Validation of a Novel Foot Offloading Device (PopSole2)

Jeffrey A. Gusenoff, MD

Status: Completed

Conditions: Fat Pad Syndrome; Heel Pain Syndrome; Plantar Fasciitis, Chronic

Treatments: Device: PopSole™ Offloading Device

Study type: Interventional

Funder types: Other

Identifiers

NCT04378270

STUDY20010059

Details and patient eligibility

About

Pressure offloading is often considered the most crucial aspect in healing after a foot injury. The investigators have devised a novel foot offloading device (PopSole™) which will allow for customization of the area where there is foot pain, as well as allow for customizable arch support and elevation of the metatarsals. This validation study is aimed to assess improvement of pain with use, ease of use, fit and feel, compliance, and durability over a 4 week period. Validated patient reported outcome measures will be used at baseline, 2 weeks and 4 weeks.

Full description

All subjects will receive the PopSole™ offloading device at the screening/baseline visit, be asked to wear it for 4 weeks, and will be asked to return for an in-person evaluation at week 2 and a completion study visit at week 4.

Screening includes the following procedures:

1. Performance of a limited physical exam, inclusive of participant's foot exam with a gait and shoe gear evaluation.
2. Medical and surgical history collection
3. Vital signs, medication profile, allergies, height, weight, and BMI calculation.
4. Collection of demographic information
5. 2D Photographs of both feet will be performed

Subjects will be asked to complete:

1. Questionnaires

   • Foot and Ankle Ability Measure questionnaire
   • Mayo Clinical Scoring System questionnaire
   • American Orthopaedic Foot and Ankle Society questionnaire
   • Manchester Foot and Ankle Disability Index
   • Pittsburgh Foot Survey

2. Diary cards to document for the feet: pain, bruising, redness of the skin, itching, swelling, bleeding, and any concerns/issues not listed, as well as the location, date and day for each noted symptom.

3. Offload Device Distribution. Devices will be provided for both feet to maintain symmetry and gait stability between the two feet. One pair of devices will be given for use in shoe gear, and one pair will be given for use in a slide in the shower.

Follow up visit procedures:

Week 2

1. Collection of vital signs, medication profile, weight, and BMI calculation
2. Limited physical exam with a foot exam
3. Adverse Event Reporting
4. Collection and distribution of feet diary cards
5. 2D Photographs of both feet
6. Foot Assessment Questionnaires
7. Device survey - questions about the fit and feel of the device

Week 4

The same procedures listed for week 2, with the addition of PopSole™ Device removal and final foot diary card collection.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18 years or older and able to provide informed consent
2. Subjects with foot pain due to forefoot or heel fat pad atrophy or chronic plantar fasciitis as defined by heel pain for greater than 6 months and failed non-surgical therapy
3. Willing and able to comply with follow up examinations

Exclusion criteria

1. Concurrent injury to the lower extremity that would effect gait
2. Open foot ulcerations, fractures, or diagnosis of osteomyelitis of the feet
3. Surgical foot intervention in the last 6 months
4. Diagnosis of pregnancy or the intent of the participant to become pregnant during participation in this study
5. Neuropathy
6. Any issue that per the physician's determination would render the patient not appropriate to continue participation in the study (compliance, change in physical status, etc.)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

PopSole™ offloading device

Experimental group

Description:

This is an external insole device that fits into a shoe and is reusable for a given subject, not for one-time use. It is comparable to other off-the-shelf insoles readily available and presents minimal risk to the participant during the four weeks of study participation.

Treatment:

Device: PopSole™ Offloading Device