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Compression therapy of leg ulcers with PAOD

2014; SAGE Publishing; Volume: 29; Issue: 1_suppl Linguagem: Inglês

10.1177/0268355514529507

1758-1125

Andrea Ladwig, Hermann Haase, Jens Bichel, Jan Schuren, Michael Jünger,

Peripheral Artery Disease Management

Objectives: To assess the clinical safety of a new short-stretch 2-layer compression system (3Mtm Cobantm 2 Lite) in patients with peripheral arterial occlusive disease (PAOD). This system combines a low resting pressure with a high working pressure. Methods: A pilot study was performed in 15 subjects with moderate PAOD, i.e. an ABPI of 0.5-0.8. Co-existing chronic venous insufficiency or leg ulcer was not mandatory. All subjects received the compression system which was reapplied at each study visit (days 1, 2, 3, 4, 7, 10, 14). The safety parameters were: sub-bandage pressure immediately after application, pressure-related skin damage, hypoxia-related pain, and adverse events. A product comfort questionnaire was completed at the last visit. Results: The average sub-bandage pressure of 30 mmHg defined by the protocol was achieved. No pressure-related skin damage or hypoxia-related pain was found. The reported adverse device effects were as expected for compression therapies, including dry skin and pruritus. The product comfort questionnaire completed by the subjects showed a good tolerability profile. Conclusion: The short-stretch 2-layer compression system (3Mtm Cobantm 2 Lite) was safe and well tolerated in subjects with moderate PAOD.