Micronized dHACM Injectable for the Treatment of Plantar Fasciitis (dHACM)

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

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

Study Overview

• Status: Completed
• Conditions: Fasciitis, Plantar
• Intervention / Treatment: Other: AmnioFix® Injectable; Drug: Saline Injection

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 Type: Interventional
• Enrollment (Actual): 147
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
7. 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
7. Affected site exhibits clinical signs and symptoms of infection
8. Known allergy or known sensitivity to Aminoglycosides, such as Gentamicin sulfate or Streptomycin sulfate
9. Clinically significant abnormal laboratory tests at baseline, including CBC, PT/PTT/INR, liver function and creatinine, as determined by the investigator
10. Patients who are non-ambulatory
11. 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
12. Prior radiation at the site
13. Use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment
14. Immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV)
15. 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
16. 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)
17. Workers' compensation patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
20% improvement over baseline Visual Analog Scale for Pain	Visual Analog Scale	3 Months
Incidence of adverse events	Review AE at every visit	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
20% improvement in Foot Function Index-Revised (FFI-R) score from baseline	Foot Function Index	3 months
Blood sample analysis for immuno-compatibility of first 20 patients in each treatment arm	Lab blood draws	3 and 12 months
Long-term FFI-R outcomes	Foot Function Index	6 and 12 months
Long-term Visual Analog Scale (VAS) Pain outcomes	Visual Analog Scale	6 and 12 months
Long-term blood sample analysis for immuno-compatibility of first 20 patients in each treatment arm	Lab blood draws	6 and 12 months

Collaborators and Investigators

• Sponsor: MiMedx Group, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2015
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: April 22, 2015
• First Submitted That Met QC Criteria: April 24, 2015
• First Posted (Estimate): April 27, 2015

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 13, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Chronic plantar fasciitis; Heel pain
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: AIPF004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No