Physiotulle vs Urgotul in the Treatment of Leg Ulcer

Study Overview
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Brief Summary
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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.

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

Conditions
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Leg Ulcers

Intervention / Treatment
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* Device: Physiotulle
* Device: URGOTUL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physiotulle<br> | Device: Physiotulle<br>* Physiotulle is a non adherent dressing, composed of a polyester fabric impregnated with hydrocolloid particles (CMC) suspended in vaseline<br>|
| Placebo Comparator: Urgotul<br> | Device: URGOTUL<br>* Urgotul is an non occlusive dressing comprising of a polyester mesh impregnated with hydrocolloid particles dispersed on a petroleum jelly matrix<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain at dressing removal | pain at dressing removal assessed by the patient immediately after dressing removal on a VAS scale | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative reduction of the area of the leg ulcer measured by planimetry at final point at week 4 compared to the area at inclusion |  | 4weeks | 
| Number of patients with adverse events as a measure of safety and tolerability |  | 4 weeks |