The Purpose of This Study is to Assess Clinical Efficacy and Safety of Berovenal® Intended to Promote Treatment and to Expedite Chronic Diabetic Foot Ulcer Healing

This study is for men and women between the ages of 18 and 85 who have been diagnosed with either type 1 or type 2 diabetes for at least a year. You would need to have a specific kind of diabetic foot ulcer that is not severely infected, is a certain size (between 1 and 25 square centimetres), and has been present for at least two weeks. Your blood sugar control, measured by a test called HbA1c, should also be within a certain range.

There are also some reasons why you might not be able to join. For example, if you're allergic to hydrogel dressings, or if your ulcer has already started healing significantly on its own recently. They also can't include you if you have certain other conditions affecting your foot, like a severe circulation problem or specific bone infections, or if you're currently using certain other wound treatments or strong medications like chemotherapy. The aim is to make sure the study focuses clearly on the new gel's effect and doesn't get complicated by other health issues or treatments.

If you join this study, you would use either the Berovenal® gel or the comparison gel on your foot ulcer every day for up to 8 weeks, or until your ulcer closes completely, whichever comes first. You’d need to visit the clinic every two weeks for check-ups and to have your ulcer looked at. During these visits, the medical team will assess how your ulcer is healing and check for any changes. You would also be asked to keep a simple diary at home, noting down any symptoms you experience and how often you apply the gel. The maximum total duration you would be actively involved in applying the gel and attending bi-weekly visits would be around 8 weeks.