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Micronized dHACM Injectable for the Treatment of Plantar Fasciitis

Sponsor
MiMedx Group, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02427191
Collaborator
(none)
147
Enrollment
11
Locations
2
Arms
40
Actual Duration (Months)
13.4
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective, single-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
  • Other: AmnioFix® Injectable
  • Drug: Saline Injection
 Phase 2/Phase 3

Detailed Description

Approximately 146 patients will be enrolled in this study. Each patient will receive 1 injection and be evaluated for efficacy and safety during a 12-month observation period. The study is expected to be completed within 36 months, inclusive of enrollment and follow-up of all subjects.

Study Design

Study Type:
Interventional
Actual Enrollment :
147 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Prospective, Single-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to the Saline Placebo Injection in the Treatment of Plantar Fasciitis
Actual Study Start Date :
Mar 31, 2015
Actual Primary Completion Date :
Aug 1, 2018
Actual Study Completion Date :
Aug 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: AmnioFix® Injectable

1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)

Other: AmnioFix® Injectable
1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)
Other Names:
  • 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 20% improvement over baseline Visual Analog Scale for Pain [3 Months]

      Visual Analog Scale

    2. Incidence of adverse events [12 months]

      Review AE at every visit

    Secondary Outcome Measures

    1. 20% improvement in Foot Function Index-Revised (FFI-R) score from baseline [3 months]

      Foot Function Index

    2. Blood sample analysis for immuno-compatibility of first 20 patients in each treatment arm [3 and 12 months]

      Lab blood draws

    3. Long-term FFI-R outcomes [6 and 12 months]

      Foot Function Index

    4. Long-term Visual Analog Scale (VAS) Pain outcomes [6 and 12 months]

      Visual Analog Scale

    5. Long-term blood sample analysis for immuno-compatibility of first 20 patients in each treatment arm [6 and 12 months]

      Lab blood draws

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. Diagnostic X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities

    2. BMI ≤ 40 kg/m2

    3. Age ≥ 21 years and < 80

    4. Ability to sign Informed Consent and Release of Medical Information Forms

    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 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

    1. Affected site exhibits clinical signs and symptoms of infection

    2. Known allergy or known sensitivity to Aminoglycosides, such as Gentamicin sulfate or Streptomycin sulfate

    3. Clinically significant abnormal laboratory tests at baseline, including CBC, PT/PTT/INR, liver function and creatinine, as determined by the investigator

    4. Patients who are non-ambulatory

    5. 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

    6. Prior radiation at the site

    7. Use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment

    8. Immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV)

    9. 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

    10. 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)

    11. Workers' compensation patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Southern Arizona VA Health Care System Tucson Arizona United States 85723
    2 Limb Preservation Platform, Inc. Fresno California United States 93721
    3 Center for Clinical Research, Inc. San Francisco California United States 94115
    4 Orlando VA Healthcare System Orlando Florida United States 32803
    5 Edward Hines Jr. Veterans Administration Hospital Chicago Illinois United States 60141
    6 James A. Lovell Federal Health Care Center North Chicago Illinois United States 60064
    7 Timonium Foot and Ankle Center Baltimore Maryland United States 21093
    8 MedStar Union Memorial Hospital Baltimore Maryland United States 21218
    9 WJB Dorn VA Medical Center Columbia South Carolina United States 29209
    10 Scott & White Healthcare Temple Texas United States 76508
    11 Coastal Podiatry Group Virginia Beach Virginia United States 23464

    Sponsors and Collaborators

    • MiMedx Group, Inc.

    Investigators

    • Principal Investigator: Stuart D Miller, MD, MedStar Union Memorial Hospital, Baltimore, MD

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MiMedx Group, Inc.
    ClinicalTrials.gov Identifier:
    NCT02427191
    Other Study ID Numbers:
    • AIPF004
    First Posted:
    Apr 27, 2015
    Last Update Posted:
    Nov 17, 2020
    Last Verified:
    Nov 1, 2020
    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:
    Fasciitis
    Fasciitis, Plantar

    Study Results

    No Results Posted as of Nov 17, 2020