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Micronized dHACM Injectable for the Treatment of Plantar Fasciitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03414268
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.

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

Condition or disease Intervention/treatment Phase
Fasciitis, Plantar Other: Micronized dHACM Drug: Saline Injection Phase 3

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. The study is expected to be completed within 34 months, inclusive of enrollment and follow-up of all subjects.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Micronized dHACM
1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)
Other: Micronized dHACM
1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)
Other Name: dHACM

Placebo Comparator: Saline Injection
Injection of 1mL 0.9% Sodium Chloride Injection, USP
Drug: Saline Injection
Injection of 1mL 0.9% Sodium Chloride Injection, USP
Other Names:
  • 0.9% NaCl
  • Normal Saline
  • Sodium Chloride Injection, USP




Primary Outcome Measures :
  1. Change in VAS score [ Time Frame: 90 Days ]
    Visual Analog Scale for Pain:

  2. Incidence of adverse events [ Time Frame: 180 Days ]
    The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events during the first 12 months post injection


Secondary Outcome Measures :
  1. Foot Function Index - Revised (FFI-R) (Short Form) [ Time Frame: 90 Days ]
    Foot Function Index - Revised: Patient Reported Questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Confirmed diagnosis of plantar fasciitis for ≥ 1 month (30 days) and ≤ 18 months by the investigator
  2. VAS Pain scale of ≥ 45 mm at randomization
  3. Plantar fasciitis with conservative treatment for ≥ 1 month (30 days), including any of the following modalities:

    • RICE
    • Stretching exercises
    • NSAIDs
    • Orthotics
  4. Diagnostic X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities
  5. BMI ≤ 40 kg/m2
  6. Age ≥ 21 years and < 80 years
  7. Ability to sign Informed Consent and Release of Medical Information Forms
  8. Ability to receive and respond to text messages or emails on a daily basis.

Exclusion Criteria:

  1. Prior surgery or trauma to the affected site
  2. Subjects requiring bilateral plantar fasciitis treatment at time of enrollment
  3. Prior use of any lower limb injection therapy, including corticosteroids or PRP in either limb within the last 3 months
  4. Has diabetes either Type I or Type II.
  5. Systemic disorders associated with enthesopathy (disorder of entheses, i.e. bone attachments) such as Gout, Reiter's syndrome, rheumatoid arthritis, etc.
  6. 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
  7. Affected site exhibits clinical signs and symptoms of infection
  8. Known allergy or known sensitivity to Aminoglycosides
  9. Subjects who are non-ambulatory
  10. 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
  11. Prior radiation at the site
  12. Use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment
  13. Immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV)
  14. 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
  15. 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)
  16. Workers' compensation subjects

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414268


Contacts
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Contact: Mary Kate Pynes 770-651-9100 mpynes@mimedx.com
Contact: David Mason, MD 770-651-9293 dmason@mimedx.com

Locations
Show Show 19 study locations
Sponsors and Collaborators
MiMedx Group, Inc.
Investigators
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Principal Investigator: Stuart D Miller, MD MedStar Union Memorial Hospital, Baltimore, MD
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Responsible Party: MiMedx Group, Inc.
ClinicalTrials.gov Identifier: NCT03414268    
Other Study ID Numbers: AIPF007
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MiMedx Group, Inc.:
Chronic plantar fasciitis
Heel pain
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases