NCT02982226

ReNu™ vs. Corticosteroids for the Treatment of Plantar Fasciitis

A Comparative Study of Injectable Human Amniotic Allograft (ReNu™) Versus Corticosteroids for Plantar Fasciitis: A Prospective, Randomized, Blinded Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: NuTech Medical, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Fasciitis, Plantar

Interventions

Type	Name	Description
OTHER	ReNu Injection	ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.
OTHER	Corticosteroid Injection	Corticosteroids are considered a standard of care for treatment of Plantar Fasciitis

Timeline

• Start date: 2016-09-01
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2016-12-05
• Last updated: 2020-04-21

Locations

6 sites across 1 country: United States