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

Not Applicable

Completed

• Conditions: Plantar Fasciitis
• Interventions: Other: Marcaine; Other: Saline; Other: 0.5cc AmnioFix; Other: 1.25cc AmnioFix

• Registration Number: NCT01659827
• Lead Sponsor: MiMedx Group, Inc.

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 available

Study Timeline

• Study First Submitted: 2012-08-02
• Study First Submitted QC: 2012-08-07
• Study First Posted: 2012-08-08
• Study Start: 2012-09
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-10
• Last Update Posted: 2013-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Marcaine	Initial injections of Marcaine and Saline (one each)
Control	Saline	Initial injections of Marcaine and Saline (one each)
0.5cc AmnioFix Injectable	Marcaine	Initial injections of Marcaine and 0.5cc AmnioFix (one each)
0.5cc AmnioFix Injectable	0.5cc AmnioFix	Initial injections of Marcaine and 0.5cc AmnioFix (one each)
1.25cc AmnioFix Injectable	Marcaine	Initial injections of Marcaine and 1.25cc AmnioFix (one each)
1.25cc AmnioFix Injectable	1.25cc AmnioFix	Initial injections of Marcaine and 1.25cc AmnioFix (one each)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to return to normal activities	Up to 8 Weeks
Pain scale	Weekly up to 8 Weeks

Trial Locations

Locations (1)

Professional Education and Research Institute; 🇺🇸 Salem, Virginia, United States