Evaluation of the Efficacy of Multilayer Compression & UrgoStart Plus

Evaluation of the Safety and Effectiveness of the Global Treatment Including Multilayer Compression Therapy (Urgo KTwo®) in Addition to an Interactive Dressing (UrgoStart® Plus) in the Management of Venous Leg Ulcers

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Leg Ulcer; Venous Leg Ulcer; Venous Insufficiency of Leg; Venous Ulcer

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Colin E Davies, MSc; Phone Number: 030042233480; Email: colin.davies1@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to healing	Complete ulcer closure (100% re-epithelialisation) after a maximum of 12 weeks treatment period.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient health related quality of life	Patient Quality of Life through a specific WoundQuol Questionnaire	12 weeks

Collaborators and Investigators

• Sponsor: Gloucestershire Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Colin E Davies, MSc, Gloucestershire Hospitals NHS Foundation Trust

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 2, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Ulcer; Venous
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer; Venous Insufficiency
• Other Study ID Numbers: 23/006/GHT; 327680 (Other Identifier: South West - Cornwall & Plymouth Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No