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

A Prospective, Randomized, Blinded, Comparative Study of Amniotic Membrane Injectable in the Treatment of Recalcitrant Plantar Fasciitis

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

Study Overview

• Status: Completed
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Other: Marcaine; Other: Saline; Other: 0.5cc AmnioFix; Other: 1.25cc AmnioFix

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Professional Education and Research Institute
    • Salem, Virginia, United States, 24153
      • Professional Education and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in American Orthopaedic Foot and Ankle Society (AOFAS) Hind Foot Score at 8 Weeks	8 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to return to normal activities	Up to 8 Weeks
Pain scale	Weekly up to 8 Weeks

Collaborators and Investigators

• Sponsor: MiMedx Group, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: August 2, 2012
• First Submitted That Met QC Criteria: August 7, 2012
• First Posted (Estimate): August 8, 2012

Study Record Updates

• Last Update Posted (Estimate): December 11, 2013
• Last Update Submitted That Met QC Criteria: December 10, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: AIPF001