MedTrace Logo

Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-Layer to Standard of Care

NCT03626623 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-08-25

Study results available
· View outcomes & findings →

Summary

This is a two-armed randomized controlled trial (RCT) primarily aimed at determining if application of Cytal Wound Matrix 1-Layer intervention to diabetic foot ulcers shows improved wound closure rates when compared to standard care intervention.

Conditions

  • Diabetes
  • Diabetic Foot
  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Cytal Wound Matrix 1-Layer

Cytal® Wound Matrix 1-Layer is composed of a porcine (pig) derived extracellular matrix known as urinary bladder matrix. It is intended for the management of a variety of wounds.The individual device is intended for one time use.

OTHER

Standard of Care (SOC)

Standard of care (SOC) is defined as the usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds. SOC associated procedures and policies may vary across clinical settings.

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Allison Matthews · Integra LifeSciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-21
Primary Completion
2020-02-18
Completion
2020-02-18
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03626623 on ClinicalTrials.gov