Comparative Study of Amniotic Membrane Injectable in the Treatment of Recalcitrant Plantar Fasciitis
NCT ID: NCT01659827
Last Updated: 2013-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
45 participants
INTERVENTIONAL
2012-09-30
2013-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
Initial injections of Marcaine and Saline (one each)
Marcaine
Injection of 2cc of Marcaine
Saline
Injection of 1.25cc of Saline
0.5cc AmnioFix Injectable
Initial injections of Marcaine and 0.5cc AmnioFix (one each)
Marcaine
Injection of 2cc of Marcaine
0.5cc AmnioFix
Injection of 0.5cc of AmnioFix Injectable
1.25cc AmnioFix Injectable
Initial injections of Marcaine and 1.25cc AmnioFix (one each)
Marcaine
Injection of 2cc of Marcaine
1.25cc AmnioFix
Injection of 1.25cc of AmnioFix Injectable
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MiMedx Group, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Charles M. Zelen, DPM
Role: PRINCIPAL_INVESTIGATOR
Professional Education and Research Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Professional Education and Research Institute
Roanoke, Virginia, United States
Professional Education and Research Institute
Salem, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AIPF001
Identifier Type: -
Identifier Source: org_study_id