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

Primary Purpose

Plantar Fasciitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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
Sponsored by
MiMedx Group, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis focused on measuring plantar fasciitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Professional Education and Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

• Group 2:

• Group 3:

• Group 4:

• Group 1

Arm Description

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

• Injection of 1.0 cc of 0.9% Saline

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Pain as measured by 0-10 Numeric Rating Scale
Patient pain scores will be assessed between all groups.

Full Information

First Posted
October 10, 2013
Last Updated
June 12, 2014
Sponsor
MiMedx Group, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01996111
Brief Title
Dehydrated Human Amnion/Chorion Membrane Micrografts(dHACM) Injectable in the Treatment of Recalcitrant Plantar Fasciitis
Acronym
dHACM
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
Change in Regulatory Status
Study Start Date
September 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MiMedx Group, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 micrografts(dHACM).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
Keywords
plantar fasciitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
• Group 2:
Arm Type
Experimental
Arm Description
Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension
Arm Title
• Group 3:
Arm Type
Experimental
Arm Description
Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension
Arm Title
• Group 4:
Arm Type
Experimental
Arm Description
Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension
Arm Title
• Group 1
Arm Type
Placebo Comparator
Arm Description
• Injection of 1.0 cc of 0.9% Saline
Intervention Type
Procedure
Intervention Name(s)
Injection of 1.0 cc of 0.9% Saline
Intervention Description
Injection of 1.0 cc of 0.9% Saline into affected area
Intervention Type
Procedure
Intervention Name(s)
Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension
Intervention Description
Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension into affected area
Intervention Type
Procedure
Intervention Name(s)
Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension
Intervention Description
Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension into affected area
Intervention Type
Procedure
Intervention Name(s)
Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension
Intervention Description
Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension into affected area
Primary Outcome Measure Information:
Title
Reduction of inflammation as measured by AOFAS Hindfoot scores
Description
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.
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Return to normal activities more quickly than with standard of care
Description
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.
Time Frame
8 Weeks
Title
Pain as measured by 0-10 Numeric Rating Scale
Description
Patient pain scores will be assessed between all groups.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Quality of Life as measured by SF-36
Description
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
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles M. Zelen, DPM
Organizational Affiliation
Professional Education and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Professional Education and Research Institute
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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