Patient with venous ulcers or mixed aetiology ulcers containig necrotic tissue MedDRA version: 9.1 Level: LLT Classification code 10066677 Term: Chronic leg ulcer
Conditions
Interventions
Pharmaceutical Form: Impregnated pad
INN or Proposed INN: LarvE BIOFoam dressing
Concentration unit: cm2 square centimeter
Concentration type: equal
Concentration number: 10-
Sponsors
ASL 2 SAVONESE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are aged 18 years or above and have a sloughy and/or necrotic leg ulcer (slough and/or necrotic tissue estimated to cover a minimum of 25% of the wound) of purely venous or mixed arterial/venous aetiology. Patients have an ulcer with an area of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: People who: Have previously been entered into the trial Are women of child bearing potential Are pregnant or lactating women Are allergic to hydrogel dressings or any of their components Have grossly oedematous legs Patients on anti-coagulants People with diabetes mellitus whose blood sugar is not well controlled (HbA1c greater than 10%).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the clinical effectiveness of a larval therapy dressing with a standard debridement technique (hydrogel) in terms of its effect on time to debridement of leg ulcers.;Secondary Objective: None;Primary end point(s): The time to debridement of the ulcers | — |
Countries
Italy
Outcome results
None listed