A phase 2 multicentre randomized controlled comparative efficacy and safety study of Tiscover and AS210 in chronic (arterio-)venous ulcers
- Conditions
- been en voet ulcera door (arterio)-veneuze insufficientiechronic lower leg and foot woundshard to heal ulcers10047043
- Registration Number
- NL-OMON40033
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 49
Presence of confirmed venous or arterio-venous ulcer.
Patients age over 18 years
Ulcer duration over 12 weeks and less than 15 years consecutively
<30% ulcer size reduction in 4 weeks prior to inclusion
Ulcer is between 1-40 cm2 in size
Ankle brachial pressure index (ABPI) * 0.6 and * 1.3
Ulcer depth <1 cm
Mobile, at least able to walk with medical walker, and able to return for required treatments and study evaluations
(Legially) capable to give informed consent
Able to understand and comply with requirements of study protocol
Ulcer chronicity < 12 weeks
Severe co-morbidity reducing life expectance to < 1 year
Use of oral corticosteroids and/or cytostatics >20 mg/per day;
Allergy to Gentamycin (which is used in the tissue media), or the used local wound treatments
Severe infection of ulcer, active cellulitis, osteomyelitis
Expected non compliance with compression therapy, protocol treatment or no informed consent
Severe malnutrition
Uncontrolled diabetes mellitus, HbA1c > 12% (108 mmol/mol)
Anaemia Hb <6 mmol/l
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Safety<br /><br>- Assessed by describing the number and type of adverse events; any untoward<br /><br>medical occurrence in a trial participant, even if it does not<br /><br>necessarily have a causal relationship with the treatment, will be reported.<br /><br><br /><br>2. Efficacy; assessed by determining:<br /><br>- Time to heal (in weeks)<br /><br>- Number and percentage of closed wounds, within 26 weeks after application<br /><br>of Tiscover or AS210<br /><br>Complete wound closure is defined as total epithelialization with no wound<br /><br>exudate being present. Digital photographs will record wound closure.<br /><br><br /><br>- Wound size reduction<br /><br>The percentage of reduction in wound area within 26 weeks after<br /><br>application of Tiscover or AS210 in week 12 and week 26. Wound size is measured<br /><br>with Visitrak® wound measurement system (Smith & Nephew) and wound digital<br /><br>photographs. </p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Recurrence<br /><br>- Number and percentage of closed wounds at 3 and 6 months.<br /><br><br /><br>2. Quality of the healed skin<br /><br>- Closed wounds will be visually assessed regarding to scarring.<br /><br><br /><br>3. Quality of life<br /><br>- Quality of life measured at baseline, when closed and at 3 and 6 months<br /><br>follow up.<br /><br>Quality of life will be assessed using:<br /><br>i) SF36; Quality of life score<br /><br>ii) Numeric pain rating scale for experienced pain (VAS scale)<br /><br><br /><br>Take rate of individual Tiscover and AS210 patches.<br /><br>Number and percentage of Tiscover or AS210 patches present on the wound after<br /><br>weekly wound care at weeks 2 - 26</p><br>