Last updated on September 2017

Efficacy and Safety of Medifoam and Betafoam in Pressure Ulcer

Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT02863263

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Valerie Leck

Seoul National University Hospital
Seoul, Korea, Republic of
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