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New dressing combo shows promise for stubborn leg ulcers

NCT ID NCT06007703

Symptom relief Sponsor: Gloucestershire Hospitals NHS Foundation Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether a special interactive dressing (UrgoStart Plus) used with compression bandages can help heal venous leg ulcers faster than standard dressings. Sixty adults with chronic leg ulcers were treated for up to 12 weeks. The goal was to see if the new dressing leads to complete healing and improves quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
UrgoStart Plus interactive dressing and Urgo KTwo multilayer compression bandages
What this could lead to
If successful, this combination could offer a more effective way to heal stubborn leg ulcers faster and improve patients' quality of life.
What could go wrong
This is a small, completed study with only 60 participants, so results may not apply to everyone. The dressing may not significantly improve healing compared to standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

60 people

The number who actually took part.

Started

Oct 2023

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic venous insufficiency Leg Ulcer ulcer disease ulcer of lower limbs Varicose Ulcer venous insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Leg ulcer Venous insufficiency of leg Venous leg ulcer Venous ulcer

Contacts and locations

Locations

  • Gloucestershire Royal Hospital

    Gloucester, Gloucestershire, GL1 3NN, United Kingdom

More trials for these conditions

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