N/A
N=20
Validation of a Novel Foot Offloading Device
Plantar Fasciitis, Chronic · Heel Pain Syndrome · Fat Pad Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04378270 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Change in Foot Pain From Screening/Baseline Visit to 4 Week Visit as Reported on the Pittsburgh Foot Survey. — 2.930 Score on a scale — p=0.0796
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PopSole™ Offloading Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jeffrey A. Gusenoff, MD
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Foot Pain From Screening/Baseline Visit to 4 Week Visit as Reported on the Pittsburgh Foot Survey. |
2.930 | 0.0796 |
| PRIMARY Change in Foot Pain From Screening/Baseline Visit to 4 Week Visit as Reported on the Manchester Foot and Ankle Index. |
-1.7 | 0.0634 |
| PRIMARY Change in Foot Pain From Screening/Baseline Visit to 4 Week Visit as Reported on the Mayo Clinical Scoring System Questionnaire. |
18.7 | 0.0020 sig |
| PRIMARY Change in Foot Pain From Screening/Baseline Visit to 4 Week Visit as Reported on the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale. |
16.67 | 0.0006 sig |
| PRIMARY Device Durability |
15 | — |
| PRIMARY Participant Compliance With Device |
4 | — |
| SECONDARY Participants' Reported Satisfaction and/or Difficulties With the Device |
17.87 | 0.0001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Aged 18 years or older and able to provide informed consent
- 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
- Willing and able to comply with follow up examinations
Exclusion Criteria
- Concurrent injury to the lower extremity that would effect gait
- Open foot ulcerations, fractures, or diagnosis of osteomyelitis of the feet
- Surgical foot intervention in the last 6 months
- Diagnosis of pregnancy or the intent of the participant to become pregnant during participation in this study
- Neuropathy
- 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.)
Data sourced from ClinicalTrials.gov (NCT04378270). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.