Objective: To evaluate the efficacy, tolerance and acceptability of Urgotul and DuoDERM E dressings
in the local management of venous or mixed-aetiology leg ulcers.
l Method: This was a prospective multicentre randomised phase IV clinical trial conducted open-label
in parallel groups. It involved 20 investigating centres, including hospital dermatology and vascular
medicine departments, and private practices. Dermatologists and angiologists/phlebologists took part.
Subjects were adult, non-immunosuppressed patients presenting with a non-infected, non-malignant leg
ulcer of predominantly venous origin (ABPI >0.8). Ulcers were between 4cm2 and 40cm2 in size, with
granulation tissue covering more than 50% of their surface area. Ulcer duration ranged from three to
18 months. Patients were followed-up by the investigating physician for eight weeks on a weekly basis;
this included clinical examination, wound area tracings and photographs. Nurses (hospital or visiting)
assessed exudate volume and clinical appearance at dressing changes.
l Results: Ninety-one patients were included: 47 in the Urgotul group and 44 in the DuoDERM E
group. Baseline patient demographic data and wound characteristics were comparable in the two groups.
After eight weeks of treatment wound surface area had reduced by a mean of 61.3% in the Urgotul
group and 52.1% in the DuoDERM E group (NS); dressings were changed more frequently in the
DuoDERM E group (2.54 ± 0.57 times per week versus 2.31 ± 0.45 in the Urgotul group, p=0.047).
Thirty-three local adverse events were recorded in 27 patients: 10 in the Urgotul group and 23 in the
DuoDERM E group (p=0.039). Nurses reported better acceptability for the Urgotul dressing, based on
pain on removal, maceration and odour (p<0.0001).
l Conclusion: Both dressings showed similar efficacy for the local treatment of venous leg ulcers.
Nevertheless, medical and nursing staff reported better tolerance and acceptability for the
Urgotul dressing.
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