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

Status: Unknown
Location: See all (6) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Ages 18 to 75 inclusive

• BMI less than 40

• Actively practicing a contraception method, abstinent, surgically sterile, or post-menopausal (defined as no menses for a minimum of 12 months)

• Reporting heel pain of \>6 on a verbally administered 1-10 pain scale where 1 is no pain and 10 is extreme pain

• Diagnosed with plantar fasciitis in either foot

• Completed a minimum of two months of conservative, non-injection treatment/therapies (i.e., activity modification, icing, NSAIDs, orthotics, physical therapy, etc.)

Locations
United States
Colorado
Advanced Orthopedics
Denver
Florida
Orlando Food and Ankle Clinic
Orlando
Iowa
The Iowa Clinic Foot and Ankle Surgery
West Des Moines
Ohio
Lower Extremity Institute of Research & Therapy (LEIRT)
Poland
Pennsylvania
Geisinger
Danville
Washington
The Vancouvover Clinic
Vancouver
Time Frame
Start Date: 2016-09
Completion Date: 2021-04
Participants
Target number of participants: 150
Treatments
Experimental: ReNu Injection
Plantar Fascia injection with ReNu. ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.
Active_comparator: Corticosteroid Injection
Plantar Fascia injection with Corticosteroids.
Related Therapeutic Areas
Sponsors
Collaborators: MileStone Research Organization, Organogenesis
Leads: NuTech Medical, Inc

This content was sourced from clinicaltrials.gov

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