Monochromatic Phototherapy on Diabetic Foot Ulcers - Full Text View

Sponsored by:	Biolight AB
Information provided by:	Biolight AB
ClinicalTrials.gov Identifier:	NCT00859599

Purpose

The purpose of this study is to evaluate the efficacy and safety of monochromatic phototherapy (Biolight®) on foot ulcers in diabetic patients, in comparison of placebo phototherapy as a complementary to standard diabetic foot ulcer therapy.

The study initiated with a four week long Run In Period to eliminate spontaneous healing ulcer to be included. Treatment with monochromatic phototherapy (Biolight® or placebo) will be given locally, additional to standard care, three times weekly during the first four weeks and twice weekly the following sixteen weeks or until the ulcer is completely healed, according to a pre-determined treatment plan. The area of the ulcer will be measured once weekly for 20 weeks or until the ulcer is completely healed.

Condition	Intervention	Phase
Diabetic Foot Ulcers	Device: Monochromatic phototherapy, Biolight® Device: Monochromatic phototherapy	Phase III

MedlinePlus related topics: Diabetic Foot Foot Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Monochromatic Phototherapy on Diabetic Foot Ulcers. A Twenty Weeks Prospective, Randomised, Double Blind, Multi-Centre, Placebo Controlled Study

Further study details as provided by Biolight AB:

Primary Outcome Measures:

Number of subjects who completely healed and time to 100% wound reduction. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time to 50% wound reduction, Subjects with increased ulcer and/or wound reduction less than 20%, Wound status, Elimination of gram-positive and anaerobic bacteria from the wound, Hospitalization caused of foot ulcer, Presence and level of amputation [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	107
Study Start Date:	August 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator At the study start, the patient will be given a subject number according to a fixed randomisation list. The investigator/study nurse will be instructed to log in at the Biolight® website to get the patient-number and treatment code, with the information which treatment model (i.e. marked A & B, E F, X & Y) the randomised patient shall receive. Up to 44 monochromatic Phototherapy treatment sessions (Biolight® or placebo) will be given, additional to standard care treatment. The treatment session schedule compromise of three times weekly during the first four weeks and twice weekly during the following weeks or until the ulcer is completely healed.	Device: Monochromatic phototherapy, Biolight® Monochromatic phototherapy (Biolight®) will be given locally, additional to standard care, three times weekly during the first four weeks and twice weekly the following sixteen weeks or until the ulcer is completely healed, according to a pre-determined treatment plan. Device: Monochromatic phototherapy Monochromatic phototherapy (Biolight®) will be given locally, additional to standard care, three times weekly during the first four weeks and twice weekly the following sixteen weeks or until the ulcer is completely healed, according to a pre-determined treatment plan.
2: Placebo Comparator At the study start, the patient will be given a subject number according to a fixed randomisation list. The investigator/study nurse will be instructed to log in at the Biolight® website to get the patient-number and treatment code, with the information which treatment model (i.e. marked A & B, E F, X & Y) the randomised patient shall receive. Up to 44 monochromatic Phototherapy treatment sessions (Biolight® or placebo) will be given, additional to standard care treatment. The treatment session schedule compromise of three times weekly during the first four weeks and twice weekly during the following weeks or until the ulcer is completely healed.	Device: Monochromatic phototherapy, Biolight® Monochromatic phototherapy (Biolight®) will be given locally, additional to standard care, three times weekly during the first four weeks and twice weekly the following sixteen weeks or until the ulcer is completely healed, according to a pre-determined treatment plan. Device: Monochromatic phototherapy Monochromatic phototherapy (Biolight®) will be given locally, additional to standard care, three times weekly during the first four weeks and twice weekly the following sixteen weeks or until the ulcer is completely healed, according to a pre-determined treatment plan.

Arms

Assigned Interventions

1: Active Comparator

At the study start, the patient will be given a subject number according to a fixed randomisation list. The investigator/study nurse will be instructed to log in at the Biolight® website to get the patient-number and treatment code, with the information which treatment model (i.e. marked A & B, E

F, X & Y) the randomised patient shall receive. Up to 44 monochromatic Phototherapy treatment sessions (Biolight® or placebo) will be given, additional to standard care treatment. The treatment session schedule compromise of three times weekly during the first four weeks and twice weekly during the following weeks or until the ulcer is completely healed.

Device: Monochromatic phototherapy, Biolight®

Monochromatic phototherapy (Biolight®) will be given locally, additional to standard care, three times weekly during the first four weeks and twice weekly the following sixteen weeks or until the ulcer is completely healed, according to a pre-determined treatment plan.

Device: Monochromatic phototherapy

Monochromatic phototherapy (Biolight®) will be given locally, additional to standard care, three times weekly during the first four weeks and twice weekly the following sixteen weeks or until the ulcer is completely healed, according to a pre-determined treatment plan.

2: Placebo Comparator

At the study start, the patient will be given a subject number according to a fixed randomisation list. The investigator/study nurse will be instructed to log in at the Biolight® website to get the patient-number and treatment code, with the information which treatment model (i.e. marked A & B, E

F, X & Y) the randomised patient shall receive. Up to 44 monochromatic Phototherapy treatment sessions (Biolight® or placebo) will be given, additional to standard care treatment. The treatment session schedule compromise of three times weekly during the first four weeks and twice weekly during the following weeks or until the ulcer is completely healed.

Device: Monochromatic phototherapy, Biolight®

Monochromatic phototherapy (Biolight®) will be given locally, additional to standard care, three times weekly during the first four weeks and twice weekly the following sixteen weeks or until the ulcer is completely healed, according to a pre-determined treatment plan.

Device: Monochromatic phototherapy

Monochromatic phototherapy (Biolight®) will be given locally, additional to standard care, three times weekly during the first four weeks and twice weekly the following sixteen weeks or until the ulcer is completely healed, according to a pre-determined treatment plan.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Wagner grade 1-2 (superficial or deep ulcer)
Size of ulcer 1 -25 cm2
Localisation of the ulcer below the ankle
Systolic ankle blood pressure >80 mmHg or
Systolic toe blood pressure >45 mmHg equal to and higher than or only
Type 1 or II diabetes - Previously known diabetes according to WHO criteria
HbA1c <12
> 18 year
Willing and able to fulfil the study requirements
Written informed consent

Exclusion Criteria:

Earlier participation in this study
Life-threatening malignancy
Systemic, oral use of corticosteroid preparations (> 7.5 mg Prednisolon)
Immunosuppressive treatment such as cytostatic drugs and TNF-antagonists
Kidney insufficiency (Creatinine >250 micromol/l)
Clinical signs of infections
Antibiotic treatment the last two weeks
Suspected venous genesis
More than two ulcers per foot
Wagner grade 3-5
Location of ulcers making treatment or evaluation not feasible
Photosensitivity or other sensitivity to electromagnetic radiation
Pregnancy or breastfeeding
Participation in any clinical study the last three month

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859599

Contacts

Contact: Hans Johansson	+46 31 336 91 02	hans.johansson@biolight.se
Contact: Claes Holmberg	+46 31 336 91 01	claes.holmberg@biolight.se

Locations

Sweden
Malmö University Hospital	Recruiting
Malmö, Sweden, SE-205 02
Contact: Jan Apelqvist, Ass prof +46 40 33 23 84 jan.apelqvist@skane.se
Principal Investigator: Jan Apelqvist, Ass Prof
Karolinska University Hospital	Recruiting
Huddinge, Sweden, SE-141 86
Contact: Kurt Gerok Andersson, Ass prof +46 8 585 80 000 kurt.gerok-andersson@karolinska.se
Contact: Kerstin Brismar, Prof +46 8 517 72 845 kerstin.brismar@ki.se
Principal Investigator: Kurt Gerok Andersson, Ass prof
Sub-Investigator: Börje Åkerlund, Dr
Sub-Investigator: Kerstin Brismar, Prof
Lund University Hospital	Recruiting
Lund, Sweden, SE-221 85
Contact: Magnus Löndahl, Dr +46 46 17 22 35 Magnus.Londahl@skane.se
Contact: Per Katzman, Ass prof +46 46 17 22 35 Per.Katzman@skane.se
Principal Investigator: Magnus Löndahl, Dr
Sub-Investigator: Per Katzman, Ass prof
Uddevalla Hospital	Recruiting
Uddevalla, Sweden, SE-451 80
Contact: Vassili Merkoulov, Dr +46 522 933 44 vassili.merkoulov@vgregion.se
Principal Investigator: Vassili Merkoulov, Dr
Regional Hospital, Halmstad	Recruiting
Halmstad, Sweden, SE-301 85
Contact: Stefan Sjöberg, Ass prof +46 35 17 43 96 Stefan.sjoberg@lthalland.se
Principal Investigator: Stefan Sjöberg, Ass prof
Frölunda Specialistsjukhus	Not yet recruiting
Göteborg, Sweden, SE-421 22
Contact: Tomas Linden, Dr +46 31 342 50 00 tomas.linden@vgregion.se
Principal Investigator: Tomas Linden, Dr

Sponsors and Collaborators

Biolight AB

Investigators

Principal Investigator:

Jan Apelqvist, M.D., Ph.D.

Malmö University Hospital, Department of Endocrinology

More Information

No publications provided

Responsible Party:	Biolight AB ( Hans Johansson, Manager Clinical Trials And Product Manager Wound )
Study ID Numbers:	BL-039, H15:321/2008
Study First Received:	February 27, 2009
Last Updated:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00859599 History of Changes
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Biolight AB:

Monochromatic Phototherapy
Diabetic Foot Ulcers
Wound healing
Bacterial colonisation

Study placed in the following topic categories:

Foot Ulcer
Skin Diseases
Diabetic Neuropathies
Ulcer
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases

Foot Diseases
Diabetic Angiopathies
Endocrinopathy
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer

Additional relevant MeSH terms:

Foot Ulcer
Diabetic Neuropathies
Skin Diseases
Ulcer
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Foot Diseases

Diabetic Angiopathies
Pathologic Processes
Cardiovascular Diseases
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer

ClinicalTrials.gov processed this record on May 06, 2009