Micronized dHACM Injectable for the Treatment of Plantar Fasciitis

NCT02427191 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: AIPF004
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 11

Brief Summary

Prospective, single-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis

Conditions

Fasciitis, Plantar

Keywords

Chronic plantar fasciitis; Heel pain

Outcome Measures

Primary Outcomes (2)

• 20% improvement over baseline Visual Analog Scale for Pain

  Visual Analog Scale

  3 Months

• Incidence of adverse events

  Review AE at every visit

  12 months

Secondary Outcomes (5)

• 20% improvement in Foot Function Index-Revised (FFI-R) score from baseline

  3 months

• Blood sample analysis for immuno-compatibility of first 20 patients in each treatment arm

  3 and 12 months

• Long-term FFI-R outcomes

  6 and 12 months

• Long-term Visual Analog Scale (VAS) Pain outcomes

  6 and 12 months

• Long-term blood sample analysis for immuno-compatibility of first 20 patients in each treatment arm

  6 and 12 months

Study Arms (2)

AmnioFix® Injectable

EXPERIMENTAL

1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)

Other: AmnioFix® Injectable

Saline Injection

PLACEBO COMPARATOR

Injection of 1mL 0.9% Sodium Chloride Injection, USP

Drug: Saline Injection

Interventions

AmnioFix® Injectable OTHER

1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)

Also known as: dHACM

AmnioFix® Injectable

Saline Injection DRUG

Injection of 1mL 0.9% Sodium Chloride Injection, USP

Also known as: 0.9% NaCl, Normal Saline

Saline Injection

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of plantar fasciitis for ≥ 1 month (30 days) and ≤ 18 months by the investigator
• VAS Pain scale of ≥ 45 mm at randomization
• Plantar fasciitis with conservative treatment for ≥ 1 month (30 days), including any of the following modalities:
• RICE
• Stretching exercises
• NSAIDs
• Orthotics
• Diagnostic X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities
• BMI ≤ 40 kg/m2
• Age ≥ 21 years and \< 80
• Ability to sign Informed Consent and Release of Medical Information Forms

You may not qualify if:

• Prior surgery or trauma to the affected site
• Subjects requiring bilateral plantar fasciitis treatment at time of enrollment
• Prior use of any lower limb injection therapy, including corticosteroids or PRP in either limb within the last 3 months
• Has diabetes either Type I or Type II
• Systemic disorders associated with enthesopathy (disorder of entheses, i.e. bone attachments) such as Gout, Reiter's syndrome, rheumatoid arthritis, etc.
• The presence of comorbidities that can be confused with or can exacerbate the condition- to be assessed by X-ray - including but not limited to:
• Calcaneal stress fracture
• Nerve entrapment syndrome (Baxter Nerve Syndrome)
• Fat pad atrophy
• Acute traumatic rupture of the plantar fascia
• Calcaneal tumor
• Tarsal tunnel syndrome
• Significant bone deformity of the foot that may interfere with the study
• Affected site exhibits clinical signs and symptoms of infection
• Known allergy or known sensitivity to Aminoglycosides, such as Gentamicin sulfate or Streptomycin sulfate

Sponsors & Collaborators

• MiMedx Group, Inc.: lead

Study Sites (11)

Southern Arizona VA Health Care System

Tucson, Arizona, 85723, United States

Location

Limb Preservation Platform, Inc.

Fresno, California, 93721, United States

Location

Center for Clinical Research, Inc.

San Francisco, California, 94115, United States

Location

Orlando VA Healthcare System

Orlando, Florida, 32803, United States

Location

Edward Hines Jr. Veterans Administration Hospital

Chicago, Illinois, 60141, United States

Location

James A. Lovell Federal Health Care Center

North Chicago, Illinois, 60064, United States

Location

Timonium Foot and Ankle Center

Baltimore, Maryland, 21093, United States

Location

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

WJB Dorn VA Medical Center

Columbia, South Carolina, 29209, United States

Location

Scott & White Healthcare

Temple, Texas, 76508, United States

Location

Coastal Podiatry Group

Virginia Beach, Virginia, 23464, United States

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Stuart D Miller, MD

  MedStar Union Memorial Hospital, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: April 27, 2015
• Study Start: March 31, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

US (11)