Investigation of a novel formulation with a Lactic Acid Bacterial microbiome on chronic ulcers
Completed
- Conditions
- Chronic leg ulcersCirculatory System
- Registration Number
- ISRCTN22579989
- Lead Sponsor
- und University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
1. Patients >18 years old
2. Diagnosed venous leg ulcers (ankle brachial pressure index (ABPI) >0.8 and clinical signs of venous insufficiency
3. Informed consent
Exclusion Criteria
Patients treated with systemic antibiotics or who had cognitive or linguistic impairment are excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression of healing of wounds was measured following reduction of wound surface area using a digital planimeter (Visitrak, manufactured in the UK for Smith & Nephew Medical Limited, Hull) at inclusion and at the end of the study period.
- Secondary Outcome Measures
Name Time Method 1. Total bacterial load variation in wound samples was measured by calculating viable bacterial counts from isolates aerobically grown on blood agar at week 0 (before treatment), week 3 (middle point) and week 6 (after treatment)<br>2. Bacterial identification was investigated by using two methods, identification using protein patterns in Maldi-Tof and DNA sequencing of the 16S rRNA gene at week 0 (before treatment), week 3 (middle point) and week 6 (after treatment)<br>3. Rise in blood glucose was measured using blood samples at inclusion and at the end of the study period