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Effect of CROW 3d Printed Sole on Charcot Foot Ulcer

Primary Purpose

Charcot Joint of Foot

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Charcot Restraint Orthotic Walker 3d printed sole
Generic Charcot Restraint orthotic walker
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Charcot Joint of Foot

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Abou Quir General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Charcot Restraint Orthotic Walker 3d printed sole

Generic Charcot Restraint orthotic walker

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Wound Surface area using ImageJ software
The patient is positioned in a comfortable position with exposure of the wound. A ruler as a reference is place directly flat and attach to the skin around the wound area. A photographs were taken including the reference ruler in the images that is captured for the whole wound margins taking in consideration standardization the same angle of capture in the flat mid foot ulcers, but in case of ulcers extend to foot edge, a sterilized transparent grid film (1x1 cm) attached flat on the ulcer then wound margins traced on the transparent grid film and then photographed, then the captured photographs is exported to the computer to be visualized with ImageJ 1.52t software. Surface area measurement of wound margins are traced by the same investigator to establish reliability of measurements
Wound Surface area using ImageJ software
The patient is positioned in a comfortable position with exposure of the wound. A ruler as a reference is place directly flat and attach to the skin around the wound area. A photographs were taken including the reference ruler in the images that is captured for the whole wound margins taking in consideration standardization the same angle of capture in the flat mid foot ulcers, but in case of ulcers extend to foot edge, a sterilized transparent grid film (1x1 cm) attached flat on the ulcer then wound margins traced on the transparent grid film and then photographed, then the captured photographs is exported to the computer to be visualized with ImageJ 1.52t software. Surface area measurement of wound margins are traced by the same investigator to establish reliability of measurements

Full Information

First Posted
December 5, 2020
Last Updated
June 23, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04668755
Brief Title
Effect of CROW 3d Printed Sole on Charcot Foot Ulcer
Official Title
Effect Of Charcot Restraint Orthotic Walker Three-Dimensional Printed Sole On Charcot Foot Ulcer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 5, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Charcot Joint of Foot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Charcot Restraint Orthotic Walker 3d printed sole
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Generic Charcot Restraint orthotic walker
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Charcot Restraint Orthotic Walker 3d printed sole
Intervention Description
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
Intervention Name(s)
Generic Charcot Restraint orthotic walker
Intervention Description
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.
Primary Outcome Measure Information:
Title
Force platform to measure peak vertical ground reaction plantar force
Description
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.
Time Frame
Pre-intervention
Title
Force platform to measure peak vertical ground reaction plantar force
Description
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
Time Frame
Three months post-intervention
Secondary Outcome Measure Information:
Title
Wound Surface area using ImageJ software
Description
The patient is positioned in a comfortable position with exposure of the wound. A ruler as a reference is place directly flat and attach to the skin around the wound area. A photographs were taken including the reference ruler in the images that is captured for the whole wound margins taking in consideration standardization the same angle of capture in the flat mid foot ulcers, but in case of ulcers extend to foot edge, a sterilized transparent grid film (1x1 cm) attached flat on the ulcer then wound margins traced on the transparent grid film and then photographed, then the captured photographs is exported to the computer to be visualized with ImageJ 1.52t software. Surface area measurement of wound margins are traced by the same investigator to establish reliability of measurements
Time Frame
Pre-intervention
Title
Wound Surface area using ImageJ software
Description
The patient is positioned in a comfortable position with exposure of the wound. A ruler as a reference is place directly flat and attach to the skin around the wound area. A photographs were taken including the reference ruler in the images that is captured for the whole wound margins taking in consideration standardization the same angle of capture in the flat mid foot ulcers, but in case of ulcers extend to foot edge, a sterilized transparent grid film (1x1 cm) attached flat on the ulcer then wound margins traced on the transparent grid film and then photographed, then the captured photographs is exported to the computer to be visualized with ImageJ 1.52t software. Surface area measurement of wound margins are traced by the same investigator to establish reliability of measurements
Time Frame
Three months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal M Abd El Baky, PhD
Organizational Affiliation
faculty of physical therapy
Official's Role
Study Director
Facility Information:
Facility Name
Abou Quir General Hospital
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

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Effect of CROW 3d Printed Sole on Charcot Foot Ulcer

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