Fasciitis, PlantarPhase 2/3dHACMNCT02427191
Micronized dHACM Injectable for the Treatment of Plantar Fasciitis
A Phase 2/3 study testing AmnioFix® Injectable and Saline Injection in people with Fasciitis, Plantar, run by MiMedx Group, Inc. at 11 sites in United States.
Trial summary
Prospective, single-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis Read more about this study
- Who is it for?
- Ages 21 to 79 years
- Conditions the study is for
- Fasciitis, Plantar
- What is being tested?
- AmnioFix® Injectable and Saline Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 11 sitesUnited States
- Study dates
- 31 Mar 2015to Aug 2018
- Phase
- Phase 2/3
- 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 21 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of plantar fasciitis for ≥ 1 month (30 days) and ≤ 18 months by the investigator
- VAS Pain scale of ≥ 45 mm 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 X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities
- BMI ≤ 40 kg/m2
- Age ≥ 21 years and < 80
- Ability to sign Informed Consent and Release of Medical Information Forms
Who cannot join
- Prior surgery or trauma to the affected site
- Subjects requiring bilateral plantar fasciitis treatment at time of enrollment
- Prior use of any lower limb injection therapy, including corticosteroids or PRP in either limb within the last 3 months
- Has diabetes either Type I or Type II
- Systemic disorders associated with enthesopathy (disorder of entheses, i.e. bone attachments) such as Gout, Reiter's syndrome, rheumatoid arthritis, etc.
- The presence of comorbidities that can be confused with or can exacerbate the condition- to be assessed by X-ray - including but not limited to:
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- Calcaneal stress fracture
- Nerve entrapment syndrome (Baxter Nerve Syndrome)
- Fat pad atrophy
- Acute traumatic rupture of the plantar fascia
- Calcaneal tumor
- Tarsal tunnel syndrome
- Significant bone deformity of the foot that may interfere with the study
- Affected site exhibits clinical signs and symptoms of infection
- Known allergy or known sensitivity to Aminoglycosides, such as Gentamicin sulfate or Streptomycin sulfate
- Clinically significant abnormal laboratory tests at baseline, including CBC, PT/PTT/INR, liver function and creatinine, as determined by the investigator
- Patients who are non-ambulatory
- History of more than 14 days 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
- Use of any investigational drug(s) or 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)
- Workers' compensation patients
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Timonium Foot and Ankle Center
Baltimore, Maryland, 21093
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218
Edward Hines Jr. Veterans Administration Hospital
Chicago, Illinois, 60141
WJB Dorn VA Medical Center
Columbia, South Carolina, 29209
Limb Preservation Platform, Inc.
Fresno, California, 93721
James A. Lovell Federal Health Care Center
North Chicago, Illinois, 60064
Orlando VA Healthcare System
Orlando, Florida, 32803
Center for Clinical Research, Inc.
San Francisco, California, 94115
Scott & White Healthcare
Temple, Texas, 76508
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
Coastal Podiatry Group
Virginia Beach, Virginia, 23464
About this study
Official title: A Prospective, Single-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to the Saline Placebo Injection in the Treatment of Plantar Fasciitis
Prospective, single-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis
Read the detailed description
Approximately 146 patients will be enrolled in this study. Each patient will receive 1 injection and be evaluated for efficacy and safety during a 12-month observation period. The study is expected to be completed within 36 months, inclusive of enrollment and follow-up of all subjects.
- Conditions
- Fasciitis, Plantar
- Being tested
- AmnioFix® Injectable, Saline Injection
- Keywords
- Chronic plantar fasciitis, Heel pain
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmnioFix® InjectableOther
Also called dHACM
1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)
Saline InjectionDrug
Also called 0.9% NaCl, Normal Saline
Injection of 1mL 0.9% Sodium Chloride Injection, USP
| Study group | Role | What they receive |
|---|---|---|
| AmnioFix® Injectable | Experimental | 1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM) Receives: Other: AmnioFix® Injectable |
| Saline Injection | Placebo comparator | Injection of 1mL 0.9% Sodium Chloride Injection, USP Receives: Drug: Saline Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
20% improvement over baseline Visual Analog Scale for Pain
Visual Analog Scale
Measured: 3 Months
Incidence of adverse events
Review AE at every visit
Measured: 12 months
Secondary outcomes (5)
20% improvement in Foot Function Index-Revised (FFI-R) score from baseline
Foot Function Index
Measured: 3 months
Blood sample analysis for immuno-compatibility of first 20 patients in each treatment arm
Lab blood draws
Measured: 3 and 12 months
Long-term FFI-R outcomes
Foot Function Index
Measured: 6 and 12 months
Long-term Visual Analog Scale (VAS) Pain outcomes
Visual Analog Scale
Measured: 6 and 12 months
Long-term blood sample analysis for immuno-compatibility of first 20 patients in each treatment arm
Lab blood draws
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study start31 Mar 2015
- Primary completionAug 2018
- Study completionAug 2018
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart D Miller, MD, Principal investigator, MedStar Union Memorial Hospital, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427191
- Sponsor's protocol ID
- AIPF004
- Acronym
- dHACM
- Status last verified
- Nov 2020
- First submitted
- 22 Apr 2015
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to the Saline Placebo Injection in the Treatment of Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT02427191
- Acronym / sponsor ID
- dHACM / AIPF004
- Conditions
- Fasciitis, Plantar
- Keywords
- Chronic plantar fasciitis, Heel pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 27 Apr 2015 (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.
Prospective, single-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis
Detailed description
Approximately 146 patients will be enrolled in this study. Each patient will receive 1 injection and be evaluated for efficacy and safety during a 12-month observation period. The study is expected to be completed within 36 months, inclusive of enrollment and follow-up of all subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AmnioFix® Injectable | Experimental | Other: AmnioFix® Injectable1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM) |
| Saline Injection | Placebo comparator | Drug: Saline InjectionInjection of 1mL 0.9% Sodium Chloride Injection, USP |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Confirmed diagnosis of plantar fasciitis for ≥ 1 month (30 days) and ≤ 18 months by the investigator
- VAS Pain scale of ≥ 45 mm at randomization
- Plantar fasciitis with conservative treatment for ≥ 1 month (30 days), including any of the following modalities:
- Diagnostic X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities
- BMI ≤ 40 kg/m2
Key exclusion criteria (24 listed)
- Prior surgery or trauma to the affected site
- Subjects requiring bilateral plantar fasciitis treatment at time of enrollment
- Prior use of any lower limb injection therapy, including corticosteroids or PRP in either limb within the last 3 months
- Has diabetes either Type I or Type II
- Systemic disorders associated with enthesopathy (disorder of entheses, i.e. bone attachments) such as Gout, Reiter's syndrome, 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 |
|---|---|---|
| AmnioFix® InjectableAlso: dHACM1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM) | Other | AmnioFix® Injectable |
| Saline InjectionAlso: 0.9% NaCl, Normal SalineInjection of 1mL 0.9% Sodium Chloride Injection, USP | Drug | Saline Injection |
Primary outcome
20% improvement over baseline Visual Analog Scale for Pain
Time frame: 3 Months
Visual Analog Scale
Incidence of adverse events
Time frame: 12 months
Review AE at every visit
5 secondary outcomes
20% improvement in Foot Function Index-Revised (FFI-R) score from baseline
Time frame: 3 months
Blood sample analysis for immuno-compatibility of first 20 patients in each treatment arm
Time frame: 3 and 12 months
Long-term FFI-R outcomes
Time frame: 6 and 12 months
Long-term Visual Analog Scale (VAS) Pain outcomes
Time frame: 6 and 12 months
Long-term blood sample analysis for immuno-compatibility of first 20 patients in each treatment arm
Time frame: 6 and 12 months
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 17 Nov 2020.
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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.
Stuart D Miller, MD principal investigator
MedStar Union Memorial Hospital, Baltimore, MD
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing AmnioFix® Injectable and Saline Injection in people with Fasciitis, Plantar, run by MiMedx Group, Inc. at 11 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 11 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 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
20% improvement over baseline Visual Analog Scale for Pain (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 17 Nov 2020.