Venous Leg UlcerNCT06007703
Evaluation of the Efficacy of Multilayer Compression & UrgoStart Plus
An observational study of Venous Leg Ulcer and Venous Ulcer, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer, Venous Ulcer, Venous Insufficiency of Leg
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Oct 2023to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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),
Who cannot join
- 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,
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Gloucestershire Royal Hospital
Gloucester, Gloucestershire, GL1 3NN
About this study
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
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.
Read the 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.
- Conditions
- Venous Leg Ulcer, Venous Ulcer, Venous Insufficiency of Leg, Leg Ulcer
- Keywords
- Ulcer, Venous
- Medical subject headings
- Varicose Ulcer, Leg Ulcer, Ulcer
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to healing
Complete ulcer closure (100% re-epithelialisation) after a maximum of 12 weeks treatment period.
Measured: 12 weeks
Secondary outcomes (1)
Patient health related quality of life
Patient Quality of Life through a specific Wound Quality of Life Questionnaire testing 17 aspects of the leg ulcer and how it impacts on the participant with scores from 0-4 for each statement. The higher the score, the worse the impact.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start20 Oct 2023
- Primary completion30 Sep 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Colin E Davies, MSc, Principal investigator, Gloucestershire Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007703
- Sponsor's protocol ID
- 23/003/GHT
- Other IDs
- 327680
- Status last verified
- Sep 2025
- First submitted
- 17 Aug 2023
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22681551
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06007703
- Acronym / sponsor ID
- 23/003/GHT
- Conditions
- Venous Leg Ulcer, Venous Ulcer, Venous Insufficiency of Leg, Leg Ulcer
- Keywords
- Ulcer, Venous
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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,
- Ulcer between 2 and 20 cm² in surface,
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to healing
Time frame: 12 weeks
Complete ulcer closure (100% re-epithelialisation) after a maximum of 12 weeks treatment period.
1 secondary outcome
Patient health related quality of life
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Background: PubMed 22681551Meaume 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin E Davies, MSc principal investigator
Gloucestershire Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Leg Ulcer and Venous Ulcer, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to healing (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06007703, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.