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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01659827
Recruitment Status : Completed
First Posted : August 8, 2012
Last Update Posted : December 11, 2013
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.

Tracking Information
First Submitted Date  ICMJE August 2, 2012
First Posted Date  ICMJE August 8, 2012
Last Update Posted Date December 11, 2013
Study Start Date  ICMJE September 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2012)
Change from Baseline in American Orthopaedic Foot and Ankle Society (AOFAS) Hind Foot Score at 8 Weeks [ Time Frame: 8 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2012)
  • Time to return to normal activities [ Time Frame: Up to 8 Weeks ]
  • Pain scale [ Time Frame: Weekly up to 8 Weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Study of Amniotic Membrane Injectable in the Treatment of Recalcitrant Plantar Fasciitis
Official Title  ICMJE A Prospective, Randomized, Blinded, Comparative Study of Amniotic Membrane Injectable in the Treatment of Recalcitrant Plantar Fasciitis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Plantar Fasciitis
Intervention  ICMJE
  • Other: Marcaine
    Injection of 2cc of Marcaine
  • Other: 0.5cc AmnioFix
    Injection of 0.5cc of AmnioFix Injectable
  • Other: 1.25cc AmnioFix
    Injection of 1.25cc of AmnioFix Injectable
  • Other: Saline
    Injection of 1.25cc of Saline
Study Arms  ICMJE
  • Sham Comparator: Control
    Initial injections of Marcaine and Saline (one each)
    Interventions:
    • Other: Marcaine
    • Other: Saline
  • Experimental: 0.5cc AmnioFix Injectable
    Initial injections of Marcaine and 0.5cc AmnioFix (one each)
    Interventions:
    • Other: Marcaine
    • Other: 0.5cc AmnioFix
  • Experimental: 1.25cc AmnioFix Injectable
    Initial injections of Marcaine and 1.25cc AmnioFix (one each)
    Interventions:
    • Other: Marcaine
    • Other: 1.25cc AmnioFix
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2012)
45
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01659827
Other Study ID Numbers  ICMJE AIPF001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party MiMedx Group, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE MiMedx Group, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Charles M. Zelen, DPM Professional Education and Research Institute
PRS Account MiMedx Group, Inc.
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP