Micronized dHACM Injectable for the Treatment of Plantar Fasciitis
A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Plantar Fasciitis
1 other identifier
interventional
208
1 country
17
Brief Summary
Prospective, double-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2018
Typical duration for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 8, 2018
CompletedFirst Submitted
Initial submission to the registry
January 23, 2018
CompletedFirst Posted
Study publicly available on registry
January 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2021
CompletedMay 19, 2022
October 1, 2020
3.2 years
January 23, 2018
May 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in VAS score
Visual Analog Scale for Pain:
90 Days
Incidence of adverse events
The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events during the first 12 months post injection
180 Days
Secondary Outcomes (1)
Foot Function Index - Revised (FFI-R) (Short Form)
90 Days
Study Arms (2)
Micronized dHACM
EXPERIMENTAL1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)
Saline Injection
PLACEBO COMPARATORInjection of 1mL 0.9% Sodium Chloride Injection, USP
Interventions
1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)
Injection of 1mL 0.9% Sodium Chloride Injection, USP
Eligibility Criteria
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 years
- Ability to sign Informed Consent and Release of Medical Information Forms
- Ability to receive and respond to text messages or emails on a daily basis.
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 diagnosed 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 (diagnosed as Baxter Nerve Syndrome)
- Fat pad atrophy
- Acute traumatic rupture of the plantar fascia
- Calcaneal tumor
- Tarsal tunnel syndrome (diagnosed)
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Southern Arizona VA Health Care System
Tucson, Arizona, 85723, United States
ILD Research Center
Carlsbad, California, 92009, United States
Center for Clinical Research
Carmichael, California, 95608, United States
Limb Preservation Platform, Inc.
Fresno, California, 93721, United States
Horizon Clinical Research
La Mesa, California, 91942, United States
Foot and Ankle Clinic
Los Angeles, California, 90057, United States
Five Cities Foot Clinic
Pismo Beach, California, 93449, United States
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744, United States
Gulfcoast Research Institute, LLC
Sarasota, Florida, 34232, United States
Doctors Research Network
South Miami, Florida, 33143, United States
Union Podiatry
Baltimore, Maryland, 21218, United States
Advanced Foot & Ankle Center
Las Vegas, Nevada, 89119, United States
University Orthopedics Center
Altoona, Pennsylvania, 16602, United States
University Orthopedics Center
State College, Pennsylvania, 16801, United States
Futuro Clinical Trials, LLC
McAllen, Texas, 78501, United States
Endeavor Clinical Trials
San Antonio, Texas, 78229, United States
Coastal Podiatry
Virginia Beach, Virginia, 23464, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stuart D Miller, MD
MedStar Union Memorial Hospital, Baltimore, MD
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2018
First Posted
January 29, 2018
Study Start
January 8, 2018
Primary Completion
March 17, 2021
Study Completion
March 17, 2021
Last Updated
May 19, 2022
Record last verified: 2020-10