Customized Shoe-padding Orthotics for Plantar Fasciitis

Plantar Fasciitis of Both Feet Clinical Trial

Official title:

Integrated 3D Surface Scanning System Combined With Soft Tissue and Skeleton Information: Customized Shoe-padding Orthotics for Plantar Fasciitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03226288
• Other study ID #: 201704063RIND
• Status: Recruiting
• Phase: N/A
• First received: July 19, 2017
• Last updated: July 23, 2017
• Start date: February 9, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: July 2017
• Source: National Taiwan University Hospital
• Contact: Wei-tung Kao
• Phone: +886-2-2312-3456
• Email: toqi0715[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

While human body receives large external force or motions, minor injuries to the soft tissues will be produced and will lead to acute or chronic inflammation reactions. Plantar fasciitis is the most common foot diseases in normal population. Plantar fascia is a tight band-like soft tissue that crosses between the bony surfaces of the bottom of the foot with thick ligament-like structure substantially. Various reasons will induce the happening of plantar fasciitis including native bone structure, aging, athletic motions and injuries. Indeed, diagnosis of chronic heel pain remains challenging due to the complex structures of the foot. Therefore, it is widely accepted that diagnostic imaging such as ultrasound and computed tomography offer important orthopedic information for clinical assessments of soft tissues and bone. Even though there is no single treatment shows the highest level of evidence for plantar fasciitis, wearing of insoles or orthotics are highly suggested for clinical therapy. Common custom-made insoles are manufactured with polymeric materials based on standing foot-pressure distribution. However, this method strongly depends on experience of doctors or physical therapists and usually time-consuming. In addition, modern medical researches tend to combine the information of both soft (pressure distribution) and hard (orthopedic) tissues for designing of orthotics and other medical assistive devices because of the complicity of the limb motion and structures. Therefore, investigators aim at developing integrated 3D system that provides a 3D limb data model with high-resolution appearance scanning and orthopedic information for designing of medical assistant devices. This model composes of 3D surface scanning, 3D bony structure scanning, and soft tissues characteristic mechanical properties. By developing this system, the 3D model is also highly applicable to the other parts of human assistant devices. It will bring the enormous impact to the associated medical field and create excellent economic value.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• 20-80 years old

• Plantar fasciitis patients recommended to use shoe-padding orthotics for treatment

Exclusion Criteria:

• Plantar fasciitis caused by specific reasons, eg. trauma, bone spur, Acute Bursitis.

• Not Taiwanese

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis of Both Feet

Locations

Country	Name	City	State
Taiwan	NTUH East Campus, Research building, Room 946	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	The Industrial Technology Research Institute

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Design customized shoe-padding orthotics for plantar fasciitis	Combine the information of soft (pressure distribution) , hard (orthopedic) tissues and bone (CT) for designing of orthotics	3 months