Bluetooth by using third party software illustrates the peak vertical force parameter

  Three months post-intervention

Secondary Outcomes (2)

• Wound Surface area using ImageJ software

  Pre-intervention

• Wound Surface area using ImageJ software

  Three months post-intervention

Study Arms (2)

Charcot Restraint Orthotic Walker 3d printed sole

ACTIVE COMPARATOR

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.

Device: Charcot Restraint Orthotic Walker 3d printed sole

Generic Charcot Restraint orthotic walker

ACTIVE COMPARATOR

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.

Device: Generic Charcot Restraint orthotic walker

Interventions

Charcot Restraint Orthotic Walker 3d printed sole 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) .

Charcot Restraint Orthotic Walker 3d printed sole

Generic Charcot Restraint orthotic walker 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.

Generic Charcot Restraint orthotic walker

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Abou Quir General Hospital

Alexandria, Egypt

Location

Study Officials

• Amal M Abd El Baky, PhD

  faculty of physical therapy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: * Sixty patients with Charcot neuroarthropathic foot ulcer (Chronic stage) recruited in the study. * Patients divided in to two equal groups in number: * Group A (Study group): This group compose of 30 patients whom they received the same standard medical treatment as group B in addition fitting with Charcot Restraint Orthotic Walker 3d printed sole for 12 weeks. \- Group B (Control group): This group compose of 30 patients whom they received the standard medical treatment in addition fitting with Generic Charcot Restraint Orthotic Walker for 12 weeks.

Study Record Dates

• First Submitted: December 5, 2020
• First Posted: December 16, 2020
• Study Start: December 5, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 25, 2021

Record last verified: 2021-06

Locations

EG (1)