NCT04378270

Validation of a Novel Foot Offloading Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Jeffrey A. Gusenoff, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Plantar Fasciitis, Chronic
• Heel Pain Syndrome
• Fat Pad Syndrome

Interventions

Type	Name	Description
DEVICE	PopSole™ Offloading Device	Specifically, the PopSole™ Offloading Device allows the provider to pop bubbles in the device (like popping paper or plastic bubble sheeting), thereby offloading the surgical area or area of pain. This customizable approach to offloading may increase compliance as it can easily fit in a normal walking shoe and is personalized for each patient. It can also be attached to a slide for use in the shower. Currently no post-operative devices for offloading the foot can be used in the shower.

Timeline

• Start date: 2020-08-26
• Primary completion: 2021-10-20
• Completion: 2021-10-20
• First posted: 2020-05-07
• Last updated: 2024-01-31
• Results posted: 2022-10-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study