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The objective of this clinical trial is to evaluate both the safety and efficacy of the ReNu™ injection on pain and inflammation in subjects diagnosed with plantar fasciitis as compared to a Corticosteroid Injection which is considered standard of care.
Full description
This is a two (2) arm evaluation in 150 subjects with plantar fasciitis. Patients will be treated with ReNu™(study treatment) or Corticosteroids (control).
At each follow-up visit, concomitant medications and adverse events shall be collected from each subject, and each subject shall complete following questionnaires:
The subjects will be assessed at Baseline (pre-injection) using these scales and again at all subsequent study follow-up visits.
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Inclusion and exclusion criteria
Inclusion Criteria:
Exclusion Criteria
Prior surgery on the affected foot
Prior injection treatment for plantar fasciitis within the past 6 months with steroids or tissue engineered materials just in the site seeking treatment
Clinical signs and symptoms of infection of foot in question
Evidence of significant neurological disease of either foot
Non-ambulatory
Presence of comorbidities that can be confused with or can exacerbate the condition including, but not limited to the following:
Pregnant, pregnant within the past six (6) months, breast feeding and/or desire to become pregnant during the course of the study, as verified by urine pregnancy test within one week prior to injection.
Has taken NSAID medication within the past 14 days, or other pain medication in the past day
History of more than two (2) weeks treatment with immuno-suppressants, including systemic corticosteroids or cytotoxic chemotherapy within one month prior to initial screening, or has receive such medications during the screening period, or are anticipated to require such medications during the course of the study.
Taking any investigational drug(s) or therapeutic device(s) within 30 days preceding screening
History of radiation therapy of the affected foot
Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
Involved in a Worker's Compensation Claim of any kind
Unable to understand the objectives of the trial
Presence of any condition(s) which, in the opinion of the investigator, would compromise the subject's ability to complete this study
Having a known history of poor adherence with medical treatment.
Express an unwillingness to receive human allograft tissue
Primary purpose
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Interventional model
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150 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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