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Active Clinical Trials

Micronized dHACM Injectable for the Treatment of Plantar Fasciitis

Active NCT:
03414268
West Penn Hospital
West Penn Hospital

Category:
Bone and Muscle
Sponsor: 
MiMedx Group, Inc.
Contact: 

For more information, please contact Kathryn Duffill by telephone at 412-688-7910 or email at Kathryn.Duffill@ahn.org .

AMINOFIX007, A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Plantar Fasciitis

Purpose: 

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

Ages Eligible for Study:  21 Years to 79 Years   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

Inclusion Criteria:

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 Criteria:

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