Micronized dHACM Injectable for the Treatment of Plantar Fasciitis

Completed · Phase 2/Phase 3

Conditions studied: Fasciitis, Plantar

In brief

Prospective, single-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis

Key facts

Study ID

NCT02427191

Run by

MiMedx Group, Inc.

People needed

147

Starts

2015-03-31

Expected to finish

2018-08-01

Last updated by the study team

2020-11-17

Who can join

Age: 21 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Ability to sign Informed Consent and Release of Medical Information Forms

You may not qualify if…

• 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 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 (Baxter Nerve Syndrome)
• Fat pad atrophy
• Acute traumatic rupture of the plantar fascia
• Calcaneal tumor
• Tarsal tunnel syndrome
• 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, such as Gentamicin sulfate or Streptomycin sulfate
• Clinically significant abnormal laboratory tests at baseline, including CBC, PT/PTT/INR, liver function and creatinine, as determined by the investigator
• Patients 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 patients

Where it is running

• Southern Arizona VA Health Care System — Tucson, Arizona, United States
• Limb Preservation Platform, Inc. — Fresno, California, United States
• Center for Clinical Research, Inc. — San Francisco, California, United States
• Orlando VA Healthcare System — Orlando, Florida, United States
• Edward Hines Jr. Veterans Administration Hospital — Chicago, Illinois, United States
• James A. Lovell Federal Health Care Center — North Chicago, Illinois, United States
• Timonium Foot and Ankle Center — Baltimore, Maryland, United States
• MedStar Union Memorial Hospital — Baltimore, Maryland, United States
• WJB Dorn VA Medical Center — Columbia, South Carolina, United States
• Scott & White Healthcare — Temple, Texas, United States
• Coastal Podiatry Group — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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