Monochromatic Phototherapy on Diabetic Foot Ulcers
Sweden107 participantsStarted 2008-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of subjects who completely healed and time to 100% wound reduction.