Physiotulle vs Urgotul in the Treatment of Leg Ulcer
Clinical Assessment of Physiotulle Dressing Compared to Urgotul Dressing in the Treatment of Leg Ulcer
1 other identifier
interventional
188
2 countries
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2009
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 27, 2010
CompletedFirst Posted
Study publicly available on registry
November 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedSeptember 5, 2011
October 1, 2010
1.5 years
October 27, 2010
September 2, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
pain at dressing removal
pain at dressing removal assessed by the patient immediately after dressing removal on a VAS scale
4 weeks
Secondary Outcomes (2)
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
Study Arms (2)
Physiotulle
EXPERIMENTALUrgotul
PLACEBO COMPARATORInterventions
Physiotulle is a non adherent dressing, composed of a polyester fabric impregnated with hydrocolloid particles (CMC) suspended in vaseline
Urgotul is an non occlusive dressing comprising of a polyester mesh impregnated with hydrocolloid particles dispersed on a petroleum jelly matrix
Eligibility Criteria
You may qualify if:
- 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 available to be monitored for at least 4 weeks
- Patient able to answer questionnaires and particularly to evaluate his pain
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
Study Sites (34)
Bispebjerg ^Hospital
Bispebjerg, NV, 2400, Denmark
Arhus Sygehus
Aarhus, 8000, Denmark
Odense Universitets Hospital
Odense, 5000, Denmark
Cabilet Medical
Abbeville, 80100, France
CHU Sud
Amiens, 80054, France
Cabinet Medical
Angoulême, 16000, France
Centre Hospitalier
Arras, 62022, France
Cabinet Médical
Bagnoles-de-l'Orne, 61140, France
CHU
Brest, 29609, France
CHU
Caen, 14033, France
Hôpital Manchester
Charlevilles Mézières, 80011, France
Centre Hospitalier de Douai
Douai, 59507, France
CHIVA
Foix, 09000, France
Hôpital de Freyming
Freyming Merleback, 57804, France
Centre Hospitalier
Haguenau, 67504, France
Hôpital Corention Celton
Issy-les-Moulineaux, 92133, France
CHD Les Oudairies
La Roche-sur-Yon, 85925, France
CH Le Mans
Le Mans, 72000, France
Cabinet Medical
Lille, 59000, France
Hôpital Dupuytren
Limoges, 87042, France
Cabinet Médical
Lunéville, 54300, France
Hôpital jacques Monod
Montivilliers, 76290, France
CHU Caremeau
Nîmes, 30900, France
Hôpital lariboisiere
Paris, 75475, France
CHRU La Miletrie
Poitiers, 86021, France
CH Cornouailles
Quimper, 29107, France
Clinique Mathilde
Rouen, 76175, France
Hôpital de Saint Gaudens
Saint-Gaudens, 31806, France
Centre hospitalier intercommunal
Saint-Germain-en-Laye, 78105, France
Cabinet Medical
Sarrebourg, 57400, France
HIA Sainte Anne
Toulon, 83000, France
Clinique Pasteur
Toulouse, 31076, France
CHRU Tours
Tours, 37044, France
CH
Valenciennes, 59322, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2010
First Posted
November 10, 2010
Study Start
November 1, 2009
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
September 5, 2011
Record last verified: 2010-10