The purpose of the trial is to evaluate the effectiveness of the BioFOAM dressing in achieving rapid debridement of chronic wounds typified by leg ulcers. Removal of slough and necrotic tissue from these wounds is essential if the wound is to heal effectively. Sloughy and/or necrotic ulcers of purely venous or mixed arterial/venous aetiology will be considered.
Conditions
Interventions
Product Name: BioFOAM
Product Code: BFD
Pharmaceutical Form: Living tissue equivalent
Sponsors
ZooBiotic Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: People for whom all of the following criteria apply: - 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 that can be identified as the reference ulcer; this ulcer must be at least 5cm away from any other ulcer. - Have an ulcer with an area of >/= 2 square cm and =65 years) yes F.1.3.1 Number of subjects for this age range 86
Exclusion criteria
Exclusion criteria: People who: - Have previously been entered into the intervention phase of 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, which in the opinion of the recruiting health care professional would not be suitable for treatment with larval therapy and/or hydrogel. - Patients on anti-coagulant therapy i.e. Warfarin and Heparin (note that patients on prophylactic low molecular weight Heparin may be included). - People with diabetes mellitus whose blood sugar is not well controlled (HbA1c greater than 10% as measured within the past 12 weeks). - Patients with clinical signs of infection on the day of enrolment. - Patients on antibiotics. - Patients who have deep wounds with exposed bone, tendon or muscle. - People for whom particpation would not be in their best interests, in the opinion of the recruiting health professional.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the clinical effectiveness of BioFOAM dressing with a standard debridement technique (hydrogel dressing) in terms of its effect in time to debridement of leg ulcers. ; Secondary Objective: To investigate and obtain data relating to: safety changes in the clinical presentation of the wound bed wound signs and symptoms changes in the condition of the surrounding skin costs associated with achieving debridement ; Primary end point(s): The primary outcome is the time to debridement of the reference ulcer. The reference ulcer will be defined at the randomisation visit as the largest ulcer containing AT LEAST 25% slough and/or necrotic tissue and must be >/= 2 square cm in area, and at least 5cm from any other ulcer. The endpoint ("debridement") is defined as a clean wound bed that no longer requires a debriding agent. The clinician treating the patient will make an initial review of the wound bed at each visit. At each subsequent visit the wound bed status will be verified by a practising health professional not involved in the study. A blinded assessment will take place once all evidence of the treatment used has been removed from the assessment room. The blinded assessor will record the status of the wound bed and the need to continue with a debriding agent. ;Timepoint(s) of evaluation of this end point: At scheduled visits throughout the trial at intervals of 3-4 days until debridement is noted or 21 days maximum. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No secondary endpoints however the reference ulcer will be monitored for chnages in the clinical presenttaion of the wound bed, wound signs and symptoms, changes in the condition of the surrounding skin and any adverse events or adverse drug reactions at each scheduled visit and at a follow up visit 1-2 weeks after debridement has been recorded or 21 days. ;Timepoint(s) of evaluation of this end point: Ongoing evaluation at scheduled clinic visits up to point of debriement or 21 days whichever comes first. This is followed by a follow up viist 1-2 weeks after the treatment phase. | — |
Countries
United Kingdom
Contacts
Public ContactClinical Trials Information
ZooBiotic Limited
Outcome results
None listed