Status:
COMPLETED
Physiotulle vs Urgotul in the Treatment of Leg Ulcer
Lead Sponsor:
Coloplast A/S
Conditions:
Leg Ulcers
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2011
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT01238419
Start Date
November 1 2009
End Date
May 1 2011
Last Update
September 5 2011
Active Locations (34)
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1
Bispebjerg ^Hospital
Bispebjerg, NV, Denmark, 2400
2
Arhus Sygehus
Aarhus, Denmark, 8000
3
Odense Universitets Hospital
Odense, Denmark, 5000
4
Cabilet Medical
Abbeville, France, 80100