NCT05632250

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.

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: ConvaTec Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of Chronic leg ulcers (including diabetic foot ulcers) and Pressure Injuries (Grade II and above)

Conditions

• Chronic Ulcer of Leg or Foot
• Pressure Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-10
• Primary completion: 2024-03-13
• Completion: 2024-03-13
• First posted: 2022-11-30
• Last updated: 2024-04-30

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study