AQUACEL® Ag Dressing and Urgotul® Silver Dressing on Healing of Chronic Venous Leg Ulcers

• Wound closure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Clinical evolution of the wound [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  presence of each of the 5 selected clinical signs
• Tolerance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  occurrence of local adverse events

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.

• Device: AQUACEL® Ag
  AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks.
• Device: Urgotul® Silver
  Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks.

• Active Comparator: Urgotul® Silver
  Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks.
  Intervention: Device: Urgotul® Silver
• Active Comparator: AQUACEL® Ag
  AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks.
  Intervention: Device: AQUACEL® Ag

Inclusion Criteria:

• Subjects over 18 years, willing and able to provide written informed consent.
• Subjects who have an ankle to brachial pressure index (ABPI) of 0.8 or greater.
• Subjects who have a venous leg ulcer (i.e. CEAP classification of C6), with duration less than 24 months and size ranging between 5 cm2-40 cm2 .
• Subjects' leg ulcers will meet at least 3 of the 5 following clinical signs: pain between 2 dressing changes, perilesional skin erythema, oedema, foul odour, and heavy exudation.
• Subjects agree to wear compression therapy daily in combination with the trial dressing.

Exclusion Criteria:

• Subjects with a history of skin sensitivity to any of the components of the study product.
• Subjects who have had current local or systemic antibiotics in the week prior to inclusion.
• Subjects whose leg ulcers are clinically infected or erysipelas, malignant, or who have had recent deep venous thrombosis or venous surgery within the last 3 months.
• Subjects who have a progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents or high dose corticosteroids.
• Subjects who have participated in a clinical study within the past 3 months.
• Subjects who are pregnant or breastfeeding (in accordance with the Urgotul® Silver package insert).