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

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: Terminated
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Procedure: Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension; Procedure: Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension; Procedure: Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension; Procedure: Injection of 1.0 cc of 0.9% Saline

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	8 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 Weeks
Pain as measured by 0-10 Numeric Rating Scale	Patient pain scores will be assessed between all groups.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 weeks

Collaborators and Investigators

• Sponsor: MiMedx Group, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: October 10, 2013
• First Submitted That Met QC Criteria: November 21, 2013
• First Posted (ESTIMATE): November 27, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 13, 2014
• Last Update Submitted That Met QC Criteria: June 12, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: plantar fasciitis
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: AIPF003