Evaluation of the Efficacy of Multilayer Compression & UrgoStart Plus

Leg ulcers are notoriously difficult to treat with poor outcomes often reported. The majority of these ulcers are caused by a deficient venous return from the to lower leg and the mainstay in treatment is compression therapy and further venous treatments such as foam sclerotherapy. However, some ulcers still take many months to heal causing great suffering and reduced quality of life and great expense to the NHS.

More knowledge has been gained concerning the impact of protease (enzyme) activity in venous leg ulcers and high numbers of these could contribute to the non-healing state. UrgoStart Plus is an interactive dressing which has a protease modulating effect and has been shown to reduce proteases and improve healing. The CHALLENGE trial published by Meaume et al (2012) showed significant reductions in wound surface area following eight weeks of treatment with UrgoStart for venous leg ulcers and diabetic foot ulcer. However, there is no published data as yet evaluating impact on healing of venous ulcers at 12 weeks.

The present study aim is to evaluate the 12-week healing rates in patients with venous leg ulcers treated in a proven compression system using UrgoStart Plus as the wound contact layer. This can be compared with 12-week healing for a similar cohort of patients treated with the same compression system and a simple low adherent non-interactive dressing.

Inclusion criteria

• Related to the patient:
• Patient over 18 years old who has provided his/her written informed consent,
• Patient who is able and willing to commit to regular follow up with the investigating team for the purpose of the study, and in line with established service protocols for routine patient follow up until ulcer healed,
• Patient who agrees to adhere to the study protocol with respect to the type of multilayer compression system and primary wound dressing,

Related to the venous leg ulcer:

• Ulcer between 2 and 20 cm² in surface,
• Ulcer duration less than six weeks ("new ulcer"),
• Venous leg ulcer - Ankle Brachial Pressure Index > 0.85 at baseline, done in the previous three months and if not, at the inclusion of the patient),

Exclusion criteria

Related to the patient:

• Patient participating in another clinical trial,
• Patient with known hypersensitivity to one of the components of the tested compression system Urgo KTwo Lite Latex free or the UrgoStart dressings,
• Patient who is unable to tolerate compression therapy,
• Patient presenting a neoplastic lesion treated by radiotherapy or chemotherapy or patients treated with immunosuppressive drugs or high-dose corticosteroids,
• Patient with a history of deep or superficial vein thrombosis in the 3 months prior to inclusion,
• Patient confined to bed.

Related to the leg ulcer:

• Ulcer with ABPI<0.85,
• Ulcer which is clinically infected,
• Ulcer surface area partially or totally covered by black necrosis plaque,
• Malignant ulcer,
• Ulcer less than 3 cm, from any edge, to another wound located on the same limb.