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Efficacy and Safety of MedifoamⓇ and BetafoamⓇ in Pressure Ulcer

Pressure Ulcer Clinical Trial

Official title:
A Pilot Study to Evaluate Efficacy and Safety of Hydrophilic Polyurethane Foam Dressing in Patients With Pressure Ulcer

Clinical Trial Summary

This study aims to exploratively assess the efficacy and safety of hydrophilic polyurethane foam dressing (MedifoamⓇ or BetafoamⓇ) in pressure ulcer specifically. The target enrolment is 20 patients, with 10 patients per arm.

Clinical Trial Description

As the primary objective, the percentage of completely healed patients and the time to complete healing will be assessed after applying the study device, MedifoamⓇ or BetafoamⓇ, for 12 weeks to pressure ulcer patients. In addition, the pressure ulcer size reduction rate over 12 weeks will be evaluated.

Patients will make once weekly site visits. There are 14 visits in total, including a screening visit 14 days (maximum) before the baseline visit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02863263
Study type Interventional
Source Mundipharma Pte Ltd.
Contact
Status Terminated
Phase N/A
Start date July 29, 2016
Completion date July 26, 2017
View Details
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