NCT03903692

A Comparative Evaluation of a MPS Dressing and a CMC Dressing on Subjects With Lower Extremity Venous Ulcers

A Comparative Evaluation of a Marine Polysaccharide (MPS) Dressing and a Carboxymethylcellulose (CMC) Dressing on Subjects With Lower Extremity Venous Ulcers

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Medline Industries · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Venous leg ulcers are lower extremity ulcers that develop due to sustained venous hypertension resulting from chronic venous insufficiency. Varicose veins, deep vein thrombosis, poor calf muscle function, arterio-venous fistulae, obesity and history of leg fracture are some of the risk factors for venous ulceration. Numerous dressing types exist to treat these ulcers. This study will compare a marine polysaccharide (MPS) dressing to a carboxymethylcellulose dressing to determine which dressing better manages these wounds with regard to wound size and periwound skin condition. Subjects will be randomized to receive either MPS-Ag dressing or CMC-Ag dressing.

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
DEVICE	Marine polysaccharide dressing	The MPS-Ag dressing used in this study has a unique gelling action which helps to remove dead, damaged, and infected tissues from the wound by trapping and removing them later at dressing changes. It is designed to provide intimate contact with the wound for gentle healing. It also contains ionic silver.
DEVICE	Carboxymethylcellulose dressing	The CMC-Ag dressing used in this study incorporates two technologies to help eliminate the key barriers to healing that are exudate, infection, and bioburden. It can be used on chronic and acute wounds that are infected or at risk of infection with varying exudate levels.

Timeline

• Start date: 2019-09-30
• Primary completion: 2022-12-21
• Completion: 2022-12-21
• First posted: 2019-04-04
• Last updated: 2024-06-25
• Results posted: 2024-06-25

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study