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

ISRCTN ISRCTN22579989
DOI https://doi.org/10.1186/ISRCTN22579989
Secondary identifying numbers Dnr: 2014/795
Submission date
12/12/2017
Registration date
18/12/2017
Last edited
18/12/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Mrs Alejandra Vásquez
Scientific

Lund University
Section of Medical Microbiology
Sölvegatan 23
Lund
SE-223 63
Sweden

ORCiD logoORCID ID 0000-0002-1777-9554
Phone +46 462221694
Email alejandra.vasquez@med.lu.se

Study information

Study designProof-of -concept multicentre study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleProof of concept study to investigate if a novel formulation with a Lactic Acid Bacterial microbiome has an effect on Venous Leg Ulcers
Study objectivesCan a novel microbiome composed of lactic acid bacteria have an effect on chronic leg ulcers?
Ethics approval(s)Ethical Committee Lund, Sweden, 09/12/2014, ref: Ethical application Dnr: 2014/795
Health condition(s) or problem(s) studiedChronic leg ulcers
InterventionParticipants 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 typeBiological/Vaccine
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureProgression 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 measures1. 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 study start date01/09/2014
Completion date01/09/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants16 patients
Key inclusion criteria1. 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
Key exclusion criteriaPatients treated with systemic antibiotics or who had cognitive or linguistic impairment are excluded.
Date of first enrolment15/01/2015
Date of final enrolment01/08/2015

Locations

Countries of recruitment

  • Denmark
  • Sweden

Study participating centres

Blekinge Wound Healing Centre
Blekinge Hospital
Karlshamn
SE-374 80
Sweden
Sønderborg Wound Healing Centre
Sønderjylland Hospital
Sønderborg
DK-6400
Denmark
Infection Clinic Danderyd Hospital
Danderyd
SE-18288
Sweden
Bensårcentrum Skaraborgs Hospital
Skövde
SE-54185
Sweden

Sponsor information

Lund University
University/education

Medicinska Fakulteten
Lunds universitet, Box 117
Lund
SE-221 00
Sweden

Phone +464 6222 00 00
Email info@med.lu.se
ROR logo "ROR" https://ror.org/012a77v79

Funders

Funder type

Charity

Ekhaga Foundation

No information available

The Capio Research Foundation

No information available

The Swedish Research Council (VR)

No information available

STRAMA

No information available

Results and Publications

Intention to publish date01/12/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planThe 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 planThe current data sharing plans for the current study are unknown and will be made available at a later date.