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Clinical Trial Summary

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.


Clinical Trial 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:

- AOFAS Ankle-Hindfoot Score (AOFAS-AHS)

- Visual Analog Score (VAS)

- Single Answer Numeric Evaluation (SANE)

- Subject Satisfaction Score (at the 6 Month Follow Ups ONLY)

The subjects will be assessed at Baseline (pre-injection) using these scales and again at all subsequent study follow-up visits. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02982226
Study type Interventional
Source NuTech Medical, Inc
Contact
Status Active, not recruiting
Phase N/A
Start date September 2016
Completion date April 2021

See also
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