Monochromatic Phototherapy on Diabetic Foot Ulcers - Full Text View

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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Monochromatic Phototherapy on Diabetic Foot Ulcers. A Twenty Weeks Prospective, Randomised, Double Blind, Multi-centre, Placebo Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Foot Foot Health

U.S. FDA Resources

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:	April 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 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. Other Names: Biolight® Care Device (BCD) Biolight® Wound Care Device (WCD) Monochromatic Light Therapy Monochromatic phototherapy 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.
Placebo Comparator: 2 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. Other Names: Biolight® Care Device (BCD) Biolight® Wound Care Device (WCD) Monochromatic Light Therapy Monochromatic phototherapy 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

Active Comparator: 1

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.

Other Names:

Biolight® Care Device (BCD)
Biolight® Wound Care Device (WCD)
Monochromatic Light Therapy
Monochromatic phototherapy

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.

Placebo Comparator: 2

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.

Other Names:

Biolight® Care Device (BCD)
Biolight® Wound Care Device (WCD)
Monochromatic Light Therapy
Monochromatic phototherapy

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: Pär Olausson Lidö	+46 8 622 52 70	par.olausson@biolight.se

Locations

Sweden
Department of Medicine	Recruiting
Ängelholm, Skåne, Sweden, SE-452 80
Contact: Anders Nilsson, Dr +46 431 817 85 anders.l.nilsson@skane.se
Principal Investigator: Anders Nilsson, Dr
Frölunda Specialistsjukhus	Terminated
Göteborg, Sweden, SE-421 22
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
Karolinska University Hospital	Terminated
Huddinge, Sweden, SE-141 86
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
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
Uddevalla Hospital	Terminated
Uddevalla, Sweden, SE-451 80

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:	Hans Johansson, Manager Clinical Trials And Product Manager Wound, Biolight AB
ClinicalTrials.gov Identifier:	NCT00859599 History of Changes
Other Study ID Numbers:	BL-039, H15:321/2008
Study First Received:	February 27, 2009
Last Updated:	June 7, 2011
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Biolight AB:

Monochromatic Phototherapy
Diabetic Foot Ulcers
Wound healing
Bacterial colonisation

Additional relevant MeSH terms:

Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer

Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on May 19, 2013