Plantar FasciitisdHACMNCT01996111
Dehydrated Human Amnion/Chorion Membrane Micrografts(dHACM) Injectable in the Treatment of Recalcitrant Plantar Fasciitis
A study testing Injection of 1.0 cc of 0.9% Saline, Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension and Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension in people with Plantar Fasciitis, run by MiMedx Group, Inc. at 1 site in United States.
Trial summary
This is a prospective, controlled, randomized, blinded and comparative, single-center clinical trial comparing the improvement of patients with recalcitrant plantar fasciitis symptoms that have received standard of care versus treatment with differing amounts of injectable dehydrated human amnion/chorion membrane… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Injection of 1.0 cc of 0.9% Saline, Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension and Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Apr 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old.
- Both male and female patients will be selected.
- Plantar fasciitis has been treated with conservative usual care for at least 8 weeks, including at least three of the following modalities
- Rest, Ice, Compression, Elevation (RICE)
- Corticosteroid injection
- Stretching exercises
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- Non-steroidal Anti-Inflammatory Drugs (NSAIDs)
- Orthotics
- Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
- Patient understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
- Patient has read and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.
Who cannot join
- Prior surgery at the site.
- Site that exhibits clinical signs and symptoms of infection.
- History of chronic plantar fasciitis of more than twelve months.
- Evidence of significant neurological disease of the feet.
- Non-ambulatory patients.
- The presence of comorbidities that can be confused with or can exacerbate the condition including:
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- Calcaneal stress fracture
- Nerve entrapment syndrome (Baxter's Nerve Entrapment or Tarsal Tunnel Syndrome)
- Plantar fascial rupture
- Systemic disorders associated with enthesiopathy (such as Gout, Reiter's syndrome, rheumatoid arthritis, etc.)
- Achilles tendonitis
- Fat pad atrophy
- Fibromyalgia
- Diabetics with neuropathy
- Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
- Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
- History of radiation therapy at the site.
- Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
- Study foot has been previously treated with tissue engineered materials within the last 30 days.
- Patients who are unable to understand the aims and objectives of the trial.
- Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
- Pregnant or breast feeding. No pregnancy within the past 6 months.
- Allergy to Gentamicin and/or Streptomycin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Professional Education and Research Institute
Roanoke, Virginia, 24016
About this study
Official title: A Prospective, Randomized, Controlled, Blinded, Comparative Study of Dehydrated Human Amnion/Chorion Membrane Micrografts(dHACM) Injectable in the Treatment of Recalcitrant Plantar Fasciitis
This is a prospective, controlled, randomized, blinded and comparative, single-center clinical trial comparing the improvement of patients with recalcitrant plantar fasciitis symptoms that have received standard of care versus treatment with differing amounts of injectable dehydrated human amnion/chorion membrane micrografts(dHACM).
- Conditions
- Plantar Fasciitis
- Being tested
- Injection of 1.0 cc of 0.9% Saline, Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension, Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension, Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension
- Keywords
- plantar fasciitis
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of 1.0 cc of 0.9% SalineProcedure or surgery
Injection of 1.0 cc of 0.9% Saline into affected area
Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspensionProcedure or surgery
Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension into affected area
Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspensionProcedure or surgery
Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension into affected area
Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspensionProcedure or surgery
Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension into affected area
| Study group | Role | What they receive |
|---|---|---|
| • Group 2: | Experimental | Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension Receives: Procedure: Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension |
| • Group 3: | Experimental | Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension Receives: Procedure: Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension |
| • Group 4: | Experimental | Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension Receives: Procedure: Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension |
| • Group 1 | Placebo comparator | • Injection of 1.0 cc of 0.9% Saline Receives: Procedure: Injection of 1.0 cc of 0.9% Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of inflammation as measured by AOFAS Hindfoot scores
The primary objective of this study is to compare the efficacy of the different treatment amounts in reduction of inflammation as measured by AOFAS Hindfoot scores.
Measured: 8 Weeks
Secondary outcomes (2)
Return to normal activities more quickly than with standard of care
The secondary objective is to demonstrate that patients treated with micronized dHACM injectable will return to normal activities more quickly than with standard of care.
Measured: 8 Weeks
Pain as measured by 0-10 Numeric Rating Scale
Patient pain scores will be assessed between all groups.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2014
- Study completionApr 2014
Why it stopped: Change in Regulatory Status
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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles M. Zelen, DPM, Principal investigator, Professional Education and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996111
- Sponsor's protocol ID
- AIPF003
- Acronym
- dHACM
- Status last verified
- Jun 2014
- First submitted
- 10 Oct 2013
- Last updated
- 13 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Blinded, Comparative Study of Dehydrated Human Amnion/Chorion Membrane Micrografts(dHACM) Injectable in the Treatment of Recalcitrant Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT01996111
- Acronym / sponsor ID
- dHACM / AIPF003
- Conditions
- Plantar Fasciitis
- Keywords
- plantar fasciitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in Regulatory Status
- Enrolment
- 14 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 27 Nov 2013 (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.
This is a prospective, controlled, randomized, blinded and comparative, single-center clinical trial comparing the improvement of patients with recalcitrant plantar fasciitis symptoms that have received standard of care versus treatment with differing amounts of injectable dehydrated human amnion/chorion membrane micrografts(dHACM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| • Group 2: | Experimental | Procedure: Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspensionInjection of 1.0 cc of 10 mg/ml micrograft dHACM suspension |
| • Group 3: | Experimental | Procedure: Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspensionInjection of 1.0 cc of 20 mg/ml micrograft dHACM suspension |
| • Group 4: | Experimental | Procedure: Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspensionInjection of 1.0 cc of 40 mg/ml micrograft dHACM suspension |
| • Group 1 | Placebo comparator | Procedure: Injection of 1.0 cc of 0.9% Saline• Injection of 1.0 cc of 0.9% Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- At least 18 years old.
- Both male and female patients will be selected.
- Plantar fasciitis has been treated with conservative usual care for at least 8 weeks, including at least three of the following modalities
- Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
- Patient understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
Key exclusion criteria (23 listed)
- Prior surgery at the site.
- Site that exhibits clinical signs and symptoms of infection.
- History of chronic plantar fasciitis of more than twelve months.
- Evidence of significant neurological disease of the feet.
- Non-ambulatory patients.
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 |
|---|---|---|
| Injection of 1.0 cc of 0.9% SalineInjection of 1.0 cc of 0.9% Saline into affected area | Procedure or surgery | • Group 1 |
| Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspensionInjection of 1.0 cc of 10 mg/ml micrograft dHACM suspension into affected area | Procedure or surgery | • Group 2: |
| Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspensionInjection of 1.0 cc of 20 mg/ml micrograft dHACM suspension into affected area | Procedure or surgery | • Group 3: |
| Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspensionInjection of 1.0 cc of 40 mg/ml micrograft dHACM suspension into affected area | Procedure or surgery | • Group 4: |
Primary outcome
Reduction of inflammation as measured by AOFAS Hindfoot scores
Time frame: 8 Weeks
The primary objective of this study is to compare the efficacy of the different treatment amounts in reduction of inflammation as measured by AOFAS Hindfoot scores.
2 secondary outcomes
Return to normal activities more quickly than with standard of care
Time frame: 8 Weeks
Pain as measured by 0-10 Numeric Rating Scale
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Change in Regulatory Status). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2014.
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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.
Charles M. Zelen, DPM principal investigator
Professional Education and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of 1.0 cc of 0.9% Saline, Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension and Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension in people with Plantar Fasciitis, run by MiMedx Group, 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 11 inclusion and 23 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: stopped early, as of the sponsor's last update on 13 Jun 2014. 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 was stopped early (reason given: Change in Regulatory Status). 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?
Reduction of inflammation as measured by AOFAS Hindfoot scores (time frame: 8 Weeks). 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 13 Jun 2014; AzTrials last refreshed its copy on 6 Nov 2026.