Validation of a Novel Foot Offloading Device
CompletedNot applicableNCT04378270
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Validation of a Novel Foot Offloading Device
- Conditions
- Plantar Fasciitis, Chronic
- Heel Pain Syndrome
- Fat Pad Syndrome
- Interventions
- Device: PopSole™ Offloading Device
- Sponsor
- Jeffrey A. Gusenoff, MD
- Organization
- University of Pittsburgh
- Start date
- 2020-08-26
- Primary completion
- 2021-10-20
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04378270