NCT04902612

HM242-Solution vs Comparator

Prospective, Controlled, Randomized, Double-blind, Premarket Multi-centre Study on the Performance of HM242-Solution vs Comparator in Patients Under Condition of Venous Leg Ulcer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: B. Braun Ltd. Centre of Excellence Infection Control · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objectives of this study include investigating the performance of HM242-Solution compared to normal Saline with respect to venous leg ulcer healing. Saline is widely used for venous leg ulcer cleansing and has served as comparator or standard treatment in clinical trials evaluating new cleansing products to prove that it is as good as the standard treatment. Data will also be collected on the patients' quality of life and any adverse events that may arise during the study.

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
DEVICE	HM242-Solution	HM242-Solution compared to Saline compared in patients with a venous leg ulcer
DEVICE	Saline	HM242-Solution compared to Saline compared in patients with a venous leg ulcer

Timeline

• Start date: 2021-05-25
• Primary completion: 2022-10-01
• Completion: 2022-12-01
• First posted: 2021-05-26
• Last updated: 2021-11-22

Locations

2 sites across 1 country: Italy