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

MiMedx

Status: Completed

Conditions: Plantar Fasciitis

Treatments: Other: Saline; Other: 0.5cc AmnioFix; Other: Marcaine; Other: 1.25cc AmnioFix

Study type: Interventional

Funder types: Industry

Identifiers

NCT01659827

AIPF001

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Control

Sham Comparator group

Description:

Initial injections of Marcaine and Saline (one each)

Treatment:

Other: Saline

Other: Marcaine

0.5cc AmnioFix Injectable

Experimental group

Description:

Initial injections of Marcaine and 0.5cc AmnioFix (one each)

Treatment:

Other: Marcaine

Other: 0.5cc AmnioFix

1.25cc AmnioFix Injectable

Experimental group

Description:

Initial injections of Marcaine and 1.25cc AmnioFix (one each)

Treatment:

Other: Marcaine

Other: 1.25cc AmnioFix