Effect of CROW 3d Printed Sole on Charcot Foot Ulcer
Condition: Charcot Joint of Foot
MeSH terms: Arthropathy, Neurogenic; Foot Ulcer
Study type: Interventional

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.
    

Intervention name(s): Charcot Restraint Orthotic Walker 3d printed sole; Generic Charcot Restraint orthotic walker
Intervention type(s): Device; Device
Intervention description(s): 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) .; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Investigator)
Primary purpose: Treatment