Clinical trial NCT02427191: Micronized dHACM Injectable for the Treatment of Plantar Fasciitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Fasciitis, Plantar
Keywords: Chronic plantar fasciitis
Heel pain
Lead sponsor: MiMedx Group, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-27
Enrollment: 147
Sex: ALL
Minimum age (years): 21
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 20% improvement over baseline Visual Analog Scale for Pain
timeFrame: 3 Months
measure: Incidence of adverse events
timeFrame: 12 months
Secondary outcomes:
measure: 20% improvement in Foot Function Index-Revised (FFI-R) score from baseline
timeFrame: 3 months
measure: Blood sample analysis for immuno-compatibility of first 20 patients in each treatment arm
timeFrame: 3 and 12 months
measure: Long-term FFI-R outcomes
timeFrame: 6 and 12 months
measure: Long-term Visual Analog Scale (VAS) Pain outcomes
timeFrame: 6 and 12 months
measure: Long-term blood sample analysis for immuno-compatibility of first 20 patients in each treatment arm
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
city: Fresno
country: United States
facility: Limb Preservation Platform, Inc.
state: California
city: San Francisco
country: United States
facility: Center for Clinical Research, Inc.
state: California
city: Orlando
country: United States
facility: Orlando VA Healthcare System
state: Florida
city: Chicago
country: United States
facility: Edward Hines Jr. Veterans Administration Hospital
state: Illinois
city: North Chicago
country: United States
facility: James A. Lovell Federal Health Care Center
state: Illinois
city: Baltimore
country: United States
facility: Timonium Foot and Ankle Center
state: Maryland
city: Baltimore
country: United States
facility: MedStar Union Memorial Hospital
state: Maryland
city: Columbia
country: United States
facility: WJB Dorn VA Medical Center
state: South Carolina
city: Temple
country: United States
facility: Scott & White Healthcare
state: Texas
city: Virginia Beach
country: United States
facility: Coastal Podiatry Group
state: Virginia
Study officials:
affiliation: MedStar Union Memorial Hospital, Baltimore, MD
name: Stuart D Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: