Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
188 participants
INTERVENTIONAL
2009-11-30
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Physiotulle
Physiotulle
Physiotulle is a non adherent dressing, composed of a polyester fabric impregnated with hydrocolloid particles (CMC) suspended in vaseline
Urgotul
URGOTUL
Urgotul is an non occlusive dressing comprising of a polyester mesh impregnated with hydrocolloid particles dispersed on a petroleum jelly matrix
Interventions
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Physiotulle
Physiotulle is a non adherent dressing, composed of a polyester fabric impregnated with hydrocolloid particles (CMC) suspended in vaseline
URGOTUL
Urgotul is an non occlusive dressing comprising of a polyester mesh impregnated with hydrocolloid particles dispersed on a petroleum jelly matrix
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Coloplast A/S
INDUSTRY
Responsible Party
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Locations
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Bispebjerg ^Hospital
Bispebjerg, NV, Denmark
Arhus Sygehus
Aarhus, , Denmark
Odense Universitets Hospital
Odense, , Denmark
Cabilet Medical
Abbeville, , France
CHU Sud
Amiens, , France
Cabinet Medical
Angoulême, , France
Centre Hospitalier
Arras, , France
Cabinet Médical
Bagnoles-de-l'Orne, , France
CHU
Brest, , France
CHU
Caen, , France
Hôpital Manchester
Charlevilles Mézières, , France
Centre Hospitalier de Douai
Douai, , France
CHIVA
Foix, , France
Hôpital de Freyming
Freyming Merleback, , France
Centre Hospitalier
Haguenau, , France
Hôpital Corention Celton
Issy-les-Moulineaux, , France
CHD Les Oudairies
La Roche-sur-Yon, , France
CH Le Mans
Le Mans, , France
Cabinet Medical
Lille, , France
Hôpital Dupuytren
Limoges, , France
Cabinet Médical
Lunéville, , France
Hôpital jacques Monod
Montivilliers, , France
CHU Caremeau
Nîmes, , France
Hôpital lariboisiere
Paris, , France
CHRU La Miletrie
Poitiers, , France
CH Cornouailles
Quimper, , France
Clinique Mathilde
Rouen, , France
Hôpital de Saint Gaudens
Saint-Gaudens, , France
Centre hospitalier intercommunal
Saint-Germain-en-Laye, , France
Cabinet Medical
Sarrebourg, , France
HIA Sainte Anne
Toulon, , France
Clinique Pasteur
Toulouse, , France
CHRU Tours
Tours, , France
CH
Valenciennes, , France
Countries
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Other Identifiers
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FR010WS
Identifier Type: -
Identifier Source: org_study_id
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