Investigation of a novel formulation with a Lactic Acid Bacterial microbiome on chronic ulcers

Proof of concept study to investigate if a novel formulation with a Lactic Acid Bacterial microbiome has an effect on Venous Leg Ulcers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN22579989

Enrollment

Registered

2017-12-18

Start date

2015-01-15

Completion date

Unknown

Last updated

2018-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic leg ulcers Circulatory System Chronic leg ulcers

Interventions

Participants included in the study are older than 18 years old, with diagnosed venous leg ulcers (ankle brachial pressure index (ABPI), more than 0.8, and clinical signs of venous insufficiency, with

a hydro-fibre dressing (Aquacel®, Convatec, Sweden) applied over the formulation, and an outer dressing (Eclypse®, Advancis, UK), to keep the formulation on place. The formulation is applied twice a w

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Patients treated with systemic antibiotics or who had cognitive or linguistic impairment are excluded.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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) 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) 3. Rise in blood glucose was measured using blood samples at inclusion and at the end of the study period	—

Measure

Time frame

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) 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) 3. Rise in blood glucose was measured using blood samples at inclusion and at the end of the study period

—

Countries

Denmark, Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026