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

NCT01996111 | Terminated

• 1 other identifier: AIPF003
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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).

Conditions

Plantar Fasciitis

Keywords

plantar fasciitis

Outcome Measures

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.

  8 Weeks

Secondary Outcomes (2)

• Return to normal activities more quickly than with standard of care

  8 Weeks

• Pain as measured by 0-10 Numeric Rating Scale

  12 weeks

Other Outcomes (1)

• Quality of Life as measured by SF-36

  8 weeks

Study Arms (4)

• Group 2:

EXPERIMENTAL

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

• Group 3:

EXPERIMENTAL

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

• Group 4:

EXPERIMENTAL

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

• Group 1

PLACEBO COMPARATOR

• Injection of 1.0 cc of 0.9% Saline

Procedure: Injection of 1.0 cc of 0.9% Saline

Interventions

Injection of 1.0 cc of 0.9% Saline PROCEDURE

Injection of 1.0 cc of 0.9% Saline into affected area

• Group 1

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 into affected area

• Group 2:

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 into affected area

• Group 3:

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 into affected area

• Group 4:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MiMedx Group, Inc.: lead

Study Sites (1)

Professional Education and Research Institute

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Charles M. Zelen, DPM

  Professional Education and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: November 27, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 13, 2014

Record last verified: 2014-06

Locations

US (1)