Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06007703
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-23
First Post:
2023-08-17
Brief Title:
Evaluation of the Efficacy of Multilayer Compression UrgoStart Plus
Sponsor:
Gloucestershire Hospitals NHS Foundation Trust
Organization:
Gloucestershire Hospitals NHS Foundation Trust
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 327680 | OTHER | South West - Cornwall Plymouth Research Ethics Committee | None |