Amnios™ RT Outcomes Study

A Prospective, Randomized, Double Blind Investigation of Amnios™ RT for the Treatment of Plantar Fasciitis

The purpose of this study is to evaluate clinical outcomes of patients with plantar fasciitis following treatment with Amnios™ RT. Patients will be randomized to either Amnios™ RT or a placebo control.

Study Overview

• Status: Completed
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Other: Amnios™ RT; Other: Saline

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Bio-X-Cell Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Confirmed diagnosis of unilateral plantar fasciitis for ≥ 1 month (30 days) and ≤ 18 months by the Investigator
• VAS Foot Pain score of at least 45mm (out of 100mm scale) at randomization

• Plantar fasciitis with conservative treatment for ≥ 1 month (30 days), including any of the following modalities:

  • RICE
  • Stretching exercises
  • NSAIDs
  • Orthotics
• Diagnostic radiograph within 6 months of enrollment showing view of calcaneus, without evidence of calcaneal fracture or structural abnormalities
• BMI ≤ 40 kg/m2
• Age ≥ 18 years and < 80 years
• Willing and able to comply with the follow-up requirements of the protocol
• Signed an Informed Consent Form specific to this research and agreed to release of medical information

Exclusion Criteria:

• Prior surgery or trauma resulting in severe, permanent damage to the affected foot
• Require bilateral plantar fasciitis treatment at time of enrollment (with exception of compensatory symptoms on the non-affected foot)
• Prior use of any lower limb injection therapy, including corticosteroids or PRP in either foot within the last 3 months
• Has Type I or Type II diabetes mellitus
• Systemic disorders associated with enthesopathy (disorder of entheses, i.e. bone attachments) such as Gout, reactive arthritis, rheumatoid arthritis, etc.

• The presence of diagnosed comorbidities that can be confused with or can exacerbate the condition (as assessed by radiograph) including:

  • Calcaneal stress fracture
  • Nerve entrapment syndrome (diagnosed as Baxter Nerve Syndrome)
  • Fat pad atrophy (relative to expectations for patient's age)
  • 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
  • Other malignant tumors in the foot or conditions that may affect study outcomes
• Affected site exhibits clinical signs and symptoms of infection of the foot in question
• Known allergy or known sensitivity to aminoglycosides
• Non-ambulatory
• History of more than 14 days of 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
• Prior radiation at the site, with exception of diagnostic radiographs
• Use of any investigational drug(s) or investigational therapeutic device(s) within 3 months preceding enrollment
• Immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV)
• 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
• 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)
• Prisoner

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline	Other: Saline; Sterile saline
Other: Amnios™ RT	Other: Amnios™ RT; Acellular human allograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) Foot Pain Score	The visual analog scale (VAS) is a patient questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with "no pain" on the left border and "most intense pain imaginable" on the right border. The subject is instructed to place a vertical line on the scale that indicates the pain severity experienced; 0mm is equal to no pain and 100mm is most intense pain imaginable. Study staff records the distance of the patient's mark on the scale in millimeters.	3 Months
Serious Adverse Events	The occurrence of serious adverse events that are related to the product.	12 Months

Collaborators and Investigators

• Sponsor: Globus Medical Inc

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2019
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 11, 2019
• First Posted (Actual): September 12, 2019

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: Rev0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No