Plantar Fasciitis
Conditions
Keywords
plantar fasciitis
Brief summary
This is a prospective, controlled, randomized, blinded and comparative, single-center clinical trial comparing the improvement of patients with recalcitrant plantar fasciitis symptoms that have received standard of care versus treatment with differing amounts of injectable dehydrated human amnion/chorion membrane micrografts(dHACM).
Interventions
PROCEDUREInjection of 1.0 cc of 0.9% Saline
Injection of 1.0 cc of 0.9% Saline into affected area
PROCEDUREInjection of 1.0 cc of 10 mg/ml micrograft dHACM suspension
Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension into affected area
PROCEDUREInjection of 1.0 cc of 20 mg/ml micrograft dHACM suspension
Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension into affected area
PROCEDUREInjection of 1.0 cc of 40 mg/ml micrograft dHACM suspension
Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension into affected area
Sponsors
MiMedx Group, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Rest, Ice, Compression, Elevation (RICE) * Corticosteroid injection * Stretching exercises * Non-steroidal Anti-Inflammatory Drugs (NSAIDs) * 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's Nerve Entrapment or Tarsal Tunnel Syndrome) * Plantar fascial rupture * Systemic disorders associated with enthesiopathy (such as Gout, Reiter's syndrome, rheumatoid arthritis, etc.) * Achilles tendonitis * Fat pad atrophy * Fibromyalgia * Diabetics with neuropathy 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 therapy 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 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 Gentamicin and/or Streptomycin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of inflammation as measured by AOFAS Hindfoot scores | 8 Weeks | The primary objective of this study is to compare the efficacy of the different treatment amounts in reduction of inflammation as measured by AOFAS Hindfoot scores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Return to normal activities more quickly than with standard of care | 8 Weeks | The secondary objective is to demonstrate that patients treated with micronized dHACM injectable will return to normal activities more quickly than with standard of care. |
| Pain as measured by 0-10 Numeric Rating Scale | 12 weeks | Patient pain scores will be assessed between all groups. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life as measured by SF-36 | 8 weeks | SF-36 scores between all groups before and after treatment over a period of eight weeks. Physical Component Score (PCS) and Mental Component Score (MCS) will be evaluation at 8 weeks and compared to baseline |
Countries
United States
Outcome results
None listed