Clinical trial NCT01659827: Comparative Study of Amniotic Membrane Injectable in the Treatment of Recalcitrant Plantar Fasciitis
Official title: A Prospective, Randomized, Blinded, Comparative Study of Amniotic Membrane Injectable in the Treatment of Recalcitrant Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fasciitis
Lead sponsor: MiMedx Group, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from Baseline in American Orthopaedic Foot and Ankle Society (AOFAS) Hind Foot Score at 8 Weeks
timeFrame: 8 Weeks
Secondary outcomes:
measure: Time to return to normal activities
timeFrame: Up to 8 Weeks
measure: Pain scale
timeFrame: Weekly up to 8 Weeks
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Professional Education and Research Institute
state: Virginia
city: Salem
country: United States
facility: Professional Education and Research Institute
state: Virginia
Study officials:
affiliation: Professional Education and Research Institute
name: Charles M. Zelen, DPM
role: PRINCIPAL_INVESTIGATOR
References: