Micronized dHACM Injectable for the Treatment of Plantar Fasciitis

Phase 3

Completed

• Conditions: Fasciitis, Plantar
• Interventions: Other: Micronized dHACM; Drug: Saline Injection

• Registration Number: NCT03414268
• Lead Sponsor: 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

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.

Study Timeline

• Study Start: 2018-01-08
• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-01-26
• Study First Posted: 2018-01-29
• Status Verified: 2020-10
• Primary Completion: 2021-03-17
• Study Completion: 2021-03-17
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Micronized dHACM	Micronized dHACM	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
Incidence of adverse events	180 Days	The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events during the first 12 months post injection
Change in VAS score	90 Days	Visual Analog Scale for Pain:

Secondary Outcome Measures

Name	Time	Method
Foot Function Index - Revised (FFI-R) (Short Form)	90 Days	Foot Function Index - Revised: Patient Reported Questionnaire

Trial Locations

Locations (16)

ILD Research Center; 🇺🇸 Carlsbad, California, United States

Horizon Clinical Research; 🇺🇸 La Mesa, California, United States

Five Cities Foot Clinic; 🇺🇸 Pismo Beach, California, United States

Futuro Clinical Trials, LLC; 🇺🇸 McAllen, Texas, United States

Center for Clinical Research; 🇺🇸 Carmichael, California, United States

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

Foot and Ankle Clinic; 🇺🇸 Los Angeles, California, United States

Gulfcoast Research Institute, LLC; 🇺🇸 Sarasota, Florida, United States

Union Podiatry; 🇺🇸 Baltimore, Maryland, United States

Advanced Foot & Ankle Center; 🇺🇸 Las Vegas, Nevada, United States

University Orthopedics Center; 🇺🇸 State College, Pennsylvania, United States

Endeavor Clinical Trials; 🇺🇸 San Antonio, Texas, United States

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

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

Bay Pines VA Healthcare System; 🇺🇸 Bay Pines, Florida, United States

Doctors Research Network; 🇺🇸 South Miami, Florida, United States