NCT01659827

Brief Summary

The purpose of this study is to determine whether the AmnioFix Injectable human amniotic membrane is effective in the treatment of recalcitrant plantar fasciitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 8, 2012

Completed
24 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

6 months

First QC Date

August 2, 2012

Last Update Submit

December 10, 2013

Conditions

Plantar Fasciitis

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in American Orthopaedic Foot and Ankle Society (AOFAS) Hind Foot Score at 8 Weeks

    8 Weeks

Secondary Outcomes (2)

  • Time to return to normal activities

    Up to 8 Weeks

  • Pain scale

    Weekly up to 8 Weeks

Study Arms (3)

Control

SHAM COMPARATOR

Initial injections of Marcaine and Saline (one each)

Other: MarcaineOther: Saline

0.5cc AmnioFix Injectable

EXPERIMENTAL

Initial injections of Marcaine and 0.5cc AmnioFix (one each)

Other: MarcaineOther: 0.5cc AmnioFix

1.25cc AmnioFix Injectable

EXPERIMENTAL

Initial injections of Marcaine and 1.25cc AmnioFix (one each)

Other: MarcaineOther: 1.25cc AmnioFix

Interventions

MarcaineOTHER

Injection of 2cc of Marcaine

0.5cc AmnioFix Injectable1.25cc AmnioFix InjectableControl
0.5cc AmnioFixOTHER

Injection of 0.5cc of AmnioFix Injectable

0.5cc AmnioFix Injectable
1.25cc AmnioFixOTHER

Injection of 1.25cc of AmnioFix Injectable

1.25cc AmnioFix Injectable
SalineOTHER

Injection of 1.25cc of Saline

Control

Eligibility Criteria

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

You may qualify if:

  • At least 18 years old.
  • Both male and female patients will be selected.
  • Plantar fasciitis has been treated with conservative usual care for at least 8 weeks, including at least three of the following modalities
  • RICE
  • Corticosteroid injection
  • Stretching exercises
  • NSAIDs
  • Orthotics
  • Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
  • Patient understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
  • Patient has read and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.

You may not qualify if:

  • Prior surgery at the site
  • Site that exhibits clinical signs and symptoms of infection
  • History of chronic plantar fasciitis of more than twelve months
  • Evidence of significant neurological disease of the feet
  • Non Ambulatory Patients
  • The presence of comorbidities that can be confused with or can exacerbate the condition including:
  • Calcaneal stress fracture
  • Nerve entrapment syndrome (baxter nerve syndrome or tarsal tunnel)
  • Plantar fascial rupture
  • Systemic disorders associated with enthesiopathy such as Gout, Reiters syndrome, rheumatoid arthritis, etc.
  • Achilles tendonitis
  • Fat pad atrophy
  • Fibromyalgia
  • Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
  • Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding Screening.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Professional Education and Research Institute

Roanoke, Virginia, 24016, United States

Location

Professional Education and Research Institute

Salem, Virginia, 24153, United States

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

BupivacaineSodium Chloride

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Charles M. Zelen, DPM

    Professional Education and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 2, 2012

First Posted

August 8, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

US(2)