A prospective, comparative, randomised study to compare the effects on ulcer healing of AQUACEL® Ag dressing when used for 4 weeks followed by treatment with AQUACEL® for 4 weeks to Urgotul® Silver dressing followed by Urgotul® for 4 weeks on subjects with venous leg ulcers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
266
AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks.
Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks.
Wound area reduction from baseline (relative)
Time frame: 8 weeks
Wound closure
Time frame: 8 weeks
Clinical evolution of the wound
presence of each of the 5 selected clinical signs
Time frame: 8 weeks
Tolerance
occurrence of local adverse events
Time frame: 8 weeks
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Arhus Universitets Hospital (#47)
Aarhus, Denmark
Bispebjerg Universitets Hospital (#45)
Copenhagen, Denmark
Odense Universitets Hospital (#46)
Odense, Denmark
(#35)
Paris, Neuilly Sur Siene, France
37 Bd Bury (#42)
Angoulême, France
CH de La Fere, (#44)
La Fère, France
Clinique des Augustines (#38)
Malestroit, France
19 rue des Clers (#37)
Metz, France
Hopital Brocca, 54/56 rue Pascal (#41)
Paris, France
Centre de Sante (#36)
Paris, France
...and 46 more locations