Effect Of Charcot Restraint Orthotic Walker Three-Dimensional Printed Sole On Charcot Foot Ulcer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Force platform to measure peak vertical ground reaction plantar force
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 45 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Charcot Restraint Orthotic Walker 3d printed sole (Device)
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.
Intervention: Generic Charcot Restraint orthotic walker (Device)
Outcomes
Primary Outcomes
Force platform to measure peak vertical ground reaction plantar force
Time Frame: Three months post-intervention
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
Time Frame: Pre-intervention
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 Outcomes
- Wound Surface area using ImageJ software(Three months post-intervention)
- Wound Surface area using ImageJ software(Pre-intervention)
Investigators
Haitham Amin Elessawy
Principal Investigator
Cairo University
