Monochromatic Phototherapy on Diabetic Foot Ulcers
2 other identifiers
interventional
107
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2008
Typical duration for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 27, 2009
CompletedFirst Posted
Study publicly available on registry
March 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedJune 8, 2011
June 1, 2011
3.3 years
February 27, 2009
June 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects who completely healed and time to 100% wound reduction.
24 weeks
Secondary Outcomes (1)
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
24 weeks
Study Arms (2)
1
ACTIVE COMPARATORAt 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.
2
PLACEBO COMPARATORAt 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biolight ABlead
Study Sites (7)
Department of Medicine
Ängelholm, Skåne County, SE-452 80, Sweden
Frölunda Specialistsjukhus
Gothenburg, SE-421 22, Sweden
Regional Hospital, Halmstad
Halmstad, SE-301 85, Sweden
Karolinska University Hospital
Huddinge, SE-141 86, Sweden
Lund University Hospital
Lund, SE-221 85, Sweden
Malmö University Hospital
Malmo, SE-205 02, Sweden
Uddevalla Hospital
Uddevalla, SE-451 80, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Apelqvist, M.D., Ph.D.
Malmö University Hospital, Department of Endocrinology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 27, 2009
First Posted
March 11, 2009
Study Start
August 1, 2008
Primary Completion
December 1, 2011
Study Completion
April 1, 2012
Last Updated
June 8, 2011
Record last verified: 2011-06