Micronized dHACM Injectable for the Treatment of Plantar Fasciitis

Phase 2

Completed

• Conditions: Fasciitis, Plantar
• Interventions: Other: AmnioFix® Injectable; Drug: Saline Injection

• Registration Number: NCT02427191
• Lead Sponsor: MiMedx Group, Inc.

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

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 Timeline

• Study Start: 2015-03-31
• Study First Submitted: 2015-04-22
• Study First Submitted QC: 2015-04-24
• Study First Posted: 2015-04-27
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-13
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AmnioFix® Injectable	AmnioFix® Injectable	1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)
Saline Injection	Saline Injection	Injection of 1mL 0.9% Sodium Chloride Injection, USP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (11)

Southern Arizona VA Health Care System; 🇺🇸 Tucson, Arizona, United States

James A. Lovell Federal Health Care Center; 🇺🇸 North Chicago, Illinois, United States

Scott & White Healthcare; 🇺🇸 Temple, Texas, United States

Limb Preservation Platform, Inc.; 🇺🇸 Fresno, California, United States

Center for Clinical Research, Inc.; 🇺🇸 San Francisco, California, United States

Edward Hines Jr. Veterans Administration Hospital; 🇺🇸 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

Orlando VA Healthcare System; 🇺🇸 Orlando, Florida, United States

Coastal Podiatry Group; 🇺🇸 Virginia Beach, Virginia, United States