Monochromatic Phototherapy on Diabetic Foot Ulcers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Biolight AB.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Biolight AB
ClinicalTrials.gov Identifier:
NCT00859599
First received: February 27, 2009
Last updated: June 7, 2011
Last verified: June 2011
  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:


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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Diabetic Foot
Ulcer
Foot Ulcer
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 July 22, 2014