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.

l Objective: To evaluate the acceptability, tolerance and efficacy of Urgotul wound dressing in the
management of epidermolysis bullosa (EB) skin lesions.
l Method: This was an open-label uncontrolled clinical trial involving 20 patients (11 adults and nine
children) with EB simplex or dystrophic EB. Patients were selected from the register of EB patients at
the investigating centre and included if they presented with at least one skin lesion requiring
management with a non-adherent wound dressing. Lesions were treated with the study dressing for a
maximum of four weeks. All dressing changes, wound parameters, pain and effect on quality of life were
recorded.
l Results: All patients completed the trial. Nineteen out of 20 wounds healed within 8.7 ± 8.5 days.
Overall, 11 patients (55%) considered that their quality of life had improved following use of the dressing,
which was also reported to be pain free and ‘very easy’ or ‘easy’ to remove at most dressing changes.
Nineteen out of 20 patients stated that they would use the study dressing to manage their lesions
in future.
l Conclusion: This study confirmed the very good acceptability and efficacy of Urgotul in the
treatment of skin lesions in patients with EB.