Clinical trial NCT02982226: ReNu™ vs. Corticosteroids for the Treatment of Plantar Fasciitis
Official title: A Comparative Study of Injectable Human Amniotic Allograft (ReNu™) Versus Corticosteroids for Plantar Fasciitis: A Prospective, Randomized, Blinded Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fasciitis, Plantar
Keywords: Plantar Fasciitis
Jogger's Heel
ReNu
Lead sponsor: NuTech Medical, Inc
Sponsor class: INDUSTRY
Collaborators: name: MileStone Research Organization
name: Organogenesis
First posted: 2016-12-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this clinical trial is to evaluate both the safety and efficacy of the ReNu™ injection on pain and inflammation in subjects diagnosed with plantar fasciitis as compared to a Corticosteroid Injection which is considered standard of care.

Detailed description: This is a two (2) arm evaluation in 150 subjects with plantar fasciitis. Patients will be treated with ReNu™(study treatment) or Corticosteroids (control).

At each follow-up visit, concomitant medications and adverse events shall be collected from each subject, and each subject shall complete following questionnaires:

* AOFAS Ankle-Hindfoot Score (AOFAS-AHS)
* Visual Analog Score (VAS)
* Single Answer Numeric Evaluation (SANE)
* Subject Satisfaction Score (at the 6 Month Follow Ups ONLY)

The subjects will be assessed at Baseline (pre-injection) using these scales and again at all subsequent study follow-up visits.

Eligibility criteria: Inclusion Criteria:

1. Ages 18 to 75 inclusive
2. BMI less than 40
3. Actively practicing a contraception method, abstinent, surgically sterile, or post-menopausal (defined as no menses for a minimum of 12 months)
4. Reporting heel pain of \>6 on a verbally administered 1-10 pain scale where 1 is no pain and 10 is extreme pain
5. Diagnosed with plantar fasciitis in either foot
6. Completed a minimum of two months of conservative, non-injection treatment/therapies (i.e., activity modification, icing, NSAIDs, orthotics, physical therapy, etc.)

Exclusion Criteria

1. Prior surgery on the affected foot
2. Prior injection treatment for plantar fasciitis within the past 6 months with steroids or tissue engineered materials just in the site seeking treatment
3. Clinical signs and symptoms of infection of foot in question
4. Evidence of significant neurological disease of either foot
5. Non-ambulatory
6. Presence of comorbidities that can be confused with or can exacerbate the condition including, but not limited to the following:

   * Calcaneal stress fracture
   * Nerve entrapment syndrome, such as Baxter's Nerve Entrapment or Tarsal Tunnel Syndrome
   * Plantar Fascial rupture
   * Systemic disorders associated with enthesiopathy, i.e., Gout, Reiter's syndrome, rheumatoid arthritis, etc.
   * Achilles tendonitis
   * Fat Pad Atrophy
   * Fibromyalgia
   * Diabetic Neuropathy
7. Pregnant, pregnant within the past six (6) months, breast feeding and/or desire to become pregnant during the course of the study, as verified by urine pregnancy test within one week prior to injection.
8. Has taken NSAID medication within the past 14 days, or other pain medication in the past day
9. History of more than two (2) weeks treatment with immuno-suppressants, including systemic corticosteroids or cytotoxic chemotherapy within one month prior to initial screening, or has receive such medications during the screening period, or are anticipated to require such medications during the course of the study.
10. Taking any investigational drug(s) or therapeutic device(s) within 30 days preceding screening
11. History of radiation therapy of the affected foot
12. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
13. Involved in a Worker's Compensation Claim of any kind
14. Unable to understand the objectives of the trial
15. Presence of any condition(s) which, in the opinion of the investigator, would compromise the subject's ability to complete this study
16. Having a known history of poor adherence with medical treatment.
17. Express an unwillingness to receive human allograft tissue

Primary outcomes:
measure: Change in AOFAS score from baseline
timeFrame: 6 months
Secondary outcomes:
measure: Change in VAS pain score from baseline
timeFrame: 6 months
measure: Change in SANE function score from baseline
timeFrame: 6 months
measure: Return to Normal Function between treatment groups
timeFrame: 6 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Advanced Orthopedics
state: Colorado
city: Orlando
country: United States
facility: Orlando Food and Ankle Clinic
state: Florida
city: West Des Moines
country: United States
facility: The Iowa Clinic Foot and Ankle Surgery
state: Iowa
city: Poland
country: United States
facility: Lower Extremity Institute of Research & Therapy (LEIRT)
state: Ohio
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
city: Vancouver
country: United States
facility: The Vancouvover Clinic
state: Washington
Study officials:
affiliation: Advanced Orthopedics
name: Alan Ng, DPM, FACFAS
role: PRINCIPAL_INVESTIGATOR
References: