Micronized dHACM Injectable for the Treatment of Plantar Fasciitis

NCT ID: NCT02427191

Last Updated: 2020-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2018-08-31

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.

Conditions

Fasciitis, Plantar

Keywords

Chronic plantar fasciitis; Heel pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

AmnioFix® Injectable

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

Group Type: EXPERIMENTAL

AmnioFix® Injectable

Intervention Type: OTHER

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

Saline Injection

Injection of 1mL 0.9% Sodium Chloride Injection, USP

Group Type: PLACEBO_COMPARATOR

Saline Injection

Intervention Type: DRUG

Injection of 1mL 0.9% Sodium Chloride Injection, USP

Interventions

AmnioFix® Injectable

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

Intervention Type: OTHER

Saline Injection

Injection of 1mL 0.9% Sodium Chloride Injection, USP

Intervention Type: DRUG

Other Intervention Names

dHACM; 0.9% NaCl; Normal Saline

Eligibility 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

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MiMedx Group, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stuart D Miller, MD

Role: PRINCIPAL_INVESTIGATOR

MedStar Union Memorial Hospital, Baltimore, MD

Locations

Southern Arizona VA Health Care System

Tucson, Arizona, United States

Limb Preservation Platform, Inc.

Fresno, California, United States

Center for Clinical Research, Inc.

San Francisco, California, United States

Orlando VA Healthcare System

Orlando, Florida, United States

Edward Hines Jr. Veterans Administration Hospital

Chicago, Illinois, United States

James A. Lovell Federal Health Care Center

North 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

Scott & White Healthcare

Temple, Texas, United States

Coastal Podiatry Group

Virginia Beach, Virginia, United States

Countries

United States

Other Identifiers

AIPF004

Identifier Type: -

Identifier Source: org_study_id