NCT02982226

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

4.6 years

First QC Date

November 29, 2016

Last Update Submit

April 17, 2020

Conditions

Fasciitis, Plantar

Keywords

Plantar FasciitisJogger's HeelReNu

Outcome Measures

Primary Outcomes (1)

  • Change in AOFAS score from baseline

    6 months

Secondary Outcomes (3)

  • Change in VAS pain score from baseline

    6 months

  • Change in SANE function score from baseline

    6 months

  • Return to Normal Function between treatment groups

    6 months

Study Arms (2)

ReNu Injection

EXPERIMENTAL

Plantar Fascia injection with ReNu. ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.

Other: ReNu Injection

Corticosteroid Injection

ACTIVE COMPARATOR

Plantar Fascia injection with Corticosteroids.

Other: Corticosteroid Injection

Interventions

ReNu InjectionOTHER

ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.

ReNu Injection
Corticosteroid InjectionOTHER

Corticosteroids are considered a standard of care for treatment of Plantar Fasciitis

Corticosteroid Injection

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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:
  • Calcaneal stress fracture
  • Nerve entrapment syndrome, such as Baxter's Nerve Entrapment or Tarsal Tunnel Syndrome
  • Plantar Fascial rupture
  • Systemic disorders associated with enthesiopathy, i.e., Gout, Reiter's syndrome, rheumatoid arthritis, etc.
  • Achilles tendonitis
  • Fat Pad Atrophy
  • Fibromyalgia
  • Diabetic Neuropathy
  • 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.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Advanced Orthopedics

Denver, Colorado, 80230, United States

Location

Orlando Food and Ankle Clinic

Orlando, Florida, 32806, United States

Location

The Iowa Clinic Foot and Ankle Surgery

West Des Moines, Iowa, 50266, United States

Location

Lower Extremity Institute of Research & Therapy (LEIRT)

Poland, Ohio, 44514, United States

Location

Geisinger

Danville, Pennsylvania, United States

Location

The Vancouvover Clinic

Vancouver, Washington, 98686, United States

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Alan Ng, DPM, FACFAS

    Advanced Orthopedics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 5, 2016

Study Start

September 1, 2016

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

April 21, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(6)