Registry of Amniotic Membrane: Evaluating Utilization and Outcomes in Various Applications

Completed

• Conditions: Wound; Orthopedic Disorder

• Registration Number: NCT04222166
• Lead Sponsor: MED Institute Inc.

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.

Detailed Description

The objective of this registry is to collect outcomes data via a registry on the uses of CAM in the post-market setting, including:

* Adverse events related to the treatment, or the product, will be collected for up to 12 weeks following the treatment.

* Improvements in appropriate effectiveness markers for CAM use in patients treated for various conditions.

* Improvements in overall quality of life resulting from CAM treatment in patients.

An additional objective is to determine standard of care follow-up for the target treatments, including effectiveness metrics used and typical follow-up schedule.

This registry is intended to collect clinical data from patients for analysis purposes only and will not be used to treat patients. The plan does not allow for any deviation from standard of care practice. Therefore, there is no added risk to patients from participating in the registry.

The sponsor will use an electronic data capture (EDC) system for capturing all the data from the sites. The system will be built and validated prior to initiation of the sites. Each participating physician or appropriately trained designee shall enter data into the EDC system, providing all applicable data and documentation to the sponsor. Data will be reviewed for missing data, data consistency, and reasonableness of responses. Discrepancies will be resolved through a formal query process within the EDC system, and may involve direct contact with hospital staff.

The conduct of the registry will be supervised through a process of centralized and on-site monitoring. The sponsor may remotely monitor the registry for data completeness and for adverse events. On-site monitoring will be implemented as necessary throughout the course of the registry. The physician/clinic will provide direct access to source data/documents for registry-related monitoring, audits and IRB review.

Study Timeline

• Study Start: 2019-12-16
• Study First Submitted: 2020-01-03
• Study First Submitted QC: 2020-01-06
• Study First Posted: 2020-01-09
• Primary Completion: 2021-06-30
• Status Verified: 2021-08
• Study Completion: 2021-08-06
• Last Update Submitted: 2021-08-26
• Last Update Posted: 2021-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of related serious adverse events	12 weeks	Number of related serious adverse events occurred

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale	12 weeks	Change in pain score (0-10; higher scores mean worse outcome)
Change in wound size	12 weeks	Change in wound size
Change in analgesic use	12 weeks	Change in analgesic use
Time to complete wound closure	12 weeks	Time to complete wound closure

Trial Locations

Locations (2)

Regenerative Medicine and Pain Management Physicians; 🇺🇸 Gulf Breeze, Florida, United States

Foot and Ankle Specialists of South Jersey; 🇺🇸 Voorhees, New Jersey, United States