Plantar FasciitisNCT04088383
Amnios™ RT Outcomes Study
A study testing Amnios™ RT and Saline in people with Plantar Fasciitis, run by Globus Medical Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Amnios™ RT and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2019to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Plantar Fasciitis
- Being tested
- Amnios™ RT, Saline
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amnios™ RTOther
Acellular human allograft
SalineOther
Sterile saline
| Study group | Role | What they receive |
|---|---|---|
| Amnios™ RT | Other | Not described Receives: Other: Amnios™ RT |
| Saline | Placebo comparator | Not described Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Months
Serious Adverse Events
The occurrence of serious adverse events that are related to the product.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start10 Sep 2019
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Globus Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088383
- Sponsor's protocol ID
- Rev0
- Status last verified
- Feb 2023
- First submitted
- 11 Sep 2019
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double Blind Investigation of Amnios™ RT for the Treatment of Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT04088383
- Acronym / sponsor ID
- Rev0
- Conditions
- Plantar Fasciitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Globus Medical IncIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amnios™ RT | Other | Other: Amnios™ RT |
| Saline | Placebo comparator | Other: Saline |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Diagnostic radiograph within 6 months of enrollment showing view of calcaneus, without evidence of calcaneal fracture or structural abnormalities
- BMI ≤ 40 kg/m2
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amnios™ RTAcellular human allograft | Other | Amnios™ RT |
| SalineSterile saline | Other | Saline |
Primary outcome
Visual Analog Scale (VAS) Foot Pain Score
Time frame: 3 Months
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.
Serious Adverse Events
Time frame: 12 Months
The occurrence of serious adverse events that are related to the product.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amnios™ RT and Saline in people with Plantar Fasciitis, run by Globus Medical Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) Foot Pain Score (time frame: 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.