A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Safety, and Performance of ConvaFoam™ Dressings in the Management of Indicated Chronic Wound Types.

NACompletedINTERVENTIONAL
Enrollment

95

Participants

Timeline

Start Date

April 10, 2023

Primary Completion Date

March 13, 2024

Study Completion Date

March 13, 2024

Conditions
Chronic Ulcer of Leg or FootPressure Injury
Interventions
DEVICE

ConvaFoam

ConvaFoam™ Border, ConvaFoam™ Non-Adhesive, and ConvaFoam™ Silicone dressings are designed to provide a moist wound healing environment. These dressings are designed to manage excess exudate levels which may further damage the wound bed and surrounding skin. Patient's wounds will be assessed and a dressing from the above will be applied as part of their normal standard of care. The wounds will be assessed on a weekly basis for up to 12 weeks.

Trial Locations (5)

11501

NYU Langone Health, Mineola

20006

Foot and Ankle Specialsts of the Mid-Atlantic, Raleigh

21742

Foot and Ankle Specialists of the Mid-Atlantic, Hagerstown

43606

ProMedica Toledo Hospital, Toledo

77504

Hope Vascularity & Podiatry, PLLC, Houston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ConvaTec Inc.

INDUSTRY