Evaluation of Software Generated Customized Foot Orthoses

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)

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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