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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01659827
Other study ID # AIPF001
Secondary ID
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


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
See also
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Completed NCT00888394 - Effectiveness of Podiatry on Plantar Pain Phase 4
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Completed NCT00155324 - Change and Clinical Significance of Plantar Fascia Thickness After ESWT N/A
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Completed NCT06055933 - Effect of Kinesio Taping and Extracorporeal Shock Wave Therapy on Plantar Fasciitis
Recruiting NCT02539082 - the Safety and Efficacy of Collagen Injection in Patients With Plantar Fasciitis Phase 4
Enrolling by invitation NCT01786057 - Effect of Extracorporeal Shock Wave Therapy of Gastrosoleus Trigger Points in Patients With Plantar Fasciitis Phase 2/Phase 3
Recruiting NCT03978234 - Evaluating the Safety and Effect of abobotulinumtoxinA in the Gastrocnemius Muscle to Improve Equinus and Plantar Fasciitis Pain Phase 2