NCT04088383

Brief Summary

The purpose of this study is to evaluate clinical outcomes of patients with plantar fasciitis following treatment with Amnios™ RT. Patients will be randomized to either Amnios™ RT or a placebo control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

3.2 years

First QC Date

September 11, 2019

Last Update Submit

February 22, 2023

Conditions

Plantar Fasciitis

Outcome Measures

Primary Outcomes (2)

  • Visual Analog Scale (VAS) Foot Pain Score

    The visual analog scale (VAS) is a patient questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with "no pain" on the left border and "most intense pain imaginable" on the right border. The subject is instructed to place a vertical line on the scale that indicates the pain severity experienced; 0mm is equal to no pain and 100mm is most intense pain imaginable. Study staff records the distance of the patient's mark on the scale in millimeters.

    3 Months

  • Serious Adverse Events

    The occurrence of serious adverse events that are related to the product.

    12 Months

Study Arms (2)

Amnios™ RT

OTHER
Other: Amnios™ RT

Saline

PLACEBO COMPARATOR
Other: Saline

Interventions

Amnios™ RTOTHER

Acellular human allograft

Amnios™ RT
SalineOTHER

Sterile saline

Saline

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of unilateral plantar fasciitis for ≥ 1 month (30 days) and ≤ 18 months by the Investigator
  • VAS Foot Pain score of at least 45mm (out of 100mm scale) at randomization
  • Plantar fasciitis with conservative treatment for ≥ 1 month (30 days), including any of the following modalities:
  • RICE
  • Stretching exercises
  • NSAIDs
  • Orthotics
  • Diagnostic radiograph within 6 months of enrollment showing view of calcaneus, without evidence of calcaneal fracture or structural abnormalities
  • BMI ≤ 40 kg/m2
  • Age ≥ 18 years and \< 80 years
  • Willing and able to comply with the follow-up requirements of the protocol
  • Signed an Informed Consent Form specific to this research and agreed to release of medical information

You may not qualify if:

  • Prior surgery or trauma resulting in severe, permanent damage to the affected foot
  • Require bilateral plantar fasciitis treatment at time of enrollment (with exception of compensatory symptoms on the non-affected foot)
  • Prior use of any lower limb injection therapy, including corticosteroids or PRP in either foot within the last 3 months
  • Has Type I or Type II diabetes mellitus
  • Systemic disorders associated with enthesopathy (disorder of entheses, i.e. bone attachments) such as Gout, reactive arthritis, rheumatoid arthritis, etc.
  • The presence of diagnosed comorbidities that can be confused with or can exacerbate the condition (as assessed by radiograph) including:
  • Calcaneal stress fracture
  • Nerve entrapment syndrome (diagnosed as Baxter Nerve Syndrome)
  • Fat pad atrophy (relative to expectations for patient's age)
  • 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
  • Other malignant tumors in the foot or conditions that may affect study outcomes
  • Affected site exhibits clinical signs and symptoms of infection of the foot in question
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bio-X-Cell Research

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2019

First Posted

September 12, 2019

Study Start

September 10, 2019

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

February 23, 2023

Record last verified: 2023-02

Locations

US(1)