Evaluation of the Efficacy of Multilayer Compression & UrgoStart Plus

NCT06007703 | Completed

• 2 other identifiers: 23/003/GHT327680
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Historically, venous leg ulcers have been very difficult to manage, with associated poor healing rates, and the likelihood of recurrence. Even following correction of underlying venous dysfunction, ulcers can take time to respond to conventional treatment with compression therapy. Recently, the leg ulcer service in Gloucestershire - part of the vascular surgical team - have been using an interactive dressing called UrgoStart Plus under compression therapy in the management of chronic venous leg ulcers and we have experienced some positive outcomes for otherwise recalcitrant ulcers. A previous study published in 2017 by Meaume et al demonstrated a reduction in wound surface area after 8 weeks of treatment with UrgoStart Plus. However, whether or not use of the dressing, in combination with compression bandages, improves 12-week healing rates, remains an unanswered question. The aim of the proposed study is to provide an evaluation of this interactive dressing when used under compression bandages and to compare 12-week healing rates with a similar cohort of patients who have been treated with a simple low adherent dressing under compression. This has been our gold standard up to now and we have been collecting prospective data from patients treated in our unit.

Conditions

Venous Leg Ulcer; Venous Ulcer; Venous Insufficiency of Leg; Leg Ulcer

Keywords

Ulcer; Venous

Outcome Measures

Primary Outcomes (1)

• Time to healing

  Complete ulcer closure (100% re-epithelialisation) after a maximum of 12 weeks treatment period.

  12 weeks

Secondary Outcomes (1)

• Patient health related quality of life

  12 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients recruited for this clinical investigation will be patients treated on an outpatient basis for a venous leg ulcer presenting with an ABPI\>0.85 (venous origin). This is in accordance with local management protocol.

You may qualify if:

• 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"),

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Gloucestershire Hospitals NHS Foundation Trust: lead

Study Sites (1)

Gloucestershire Royal Hospital

Gloucester, Gloucestershire, GL1 3NN, United Kingdom

Location

Related Publications (1)

• Meaume S, Truchetet F, Cambazard F, Lok C, Debure C, Dalac S, Lazareth I, Sigal ML, Sauvadet A, Bohbot S, Dompmartin A; CHALLENGE Study Group. A randomized, controlled, double-blind prospective trial with a Lipido-Colloid Technology-Nano-OligoSaccharide Factor wound dressing in the local management of venous leg ulcers. Wound Repair Regen. 2012 Jul-Aug;20(4):500-11. doi: 10.1111/j.1524-475X.2012.00797.x. Epub 2012 Jun 8.

  PMID: 22681551 BACKGROUND

MeSH Terms

Conditions

Varicose Ulcer; Leg Ulcer; Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Colin E Davies, MSc

  Gloucestershire Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: October 20, 2023
• Primary Completion: September 30, 2024
• Study Completion: March 31, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)