Status:
UNKNOWN
Monochromatic Phototherapy on Diabetic Foot Ulcers
Lead Sponsor:
Biolight AB
Conditions:
Diabetic Foot Ulcers
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Detailed Description
Description of Biolight® Therapy and device The therapy works by applying, for each indication, a specific combination of pulsating monochromatic light to specific areas of the body. The therapy is no...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2012
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00859599
Start Date
August 1 2008
End Date
April 1 2012
Last Update
June 8 2011
Active Locations (7)
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1
Department of Medicine
Ängelholm, Skåne County, Sweden, SE-452 80
2
Frölunda Specialistsjukhus
Gothenburg, Sweden, SE-421 22
3
Regional Hospital, Halmstad
Halmstad, Sweden, SE-301 85
4
Karolinska University Hospital
Huddinge, Sweden, SE-141 86