NCT03626623

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

A Prospective, Randomized, Controlled Trial Comparing Cytal Wound Matrix 1-Layer to Standard of Care (SOC) in the Management of Diabetic Foot Ulcers (DFUs)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, two-armed, multi-center randomized controlled trial (RCT) comparing Cytal Wound Matrix 1-Layer intervention to standard of care (SOC) intervention in patients presenting with diabetic foot ulcers (DFU). Up to one hundred and fifty patients recruited from US based medical centers and randomized (using a 2(active):1(control) randomization scheme) to receive either Cytal Wound Matrix 1-Layer intervention or standard of care intervention.Complete wound closure incidence, wound healing rates, wound recurrence, and various health related quality of life (HRQOL) outcomes will be compared between study arms. Additionally, a cost effective analysis (i.e. direct and indirect costs) and review of individual and group changes in narcotic prescription patterns will also be evaluated. While incidence of wound closure rates will be evaluated through 12 weeks, protocol defined patient follow-up is for two years. Data will be captured for remaining study objectives during these two years. An independent biostatistician will review all participant data for power and futility analysis. In addition, a clinical events committee (CEC) will adjudicate all adverse events (AEs) and serious adverse events (SAEs).

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-05-21
• Primary completion: 2020-02-18
• Completion: 2020-02-18
• First posted: 2018-08-13
• Last updated: 2021-08-25
• Results posted: 2021-02-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study