Per sponsor, trial criteria were not followed and the data collected is not available

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.

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.

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.

Subjects complaining of foot pain.

11 months after completion of screening visit.

Because this study is subjective in nature, only adverse events that are serious, unexpected, and device-related will be recorded. Collection of adverse events will begin once subject begins using the foot orthoses. All adverse events will be monitored and reported in accordance with the UC Davis Institutional Review Board (IRB) policies

Due to significant issues identified in the data collection process the study was terminated prematurely The study required participants to complete a survey at three specific time points: This was not done.

The data was not stored and will not be used for any future analysis. No data was evaluated or stored that was collected for this trial. The website where data was originally collected was deleted and not accessible. No data analysis was done.