NCT01659827
Completed
Not Applicable
A Prospective, Randomized, Blinded, Comparative Study of Amniotic Membrane Injectable in the Treatment of Recalcitrant Plantar Fasciitis
ConditionsPlantar Fasciitis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Plantar Fasciitis
- Sponsor
- MiMedx Group, Inc.
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Change from Baseline in American Orthopaedic Foot and Ankle Society (AOFAS) Hind Foot Score at 8 Weeks
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to determine whether the AmnioFix Injectable human amniotic membrane is effective in the treatment of recalcitrant plantar fasciitis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •At least 18 years old.
- •Both male and female patients will be selected.
- •Plantar fasciitis has been treated with conservative usual care for at least 8 weeks, including at least three of the following modalities
- •Corticosteroid injection
- •Stretching exercises
- •Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
- •Patient understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
- •Patient has read and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.
Exclusion Criteria
- •Prior surgery at the site
- •Site that exhibits clinical signs and symptoms of infection
- •History of chronic plantar fasciitis of more than twelve months
- •Evidence of significant neurological disease of the feet
- •Non Ambulatory Patients
- •The presence of comorbidities that can be confused with or can exacerbate the condition including:
- •Calcaneal stress fracture
- •Nerve entrapment syndrome (baxter nerve syndrome or tarsal tunnel)
- •Plantar fascial rupture
- •Systemic disorders associated with enthesiopathy such as Gout, Reiters syndrome, rheumatoid arthritis, etc.
Outcomes
Primary Outcomes
Change from Baseline in American Orthopaedic Foot and Ankle Society (AOFAS) Hind Foot Score at 8 Weeks
Time Frame: 8 Weeks
Secondary Outcomes
- Time to return to normal activities(Up to 8 Weeks)
- Pain scale(Weekly up to 8 Weeks)
Study Sites (1)
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