Dehydrated Human Amnion/Chorion Membrane Micrografts(dHACM) Injectable in the Treatment of Recalcitrant Plantar Fasciitis (dHACM)

June 12, 2014 updated by: MiMedx Group, Inc.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24016
        • Professional Education and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. At least 18 years old.
  2. Both male and female patients will be selected.

  3. 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
    • Non-steroidal Anti-Inflammatory Drugs (NSAIDs)
    • Orthotics
  4. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
  5. Patient understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
  6. Patient has read and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.

Exclusion Criteria

  1. Prior surgery at the site.
  2. Site that exhibits clinical signs and symptoms of infection.
  3. History of chronic plantar fasciitis of more than twelve months.
  4. Evidence of significant neurological disease of the feet.
  5. Non-ambulatory patients.

  6. The presence of comorbidities that can be confused with or can exacerbate the condition including:

    • 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
  7. 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.
  8. Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
  9. History of radiation therapy at the site.
  10. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
  11. Study foot has been previously treated with tissue engineered materials within the last 30 days.
  12. Patients who are unable to understand the aims and objectives of the trial.
  13. 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.
  14. Pregnant or breast feeding. No pregnancy within the past 6 months.
  15. Allergy to Gentamicin and/or Streptomycin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: • Group 2:
Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension
Procedure: Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension
Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension into affected area
EXPERIMENTAL: • Group 3:
Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension
Procedure: Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension
Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension into affected area
EXPERIMENTAL: • Group 4:
Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension
Procedure: Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension
Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension into affected area
PLACEBO_COMPARATOR: • Group 1
• Injection of 1.0 cc of 0.9% Saline
Procedure: Injection of 1.0 cc of 0.9% Saline
Injection of 1.0 cc of 0.9% Saline into affected area

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
8 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Return to normal activities more quickly than with standard of care
Time Frame: 8 Weeks
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.
8 Weeks
Pain as measured by 0-10 Numeric Rating Scale
Time Frame: 12 weeks
Patient pain scores will be assessed between all groups.
12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life as measured by SF-36
Time Frame: 8 weeks
SF-36 scores between all groups before and after treatment over a period of eight weeks. Physical Component Score (PCS) and Mental Component Score (MCS) will be evaluation at 8 weeks and compared to baseline
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MiMedx Group, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AIPF003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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