Evaluation of the Efficacy of Multilayer Compression & UrgoStart Plus

Launched by GLOUCESTERSHIRE HOSPITALS NHS FOUNDATION TRUST · Aug 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treating venous leg ulcers, which are wounds that can be difficult to heal and often come back after treatment. Researchers want to see if using a special dressing called UrgoStart Plus, along with compression bandages, can help these ulcers heal better over 12 weeks compared to a standard dressing. The goal is to find out if this new method can improve healing rates for patients with recent ulcers that are not infected and are between 2 and 20 square centimeters in size.

To participate in the trial, you need to be at least 18 years old and willing to attend regular follow-up appointments. You must have a new venous leg ulcer that has lasted less than six weeks and meets certain health criteria. Throughout the study, participants will receive care and support to ensure proper treatment. It’s important to note that those who can't tolerate compression therapy or have certain health issues may not be eligible. This trial aims to provide insights that could help improve the care of patients with challenging leg ulcers.

Gender

ALL

Eligibility criteria

• 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.