Physiotulle vs Urgotul in the Treatment of Leg Ulcer

• Relative reduction of the area of the leg ulcer measured by planimetry at final point at week 4 compared to the area at inclusion [ Time Frame: 4weeks ] [ Designated as safety issue: No ]
• Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

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.

• Device: Physiotulle
  Physiotulle is a non adherent dressing, composed of a polyester fabric impregnated with hydrocolloid particles (CMC) suspended in vaseline
• Device: URGOTUL
  Urgotul is an non occlusive dressing comprising of a polyester mesh impregnated with hydrocolloid particles dispersed on a petroleum jelly matrix

• Experimental: Physiotulle
  Intervention: Device: Physiotulle
• Placebo Comparator: Urgotul
  Intervention: Device: URGOTUL

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