NCT04222166

Brief Summary

This registry will assess clinical outcomes following the use of Cryopreserved Amniotic Membrane (CAM) for the treatment of orthopedic and various other conditions. This registry will collect outcomes data via a registry of up to 100 patients who have received treatment with CAM in the post-market setting. Patients will be enrolled from up to five healthcare centers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

2 active sites

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

December 16, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2021

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

January 3, 2020

Last Update Submit

August 26, 2021

Conditions

Orthopedic DisorderWound

Outcome Measures

Primary Outcomes (1)

  • Incidence of related serious adverse events

    Number of related serious adverse events occurred

    12 weeks

Secondary Outcomes (4)

  • Visual Analog Scale

    12 weeks

  • Change in analgesic use

    12 weeks

  • Change in wound size

    12 weeks

  • Time to complete wound closure

    12 weeks

Interventions

CAMBIOLOGICAL

Cryopreserved Amniotic Membrane

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A patient is suitable for inclusion in this registry if the patient has been treated with CAM for any indication as per the standard of care practice.

You may not qualify if:

  • Patients are excluded from registry enrollment if they are under the age of 22 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Regenerative Medicine and Pain Management Physicians

Gulf Breeze, Florida, 32563, United States

Location

Foot and Ankle Specialists of South Jersey

Voorhees Township, New Jersey, 08043, United States

Location

MeSH Terms

Conditions

Musculoskeletal DiseasesWounds and Injuries

Study Officials

  • Theodore Heise, PhD

    MED Institute Inc.

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
12 Weeks
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2020

First Posted

January 9, 2020

Study Start

December 16, 2019

Primary Completion

June 30, 2021

Study Completion

August 6, 2021

Last Updated

August 27, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)