Clinical trial NCT03414268: Micronized dHACM Injectable for the Treatment of Plantar Fasciitis
Official title: A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fasciitis, Plantar
Keywords: Chronic plantar fasciitis
Heel pain
Lead sponsor: MiMedx Group, Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-29
Enrollment: 208
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, 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.

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 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

Primary outcomes:
measure: Change in VAS score
timeFrame: 90 Days
measure: Incidence of adverse events
timeFrame: 180 Days
Secondary outcomes:
measure: Foot Function Index - Revised (FFI-R) (Short Form)
timeFrame: 90 Days
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
city: Carlsbad
country: United States
facility: ILD Research Center
state: California
city: Carmichael
country: United States
facility: Center for Clinical Research
state: California
city: Fresno
country: United States
facility: Limb Preservation Platform, Inc.
state: California
city: La Mesa
country: United States
facility: Horizon Clinical Research
state: California
city: Los Angeles
country: United States
facility: Foot and Ankle Clinic
state: California
city: Pismo Beach
country: United States
facility: Five Cities Foot Clinic
state: California
city: Bay Pines
country: United States
facility: Bay Pines VA Healthcare System
state: Florida
city: Sarasota
country: United States
facility: Gulfcoast Research Institute, LLC
state: Florida
city: South Miami
country: United States
facility: Doctors Research Network
state: Florida
city: Baltimore
country: United States
facility: Union Podiatry
state: Maryland
city: Las Vegas
country: United States
facility: Advanced Foot & Ankle Center
state: Nevada
city: Altoona
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: State College
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: McAllen
country: United States
facility: Futuro Clinical Trials, LLC
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: Virginia Beach
country: United States
facility: Coastal Podiatry
state: Virginia
Study officials:
affiliation: MedStar Union Memorial Hospital, Baltimore, MD
name: Stuart D Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: