Amnios™ RT Outcomes Study

NCT ID: NCT04088383

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-10
• Study Completion Date: 2022-11-30

Brief Summary

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.

Conditions

Plantar Fasciitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Amnios™ RT

Group Type: OTHER

Amnios™ RT

Intervention Type: OTHER

Acellular human allograft

Saline

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: OTHER

Sterile saline

Interventions

Amnios™ RT

Acellular human allograft

Intervention Type: OTHER

Saline

Sterile saline

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Globus Medical Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bio-X-Cell Research

San Antonio, Texas, United States

Countries

United States

Other Identifiers

Rev0

Identifier Type: -

Identifier Source: org_study_id