Status:
COMPLETED
Evaluation of the Efficacy of Multilayer Compression & UrgoStart Plus
Lead Sponsor:
Gloucestershire Hospitals NHS Foundation Trust
Conditions:
Venous Leg Ulcer
Venous Ulcer
Eligibility:
All Genders
18+ years
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, ul...
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 treatmen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 20 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06007703
Start Date
October 20 2023
End Date
March 31 2025
Last Update
October 3 2025
Active Locations (1)
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1
Gloucestershire Royal Hospital
Gloucester, Gloucestershire, United Kingdom, GL1 3NN