Micronized dHACM Injectable for the Treatment of Plantar Fasciitis

Fasciitis, Plantar Clinical Trial

— dHACM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427191
• Other study ID #: AIPF004
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 31, 2015
• Est. completion date: August 2018

Study information

• Verified date: November 2020
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar

Intervention

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

Drug:
• Saline Injection
Injection of 1mL 0.9% Sodium Chloride Injection, USP

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	20% improvement over baseline Visual Analog Scale for Pain	Visual Analog Scale	3 Months
Primary	Incidence of adverse events	Review AE at every visit	12 months
Secondary	20% improvement in Foot Function Index-Revised (FFI-R) score from baseline	Foot Function Index	3 months
Secondary	Blood sample analysis for immuno-compatibility of first 20 patients in each treatment arm	Lab blood draws	3 and 12 months
Secondary	Long-term FFI-R outcomes	Foot Function Index	6 and 12 months
Secondary	Long-term Visual Analog Scale (VAS) Pain outcomes	Visual Analog Scale	6 and 12 months
Secondary	Long-term blood sample analysis for immuno-compatibility of first 20 patients in each treatment arm	Lab blood draws	6 and 12 months