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

Plantar Fasciitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01659827
• Other study ID #: AIPF001
• Status: Completed
• Phase: N/A
• First received: August 2, 2012
• Last updated: December 10, 2013
• Start date: September 2012
• Est. completion date: March 2013

Study information

• Verified date: December 2013
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Other:
• Marcaine
Injection of 2cc of Marcaine
• 0.5cc AmnioFix
Injection of 0.5cc of AmnioFix Injectable
• 1.25cc AmnioFix
Injection of 1.25cc of AmnioFix Injectable
• Saline
Injection of 1.25cc of Saline

Locations

Country	Name	City	State
United States	Professional Education and Research Institute	Roanoke	Virginia
United States	Professional Education and Research Institute	Salem	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in American Orthopaedic Foot and Ankle Society (AOFAS) Hind Foot Score at 8 Weeks		8 Weeks
Secondary	Time to return to normal activities		Up to 8 Weeks
Secondary	Pain scale		Weekly up to 8 Weeks