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TerminatedNCT01996111dHACMUpdated Jun 13, 2014

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

An interventional study of Injection of 1.0 cc of 0.9% Saline and Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension in Plantar Fasciitis, sponsored by MiMedx Group, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-13.

Sponsored by MiMedx Group, Inc. · Not applicable, Interventional, and Treatment

Why this study was terminated
Change in Regulatory Status
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Plantar Fasciitis

Keywords

  • plantar fasciitis
03

In context

Fasciitis

235 studies on the registry are indexed under Fasciitis; 37 are open to participants now.

This study's enrollment of 14 is below the median of 54 across 192 interventional studies indexed under Fasciitis.

Browse Fasciitis studies →

Lead sponsor

MiMedx Group, Inc. is the lead sponsor of 35 studies on the registry; 2 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
14 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • Placebo comparator
    • Group 1

    • Injection of 1.0 cc of 0.9% Saline

    Procedure: Injection of 1.0 cc of 0.9% Saline

Interventions

  • ProcedureInjection of 1.0 cc of 0.9% Saline

    Injection of 1.0 cc of 0.9% Saline into affected area

  • ProcedureInjection 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

  • ProcedureInjection 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

  • ProcedureInjection 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 Weeks

Secondary outcomes

  1. 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.

    Time frame: 8 Weeks

  2. Pain as measured by 0-10 Numeric Rating Scale

    Patient pain scores will be assessed between all groups.

    Time frame: 12 weeks

Other outcomes

  1. Quality of Life as measured by SF-36

    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

07

Study locations

1 site
  • Professional Education and Research Institute
    Roanoke, Virginia 24016, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01996111
Lead sponsor
MiMedx Group, Inc.
Responsible party
Sponsor
First posted
Nov 27, 2013
Start date
Sep 2013
Primary completion
Mar 2014
Completion
Apr 2014
Last update
Jun 13, 2014

Study contacts

Charles M. Zelen, DPM
principal investigator · Professional Education and Research Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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