Physiotulle vs Urgotul in the Treatment of Leg Ulcer

Clinical Assessment of Physiotulle Dressing Compared to Urgotul Dressing in the Treatment of Leg Ulcer

The aim of this study is to assess the pain at removal of Physiotulle dressing in comparison with that of Urgotul dressing in patients presenting a venous (or predominantly) venous leg ulcer.

Inclusion Criteria:

• Patient of either sex over 18 who have not been declared legally incompetent and who having given his written informed consent
• Patient with venous or predominantly venous leg ulcer (ankle-brachial index > 0.8)
• Patient with venous or predominantly venous leg ulcer in granulation phase (granulation tissue > 70 %)
• Patient with venous or predominantly venous leg ulcer with low exsudate
• Patient with venous or predominantly venous leg ulcer with a wound surface between 4 cm² and 170 cm²
• Patient with venous or predominantly venous leg ulcer that has been treated with an appropriate compression in the two weeks prior to inclusion
• Patient available to be monitored for at least 4 weeks
• Patient able to answer questionnaires and particularly to evaluate his pain

Exclusion Criteria:

• Patient whose leg ulcer is locally infected (At least 3 of 5 clinical signs suggestive of infection *)* 5 signs suggestive of infection: pain, exsudate, smell, oedema, erythema
• Patient requiring an analgesic treatment for the care (before dressing removal)
• Patient whose ulcer belongs to angiodermatitis type or demonstrates a vasculitis
• Patient with arterial ulcer
• Patient with purely traumatic, infectious or neoplastic origin ulcer
• Patient with a diabetic neuropathy of lower limbs
• Patient with a known allergy to one of Physiotulle or Urgotul components
• Patient already participating in another clinical study
• Pregnant or breastfeeding patient

Patient who have been taking corticoids > 10mg / day or cytostatics by systematic way for the three months prior to inclusion

Patient who have undergone surgery of saphenous trunk in the two months prior to inclusion