Condition category
Circulatory System
Date applied
12/12/2017
Date assigned
18/12/2017
Last edited
18/12/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chronic wounds cause significant suffering and cost healthcare systems throughout the world billions every year. Current treatments such as antimicrobials vary in their effectiveness and traditional antibiotics have become less practical with increasing antibiotic resistance. Reports on the type of bacteria causing chronic wounds vary, but it is recognized that a main cause of non-healing in chronic wounds is the presence of many different bacteria. A broad-spectrum, ecological, and easy-to-use treatment is therefore essential for the future of wound management. The participants of this study will test a new treatment composed of a new mixture of friendly bacteria and honey, to investigate if this treatment has any effect on the healing progress of wounds in patients suffering from these during many years and also to delineate if the treatment has any adverse effects. The aim of this study is to see if this new treatment may have a positive effect on wounds by healing them in a fester manner and therefore such a treatment may be a good choice for future wound management being more ecological and with a broad-spectrum ability.

Who can participate?
Adults aged 18 and older who have a venous leg ulcer.

What does the study involve?
Participants have their wound assessed and classified as complex or simple. Participants then receive a formulation of Lactic Acid Bacteria in a matrix of sterilised honey place on the wound. The wound is covered with two dressings: A hydro-fibre dressing applied over the formulation and an outer dressing to keep the formulation on place. The formation is applied twice a week for six weeks. Participants provide blood samples to measure blood glucose before the formulation is applied and 30 minutes after at the beginning and the end of the study.

What are the possible benefits and risks of participating?
A benefit may be that the treatment may heal the wounds faster than conventional treatments. A direct risk may be a rise of blood glucose level cause by the application of the honey containing formulation.

Where is the study run from?
1. Blekinge Wound Healing Centre (Sweden)
2. Sønderborg Wound Healing Centre (Denmark)
3. Infection Clinic Danderyd Hospital (Sweden)
4. Bensårcentrum Skaraborgs Hospital (Sweden)

When is the study starting and how long is it expected to run for?
September 2014 to September 2015

Who is funding the study?
1. Ekhaga Foundation (Sweden)
2. The Capio Research Foundation (Sweden)
3. The Swedish Research Council (VR) (Sweden)
4. STRAMA (Sweden)

Who is the main contact?
Mrs Alejandra Vásquez
alejandra.vasquez@med.lu.se

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Alejandra Vásquez

ORCID ID

http://orcid.org/0000-0002-1777-9554

Contact details

Lund University
Section of Medical Microbiology
Sölvegatan 23
Lund
SE-223 63
Sweden
+46 462221694
alejandra.vasquez@med.lu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Dnr: 2014/795

Study information

Scientific title

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

Acronym

Study hypothesis

Can a novel microbiome composed of lactic acid bacteria have an effect on chronic leg ulcers?

Ethics approval

Ethical Committee Lund, Sweden, 09/12/2014, ref: Ethical application Dnr: 2014/795

Study design

Proof-of -concept multicentre study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic leg ulcers

Intervention

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 wound duration of minimum 6 weeks.

Physicians assess the participants and the wounds prior to the start of the study to confirm diagnosis and suitability for inclusion. The wounds are classified as complex or simple.

The interventions comprised of applying a formulation (consisted of Lactic Acid Bacteria in a matrix of sterilized honey) onto the wounds. The wounds were then covered with two dressings; 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 week during the duration of the study, which is six weeks. In addition, blood glucose samples are taken before the application of the formulation and 30 minutes after application of the formulation. Blood glucose is investigated at inclusion and at the end of the study.

A registered nurse fills in the protocols at three times: at week 0 (before treatment), week 3 (middle point) and week 6 (after treatment). The protocol included information about haemoglobin, smoking habits, overall morbidity, and aspects of the ulcer including wound duration, pain, ulcer size, percentage of fibrinous tissue and granulation, exudation and odour.

All patients continued with their regular compression bandage during the duration of the study.

A registered nurse measured wounds metrically and photos were taken of all wounds prior to the study and at completion of the study at week 6.

Intervention type

Biological/Vaccine

Phase

Drug names

Primary outcome measures

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

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

Overall trial start date

01/09/2014

Overall trial end date

01/09/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

16 patients

Participant exclusion criteria

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

Recruitment start date

15/01/2015

Recruitment end date

01/08/2015

Locations

Countries of recruitment

Denmark, Sweden

Trial participating centre

Blekinge Wound Healing Centre
Blekinge Hospital
Karlshamn
SE-374 80
Sweden

Trial participating centre

Sønderborg Wound Healing Centre
Sønderjylland Hospital
Sønderborg
DK-6400
Denmark

Trial participating centre

Infection Clinic Danderyd Hospital
Danderyd
SE-18288
Sweden

Trial participating centre

Bensårcentrum Skaraborgs Hospital
Skövde
SE-54185
Sweden

Sponsor information

Organisation

Lund University

Sponsor details

Medicinska Fakulteten
Lunds universitet
Box 117
Lund
SE-221 00
Sweden
+464 6222 00 00
info@med.lu.se

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Ekhaga Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Capio Research Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Swedish Research Council (VR)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

STRAMA

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The proof of concept study will be described in a research article. We intend to publish the results as soon as possible, as the study is already performed and completed.

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/12/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes