Fasciitis, PlantarNCT02982226
ReNu™ vs. Corticosteroids for the Treatment of Plantar Fasciitis
A study testing ReNu Injection and Corticosteroid Injection in people with Fasciitis, Plantar, run by NuTech Medical, Inc at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fasciitis, Plantar
- What is being tested?
- ReNu Injection and Corticosteroid Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2016to Apr 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 to 75 inclusive
- BMI less than 40
- Actively practicing a contraception method, abstinent, surgically sterile, or post-menopausal (defined as no menses for a minimum of 12 months)
- Reporting heel pain of >6 on a verbally administered 1-10 pain scale where 1 is no pain and 10 is extreme pain
- Diagnosed with plantar fasciitis in either foot
- Completed a minimum of two months of conservative, non-injection treatment/therapies (i.e., activity modification, icing, NSAIDs, orthotics, physical therapy, etc.)
Who cannot join
- Prior surgery on the affected foot
- Prior injection treatment for plantar fasciitis within the past 6 months with steroids or tissue engineered materials just in the site seeking treatment
- Clinical signs and symptoms of infection of foot in question
- Evidence of significant neurological disease of either foot
- Non-ambulatory
- Presence of comorbidities that can be confused with or can exacerbate the condition including, but not limited to the following:
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- 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
- 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.
- Has taken NSAID medication within the past 14 days, or other pain medication in the past day
- 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.
- Taking any investigational drug(s) or therapeutic device(s) within 30 days preceding screening
- History of radiation therapy of the affected foot
- Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
- Involved in a Worker's Compensation Claim of any kind
- Unable to understand the objectives of the trial
- Presence of any condition(s) which, in the opinion of the investigator, would compromise the subject's ability to complete this study
- Having a known history of poor adherence with medical treatment.
- Express an unwillingness to receive human allograft tissue
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Geisinger
Danville, Pennsylvania
Advanced Orthopedics
Denver, Colorado, 80230
Orlando Food and Ankle Clinic
Orlando, Florida, 32806
Lower Extremity Institute of Research & Therapy (LEIRT)
Poland, Ohio, 44514
The Vancouvover Clinic
Vancouver, Washington, 98686
The Iowa Clinic Foot and Ankle Surgery
West Des Moines, Iowa, 50266
About this study
Official title: A Comparative Study of Injectable Human Amniotic Allograft (ReNu™) Versus Corticosteroids for Plantar Fasciitis: A Prospective, Randomized, Blinded Study
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.
Read the 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.
- Conditions
- Fasciitis, Plantar
- Being tested
- ReNu Injection, Corticosteroid Injection
- Keywords
- Plantar Fasciitis, Jogger's Heel, ReNu
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReNu InjectionOther
ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.
Corticosteroid InjectionOther
Corticosteroids are considered a standard of care for treatment of Plantar Fasciitis
| Study group | Role | What they receive |
|---|---|---|
| ReNu Injection | Experimental | Plantar Fascia injection with ReNu. ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid. Receives: Other: ReNu Injection |
| Corticosteroid Injection | Active comparator | Plantar Fascia injection with Corticosteroids. Receives: Other: Corticosteroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AOFAS score from baseline
Measured: 6 months
Secondary outcomes (3)
Change in VAS pain score from baseline
Measured: 6 months
Change in SANE function score from baseline
Measured: 6 months
Return to Normal Function between treatment groups
Assessed using questionnaire by the Principal Investigator (PI)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fasciitis, PlantarStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NuTech Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MileStone Research Organization, Organogenesis
- Responsible party
- Sponsor
- Investigators
- Alan Ng, DPM, FACFAS, Principal investigator, Advanced Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982226
- Sponsor's protocol ID
- RD-2015-08-05
- Status last verified
- Apr 2020
- First submitted
- 29 Nov 2016
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Injectable Human Amniotic Allograft (ReNu™) Versus Corticosteroids for Plantar Fasciitis: A Prospective, Randomized, Blinded Study
- ClinicalTrials.gov ID
- NCT02982226
- Acronym / sponsor ID
- RD-2015-08-05
- Conditions
- Fasciitis, Plantar
- Keywords
- Plantar Fasciitis, Jogger's Heel, ReNu
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- NuTech Medical, IncIndustry (pharma, biotech, devices)
- Collaborators
- MileStone Research Organization, Organogenesis
- Study start
- Sep 2016 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 5 Dec 2016 (estimated)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ReNu Injection | Experimental | Other: ReNu InjectionPlantar Fascia injection with ReNu. ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid. |
| Corticosteroid Injection | Active comparator | Other: Corticosteroid InjectionPlantar Fascia injection with Corticosteroids. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages 18 to 75 inclusive
- BMI less than 40
- Actively practicing a contraception method, abstinent, surgically sterile, or post-menopausal (defined as no menses for a minimum of 12 months)
- Reporting heel pain of >6 on a verbally administered 1-10 pain scale where 1 is no pain and 10 is extreme pain
- Diagnosed with plantar fasciitis in either foot
Key exclusion criteria (25 listed)
- Prior surgery on the affected foot
- Prior injection treatment for plantar fasciitis within the past 6 months with steroids or tissue engineered materials just in the site seeking treatment
- Clinical signs and symptoms of infection of foot in question
- Evidence of significant neurological disease of either foot
- Non-ambulatory
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 |
|---|---|---|
| ReNu InjectionReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid. | Other | ReNu Injection |
| Corticosteroid InjectionCorticosteroids are considered a standard of care for treatment of Plantar Fasciitis | Other | Corticosteroid Injection |
Primary outcome
Change in AOFAS score from baseline
Time frame: 6 months
3 secondary outcomes
Change in VAS pain score from baseline
Time frame: 6 months
Change in SANE function score from baseline
Time frame: 6 months
Return to Normal Function between treatment groups
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Alan Ng, DPM, FACFAS principal investigator
Advanced Orthopedics
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReNu Injection and Corticosteroid Injection in people with Fasciitis, Plantar, run by NuTech Medical, Inc at 6 sites 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 6 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. 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?
Results are not available in the source record.
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?
Change in AOFAS score from baseline (time frame: 6 months). 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 21 Apr 2020.