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Evaluation of the Efficacy of Multilayer Compression & UrgoStart Plus

NCT06007703 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-10-03

No results posted yet for this study

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

Sponsors & Collaborators

  • Gloucestershire Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Colin E Davies, MSc · Gloucestershire Hospitals NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-20
Primary Completion
2024-09-30
Completion
2025-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06007703 on ClinicalTrials.gov