Comparative Study of Amniotic Membrane Injectable in the Treatment of Recalcitrant Plantar Fasciitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.
ClinicalTrials.gov Identifier:
NCT01659827
First received: August 2, 2012
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Plantar Fasciitis
Other: Marcaine
Other: 0.5cc AmnioFix
Other: 1.25cc AmnioFix
Other: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Blinded, Comparative Study of Amniotic Membrane Injectable in the Treatment of Recalcitrant Plantar Fasciitis

Resource links provided by NLM:


Further study details as provided by MiMedx Group, Inc.:

Primary Outcome Measures:
  • Change from Baseline in American Orthopaedic Foot and Ankle Society (AOFAS) Hind Foot Score at 8 Weeks [ Time Frame: 8 Weeks ]

Secondary Outcome Measures:
  • Time to return to normal activities [ Time Frame: Up to 8 Weeks ]
  • Pain scale [ Time Frame: Weekly up to 8 Weeks ]

Enrollment: 45
Study Start Date: September 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Control
Initial injections of Marcaine and Saline (one each)
Other: Marcaine
Injection of 2cc of Marcaine
Other: Saline
Injection of 1.25cc of Saline
Experimental: 0.5cc AmnioFix Injectable
Initial injections of Marcaine and 0.5cc AmnioFix (one each)
Other: Marcaine
Injection of 2cc of Marcaine
Other: 0.5cc AmnioFix
Injection of 0.5cc of AmnioFix Injectable
Experimental: 1.25cc AmnioFix Injectable
Initial injections of Marcaine and 1.25cc AmnioFix (one each)
Other: Marcaine
Injection of 2cc of Marcaine
Other: 1.25cc AmnioFix
Injection of 1.25cc of AmnioFix Injectable

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. At least 18 years old.
  2. Both male and female patients will be selected.
  3. Plantar fasciitis has been treated with conservative usual care for at least 8 weeks, including at least three of the following modalities

    1. RICE
    2. Corticosteroid injection
    3. Stretching exercises
    4. NSAIDs
    5. Orthotics
  4. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
  5. Patient understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
  6. Patient has read and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.

Exclusion Criteria:

  1. Prior surgery at the site
  2. Site that exhibits clinical signs and symptoms of infection
  3. History of chronic plantar fasciitis of more than twelve months
  4. Evidence of significant neurological disease of the feet
  5. Non Ambulatory Patients
  6. 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
  7. 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.
  8. Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding Screening.
  9. History of radiation at the site.
  10. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
  11. Study foot has been previously treated with tissue engineered materials such as PRP within the last 30 days.
  12. Patients who are unable to understand the aims and objectives of the trial.
  13. Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
  14. Pregnant or breast feeding. No pregnancy within the past 6 months.
  15. Allergy to Gentamycin Streptomycin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659827

Locations
United States, Virginia
Professional Education and Research Institute
Roanoke, Virginia, United States, 24016
Professional Education and Research Institute
Salem, Virginia, United States, 24153
Sponsors and Collaborators
MiMedx Group, Inc.
Investigators
Principal Investigator: Charles M. Zelen, DPM Professional Education and Research Institute
  More Information

No publications provided

Responsible Party: MiMedx Group, Inc.
ClinicalTrials.gov Identifier: NCT01659827     History of Changes
Other Study ID Numbers: AIPF001
Study First Received: August 2, 2012
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014