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Evaluation of Software Generated Customized Foot Orthoses

University of California (UC) Davis logo

University of California (UC) Davis

Status

Terminated

Conditions

Arthropathy of Ankle or Foot

Treatments

Device: custom foot orthotic

Study type

Interventional

Funder types

Other

Identifiers

NCT05462912
1771535

Details and patient eligibility

About

The purpose of this study is to determine whether custom-made foot orthoses generate a significant decrease in the perception of pain among individuals with foot pain and/or ankle pain.

Full description

The investigators aim to enroll up to 60 participants over the course of 1-3 months. Each participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted. Subsequently, consecutive surveys will be carried out at 0, 7, 30, 120, and 360 days from the first day of foot orthoses use to measure the change in pain and comfort with use of the foot orthoses. An interim analysis will be conducted after all subjects have completed the 30-day time point. This interim analysis will allow the sponsor to determine whether subjects are using the foot orthoses that the subjects have been provided. Complete primary analysis is estimated to be completed within 3 months after the termination of the study.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Foot/ankle pain or pathology OR diagnosed pes planus, pes cavus, pronator foot, supinator foot, metatarsalgia, Morton's neuroma, sesamoiditis, hallux valgus, intermetatarsal bursitis
  2. Between 18 and 65 years of age
  3. BMI is greater than 18.5 or less than 30

Exclusion criteria

  1. Individuals who have had surgery in the lower limbs during this past year.
  2. Individuals who already have custom-made orthopedic orthoses.
  3. Patients with active diabetic ulcers or chronic foot pressure ulcers.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Open
Other group
Description:
Each participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted.
Treatment:
Device: custom foot orthotic

Trial contacts and locations

1

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Central trial contact

Eric Giza, MD

Data sourced from clinicaltrials.gov

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