Tendonitis;AchillesPhase 3NCT03414255
Micronized dHACM Injectable for the Treatment of Achille Tendonitis
A Phase 3 study testing Micronized DHACM and Saline Injection in people with Tendonitis;Achilles, run by MiMedx Group, Inc. at 14 sites in United States.
Trial summary
Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to Saline Placebo Injection in the Treatment of Achilles Tendonitis Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Tendonitis;Achilles
- What is being tested?
- Micronized DHACM and Saline Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 14 sitesUnited States
- Study dates
- 9 Jan 2018to 30 Mar 2021
- Phase
- Phase 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects enrolled must meet all the following criteria:
- Confirmed diagnosis of Achilles tendonitis for ≥ 1 month (30 days) and ≤ 18 months by the investigator
- VAS Pain scale of ≥ 45 at randomization
- Achilles Tendonitis with conservative treatment for ≥1 month (30 days) while under the direction of the healthcare provider, including any of the following modalities:
- Rest, Ice, Compression, Elevation (RICE)
- Stretching exercises
Show all 39Show fewer
- Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
- Orthotics
- Diagnostic AP and lateral X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities
- BMI ≤ 40 kg/m2
- Age from 21 to 80 years
- Ability to sign Informed Consent and Release of Medical Information Forms
- Ability to receive and respond to text messages or emails on a daily basis.
- Exclusion Criteria Any potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization.
- Prior surgery to the affected site.
- Subjects requiring bilateral Achilles tendonitis 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 diagnosed comorbidities that can be confused with or can exacerbate the condition- to be assessed by X-ray - including but not limited to:
- Calcaneal stress fracture
- Suspected partial thickness tear of the Achilles tendon, as assessed by the investigator
- Calcaneal tumor
- Tarsal tunnel syndrome (diagnosed)
- Significant bone deformity of the foot that may interfere with the study
- The presence of diagnosed comorbidities that require surgery or are unlikely to improve - to be assessed by Investigator-including but not limited to:
- Nerve entrapment syndrome
- Acute traumatic rupture of the Achilles tendon
- Partial thickness tears of the Achilles Tendon
- Affected site exhibits clinical signs and symptoms of infection
- Known allergy or known sensitivity to Aminoglycosides
- Subjects who are non-ambulatory
- History of more than 14 days of treatment with immune-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 system disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV) or Lyme disease
- History of any conditions (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
Who cannot join
None listed.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
University Orthopedics Center
Altoona, Pennsylvania, 16602
Central Research Associates
Birmingham, Alabama, 35205
Northside Podiatry
Buford, Georgia, 30518
ILD Research Center
Carlsbad, California, 92009
Advanced Foot & Ankle Center
Las Vegas, Nevada, 89119
Foot and Ankle Clinic
Los Angeles, California, 90057
Futuro Clinical Trials
McAllen, Texas, 78501
South Florida Veterans Affairs
Miami, Florida, 33125
Doctors Research Network
Miami, Florida, 33143
Five Cities Foot Clinic
Pismo Beach, California, 93449
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
Foot and Ankle Center of Illinois
Springfield, Illinois, 62704
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
Coastal Podiatry, Inc.
Virginia Beach, Virginia, 23464
About this study
Official title: A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial Of The Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Achilles Tendonitis
Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to Saline Placebo Injection in the Treatment of Achilles Tendonitis
Read the detailed description
Approximately 158 subjects 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. Randomization will be 1:1. The study is expected to be completed in 24 months, inclusive of enrollment and follow-up of all subjects.
- Conditions
- Tendonitis;Achilles
- Being tested
- Micronized DHACM, Saline Injection
- Keywords
- Chronic Achilles Tendonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronized DHACMBiological
Also called dHACM
1 mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM).
Saline InjectionDrug
Also called 0.9% NaCL, Normal Saline, Sodium Chloride Injection, USP
Injection of 1mL 0.9% Sodium Chloride Injection, USP
| Study group | Role | What they receive |
|---|---|---|
| Micronized DHACM | Experimental | 1mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM) Receives: Biological: Micronized DHACM |
| 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.
Change in VAS score
Visual Analog Scale, Left end point is "No Pain". Right end point is "worst pain imaginable"
Measured: 90 days
Incidence of adverse events
The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events during the first 12 months post injection
Measured: 365 days
Secondary outcomes (1)
Foot Function Index Revised (FFI-R) (Short Form)
Subjects circle the number that correlates how bad their foot pain was in certain situation.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start9 Jan 2018
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tendonitis;AchillesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 146 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
- NCT03414255
- Sponsor's protocol ID
- AIAT001
- Status last verified
- May 2020
- First submitted
- 23 Jan 2018
- Last updated
- 19 May 2022
- 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 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial Of The Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Achilles Tendonitis
- ClinicalTrials.gov ID
- NCT03414255
- Acronym / sponsor ID
- AIAT001
- Conditions
- Tendonitis;Achilles
- Keywords
- Chronic Achilles Tendonitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 29 Jan 2018 (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.
Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to Saline Placebo Injection in the Treatment of Achilles Tendonitis
Detailed description
Approximately 158 subjects 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. Randomization will be 1:1. The study is expected to be completed in 24 months, inclusive of enrollment and follow-up of all subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micronized DHACM | Experimental | Biological: Micronized DHACM1mL injection of 40mg 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 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (39 listed)
- Confirmed diagnosis of Achilles tendonitis for ≥ 1 month (30 days) and ≤ 18 months by the investigator
- VAS Pain scale of ≥ 45 at randomization
- Achilles Tendonitis with conservative treatment for ≥1 month (30 days) while under the direction of the healthcare provider, including any of the following modalities:
- Diagnostic AP and lateral 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 (0 listed)
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 |
|---|---|---|
| Micronized DHACMAlso: dHACM1 mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM). | Biological | Micronized DHACM |
| Saline InjectionAlso: 0.9% NaCL, Normal Saline, Sodium Chloride Injection, USPInjection of 1mL 0.9% Sodium Chloride Injection, USP | Drug | Saline Injection |
Primary outcome
Change in VAS score
Time frame: 90 days
Visual Analog Scale, Left end point is "No Pain". Right end point is "worst pain imaginable"
Incidence of adverse events
Time frame: 365 days
The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events during the first 12 months post injection
1 secondary outcome
Foot Function Index Revised (FFI-R) (Short Form)
Time frame: 90 days
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 19 May 2022.
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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
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Micronized DHACM and Saline Injection in people with Tendonitis;Achilles, run by MiMedx Group, Inc. at 14 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 39 inclusion and 0 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 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 phase mean?
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?
Change in VAS score (time frame: 90 days). 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 19 May 2022.