Effect of CROW 3d Printed Sole on Charcot Foot Ulcer

Cairo University (CU)

Status: Completed

Conditions: Charcot Joint of Foot

Treatments: Device: Generic Charcot Restraint orthotic walker; Device: Charcot Restraint Orthotic Walker 3d printed sole

Study type: Interventional

Funder types: Other

Identifiers

NCT04668755

012/002367

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Charcot Restraint Orthotic Walker 3d printed sole

Active Comparator group

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.

Treatment:

Device: Charcot Restraint Orthotic Walker 3d printed sole

Generic Charcot Restraint orthotic walker

Active Comparator group

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.

Treatment:

Device: Generic Charcot Restraint orthotic walker