The aim of this study is to investigate if eye drop medication (timolol) for high eye pressure (glaucoma) could help to heal diabetic foot ulcers. The main outcomes to be measured will be the time it takes for ulcers to heal and the level of timolol in the blood. This study is being carried out in California, the United States.
The details
Foot ulcers are a common complication of diabetes. Diabetic foot ulcers are very difficult to heal. They can easily become infected and result in severe pain and possibly require amputation. Therefore, it is very important to improve therapies for ulcer healing. Timolol is an eye drop medication used in the treatment of glaucoma. Laboratory and animal result have suggested that by dropping timolol directly onto foot ulcers, it may help them to heal.
The purpose of this study is to investigate how safe and effective timolol is in the healing of diabetic full ulcers. The main outcomes to be measured will be the time it takes for ulcers to heal (assessed over a 12- week period) and the level of timolol in the blood. The level of timolol in the blood is a measure of safety. The lower the level of timolol in the blood, the safer the treatment is.
Who are they looking for?
This study is recruiting 138 patients. Patients must have a foot ulcer below the bony part of the ankle which has been there longer than 30 days but less than 2 years. If it has been there for over 6 months, they must have had a biopsy to out rule cancer. Patients must be willing and able to give consent and comply with all the study requirements.
The ulcer must not be caused by something other than diabetes (e.g. burns or vein disease). The ulcer must not be less than 3cm away from another ulcer and there must not be more than 3 ulcers on the study foot. The ulcer or foot must not have any infection. Patients must not have a HbA1c of more than 12% or have liver enzymes raised to above 2 times the normal limit. Patients must not have been treated with immunosuppressants, radiation, chemotherapy or growth factors in the 60 days before screening or been in the hospital for the treatment of their diabetic foot ulcer in the 30 days before screening. Females must agree to use adequate contraception during the trial.
How will it work
Patients will be randomized to receive either standard of care and timolol treatment or standard of care and hydrogel (a gel that has no active ingredient to promote healing). The time it takes for ulcers to heal within a 12-week period and within a 31-week period will be measured. Levels of timolol in the blood will be measured with a blood test throughout the 31-week period. Patients will be followed for 31 weeks.
