Clinical trial NCT04668755: 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
Overall status: COMPLETED
Phase: NA
Conditions: Charcot Joint of Foot
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Force platform to measure peak vertical ground reaction plantar force
timeFrame: Pre-intervention
measure: Force platform to measure peak vertical ground reaction plantar force
timeFrame: Three months post-intervention
Secondary outcomes:
measure: Wound Surface area using ImageJ software
timeFrame: Pre-intervention
measure: Wound Surface area using ImageJ software
timeFrame: Three months post-intervention
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Abou Quir General Hospital
Study officials:
affiliation: faculty of physical therapy
name: Amal M Abd El Baky, PhD
role: STUDY_DIRECTOR
References: