Plantar FasciitisNCT01659827
Comparative Study of Amniotic Membrane Injectable in the Treatment of Recalcitrant Plantar Fasciitis
A study testing Marcaine, 0.5cc AmnioFix and 1.25cc AmnioFix in people with Plantar Fasciitis, run by MiMedx Group, Inc. at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Marcaine, 0.5cc AmnioFix and 1.25cc AmnioFix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old.
- Both male and female patients will be selected.
- 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
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- 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.
Who cannot join
- 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
- The presence of comorbidities that can be confused with or can exacerbate the condition including:
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Professional Education and Research Institute
Roanoke, Virginia, 24016
Professional Education and Research Institute
Salem, Virginia, 24153
About this study
Official title: A Prospective, Randomized, Blinded, Comparative Study of Amniotic Membrane Injectable in the Treatment of Recalcitrant Plantar Fasciitis
The purpose of this study is to determine whether the AmnioFix Injectable human amniotic membrane is effective in the treatment of recalcitrant plantar fasciitis.
- Conditions
- Plantar Fasciitis
- Being tested
- Marcaine, 0.5cc AmnioFix, 1.25cc AmnioFix, Saline
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MarcaineOther
Injection of 2cc of Marcaine
0.5cc AmnioFixOther
Injection of 0.5cc of AmnioFix Injectable
1.25cc AmnioFixOther
Injection of 1.25cc of AmnioFix Injectable
SalineOther
Injection of 1.25cc of Saline
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Initial injections of Marcaine and Saline (one each) Receives: Other: Marcaine; Other: Saline |
| 0.5cc AmnioFix Injectable | Experimental | Initial injections of Marcaine and 0.5cc AmnioFix (one each) Receives: Other: Marcaine; Other: 0.5cc AmnioFix |
| 1.25cc AmnioFix Injectable | Experimental | Initial injections of Marcaine and 1.25cc AmnioFix (one each) Receives: Other: Marcaine; Other: 1.25cc AmnioFix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in American Orthopaedic Foot and Ankle Society (AOFAS) Hind Foot Score at 8 Weeks
Measured: 8 Weeks
Secondary outcomes (2)
Time to return to normal activities
Measured: Up to 8 Weeks
Pain scale
Measured: Weekly up to 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles M. Zelen, DPM, Principal investigator, Professional Education and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659827
- Sponsor's protocol ID
- AIPF001
- Status last verified
- Dec 2013
- First submitted
- 2 Aug 2012
- Last updated
- 11 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Blinded, Comparative Study of Amniotic Membrane Injectable in the Treatment of Recalcitrant Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT01659827
- Acronym / sponsor ID
- AIPF001
- Conditions
- Plantar Fasciitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the AmnioFix Injectable human amniotic membrane is effective in the treatment of recalcitrant plantar fasciitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: Marcaine, Other: SalineInitial injections of Marcaine and Saline (one each) |
| 0.5cc AmnioFix Injectable | Experimental | Other: Marcaine, Other: 0.5cc AmnioFixInitial injections of Marcaine and 0.5cc AmnioFix (one each) |
| 1.25cc AmnioFix Injectable | Experimental | Other: Marcaine, Other: 1.25cc AmnioFixInitial injections of Marcaine and 1.25cc AmnioFix (one each) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- At least 18 years old.
- Both male and female patients will be selected.
- Plantar fasciitis has been treated with conservative usual care for at least 8 weeks, including at least three of the following modalities
- 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.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MarcaineInjection of 2cc of Marcaine | Other | 0.5cc AmnioFix Injectable, 1.25cc AmnioFix Injectable, Control |
| 0.5cc AmnioFixInjection of 0.5cc of AmnioFix Injectable | Other | 0.5cc AmnioFix Injectable |
| 1.25cc AmnioFixInjection of 1.25cc of AmnioFix Injectable | Other | 1.25cc AmnioFix Injectable |
| SalineInjection of 1.25cc of Saline | Other | Control |
Primary outcome
Change from Baseline in American Orthopaedic Foot and Ankle Society (AOFAS) Hind Foot Score at 8 Weeks
Time frame: 8 Weeks
2 secondary outcomes
Time to return to normal activities
Time frame: Up to 8 Weeks
Pain scale
Time frame: Weekly up to 8 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles M. Zelen, DPM principal investigator
Professional Education and Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marcaine, 0.5cc AmnioFix and 1.25cc AmnioFix in people with Plantar Fasciitis, run by MiMedx Group, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in American Orthopaedic Foot and Ankle Society (AOFAS) Hind Foot Score at 8 Weeks (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013.