Comparative Study of Amniotic Membrane Injectable in the Treatment of Recalcitrant Plantar Fasciitis
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ClinicalTrials.gov Identifier: NCT01659827 |
Recruitment Status :
Completed
First Posted : August 8, 2012
Last Update Posted : December 11, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Plantar Fasciitis | Other: Marcaine Other: 0.5cc AmnioFix Other: 1.25cc AmnioFix Other: Saline | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 45 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Randomized, Blinded, Comparative Study of Amniotic Membrane Injectable in the Treatment of Recalcitrant Plantar Fasciitis |
Study Start Date : | September 2012 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | March 2013 |
Arm | Intervention/treatment |
---|---|
Sham Comparator: Control
Initial injections of Marcaine and Saline (one each)
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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 |
- Change from Baseline in American Orthopaedic Foot and Ankle Society (AOFAS) Hind Foot Score at 8 Weeks [ Time Frame: 8 Weeks ]
- Time to return to normal activities [ Time Frame: Up to 8 Weeks ]
- Pain scale [ Time Frame: Weekly up to 8 Weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- At least 18 years old.
- Both male and female patients will be selected.
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Plantar fasciitis has been treated with conservative usual care for at least 8 weeks, including at least three of the following modalities
- RICE
- Corticosteroid injection
- Stretching exercises
- NSAIDs
- Orthotics
- Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
- Patient understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
- Patient has read and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.
Exclusion Criteria:
- Prior surgery at the site
- Site that exhibits clinical signs and symptoms of infection
- History of chronic plantar fasciitis of more than twelve months
- Evidence of significant neurological disease of the feet
- Non Ambulatory Patients
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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
- 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.
- Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding Screening.
- History of radiation at the site.
- Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
- Study foot has been previously treated with tissue engineered materials such as PRP within the last 30 days.
- Patients who are unable to understand the aims and objectives of the trial.
- 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.
- Pregnant or breast feeding. No pregnancy within the past 6 months.
- Allergy to Gentamycin Streptomycin

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659827
United States, Virginia | |
Professional Education and Research Institute | |
Roanoke, Virginia, United States, 24016 | |
Professional Education and Research Institute | |
Salem, Virginia, United States, 24153 |
Principal Investigator: | Charles M. Zelen, DPM | Professional Education and Research Institute |
Responsible Party: | MiMedx Group, Inc. |
ClinicalTrials.gov Identifier: | NCT01659827 |
Other Study ID Numbers: |
AIPF001 |
First Posted: | August 8, 2012 Key Record Dates |
Last Update Posted: | December 11, 2013 |
Last Verified: | December 2013 |
Fasciitis Fasciitis, Plantar Musculoskeletal Diseases Foot Diseases Bupivacaine Anesthetics, Local |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |