Arthropathy of Ankle or Foot
Conditions
Brief summary
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.
Detailed 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.
Interventions
DEVICEcustom foot orthotic
The goal of this study is to find out whether the use of software generated custom-made orthopedic foot orthoses improves pain in the long term.
Sponsors
Soleit
University of California, Davis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Each participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Patient Use of a 3D Printed Custom Foot Orthotic | 11 months | 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 pathology. Secondary: 1. To determine whether custom-made foot orthoses generate a significant increase in comfort among individuals with foot pain and/or pathology. 2. To determine whether custom-made foot orthoses improve quality of life among individuals with foot pain and/or pathology |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open Each participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted.
custom foot orthotic: The goal of this study is to find out whether the use of software generated custom-made orthopedic foot orthoses improves pain in the long term. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Open |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants |
| Age, Continuous | 45 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 60 Participants |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Successful Patient Use of a 3D Printed Custom Foot Orthotic
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 pathology. Secondary: 1. To determine whether custom-made foot orthoses generate a significant increase in comfort among individuals with foot pain and/or pathology. 2. To determine whether custom-made foot orthoses improve quality of life among individuals with foot pain and/or pathology
Time frame: 11 months
Population: A random sampling of subjects presenting with the condition being studied
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Open | Successful Patient Use of a 3D Printed Custom Foot Orthotic | 60 participants |