Amnios™ RT Outcomes Study

Globus Medical

Status

Completed

Conditions

Plantar Fasciitis

Treatments

Other: Saline

Other: Amnios™ RT

Study type

Interventional

Funder types

Industry

Identifiers

NCT04088383

Rev0

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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