Status:
COMPLETED
Micronized dHACM Injectable for the Treatment of Plantar Fasciitis
Lead Sponsor:
MiMedx Group, Inc.
Conditions:
Fasciitis, Plantar
Eligibility:
All Genders
21-79 years
Phase:
PHASE3
Brief Summary
Prospective, double-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis
Detailed Description
Approximately 276 patients will be enrolled in this study. Each patient will receive 1 injection and be evaluated for efficacy and safety during a 6-month observation period. Randomization will be 1:1...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of plantar fasciitis for ≥ 1 month (30 days) and ≤ 18 months by the investigator
- VAS Pain scale of ≥ 45 mm at randomization
- Plantar fasciitis with conservative treatment for ≥ 1 month (30 days), including any of the following modalities:
- RICE
- Stretching exercises
- NSAIDs
- Orthotics
- Diagnostic X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities
- BMI ≤ 40 kg/m2
- Age ≥ 21 years and \< 80 years
- Ability to sign Informed Consent and Release of Medical Information Forms
- Ability to receive and respond to text messages or emails on a daily basis.
Exclusion
- Prior surgery or trauma to the affected site
- Subjects requiring bilateral plantar fasciitis treatment at time of enrollment
- Prior use of any lower limb injection therapy, including corticosteroids or PRP in either limb within the last 3 months
- Has diabetes either Type I or Type II.
- Systemic disorders associated with enthesopathy (disorder of entheses, i.e. bone attachments) such as Gout, Reiter's syndrome, rheumatoid arthritis, etc.
- The presence of diagnosed comorbidities that can be confused with or can exacerbate the condition- to be assessed by X-ray - including but not limited to:
- Calcaneal stress fracture
- Nerve entrapment syndrome (diagnosed as Baxter Nerve Syndrome)
- Fat pad atrophy
- Acute traumatic rupture of the plantar fascia
- Calcaneal tumor
- Tarsal tunnel syndrome (diagnosed)
- Significant bone deformity of the foot that may interfere with the study
- Affected site exhibits clinical signs and symptoms of infection
- Known allergy or known sensitivity to Aminoglycosides
- Subjects who are non-ambulatory
- History of more than 14 days treatment with immuno-suppressants (including systemic corticosteroids) or cytotoxic chemotherapy within 30 days prior to enrollment, or who are anticipated to require such medications during the course of the study
- Prior radiation at the site
- Use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment
- Immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV)
- History of any condition (including drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol, in the judgment of the investigator
- Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)
- Workers' compensation subjects
Key Trial Info
Start Date :
January 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2021
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT03414268
Start Date
January 8 2018
End Date
March 17 2021
Last Update
May 19 2022
Active Locations (17)
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1
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
2
ILD Research Center
Carlsbad, California, United States, 92009
3
Center for Clinical Research
Carmichael, California, United States, 95608
4
Limb Preservation Platform, Inc.
Fresno, California, United States, 93721