Clinical trial NCT01238419: Physiotulle vs Urgotul in the Treatment of Leg Ulcer
Official title: Clinical Assessment of Physiotulle Dressing Compared to Urgotul Dressing in the Treatment of Leg Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Leg Ulcers
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2010-11-10
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: pain at dressing removal
timeFrame: 4 weeks
Secondary outcomes:
measure: Relative reduction of the area of the leg ulcer measured by planimetry at final point at week 4 compared to the area at inclusion
timeFrame: 4weeks
measure: Number of patients with adverse events as a measure of safety and tolerability
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bispebjerg
country: Denmark
facility: Bispebjerg ^Hospital
state: NV
city: Arhus
country: Denmark
facility: Arhus Sygehus
city: Odense
country: Denmark
facility: Odense Universitets Hospital
city: Abbeville
country: France
facility: Cabilet Medical
city: Amiens
country: France
facility: CHU Sud
city: Angouleme
country: France
facility: Cabinet Medical
city: Arras
country: France
facility: Centre Hospitalier
city: Bagnoles de L'Orne
country: France
facility: Cabinet Médical
city: Brest
country: France
facility: CHU
city: Caen
country: France
facility: CHU
city: Charlevilles Mézières
country: France
facility: Hôpital Manchester
city: Douai
country: France
facility: Centre Hospitalier de Douai
city: Foix
country: France
facility: CHIVA
city: Freyming Merleback
country: France
facility: Hôpital de Freyming
city: Haguenau
country: France
facility: Centre Hospitalier
city: Issy les Moulineaux
country: France
facility: Hôpital Corention Celton
city: La Roche sur Yon
country: France
facility: CHD Les Oudairies
city: Le Mans
country: France
facility: CH Le Mans
city: Lille
country: France
facility: Cabinet Medical
city: Limoges
country: France
facility: Hôpital Dupuytren
city: Luneville
country: France
facility: Cabinet Médical
city: Montivilliers
country: France
facility: Hôpital jacques Monod
city: Nimes
country: France
facility: CHU Caremeau
city: Paris
country: France
facility: Hôpital lariboisiere
city: Poitiers
country: France
facility: CHRU La Miletrie
city: Quimper
country: France
facility: CH Cornouailles
city: Rouen
country: France
facility: Clinique Mathilde
city: Saint Gaudens
country: France
facility: Hôpital de Saint Gaudens
city: Saint Germain en Laye
country: France
facility: Centre hospitalier intercommunal
city: Sarrebourg
country: France
facility: Cabinet Medical
city: Toulon
country: France
facility: HIA Sainte Anne
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: CHRU Tours
city: Valenciennes
country: France
facility: CH
Study officials:
References: