Diabetic symmetrical polyneuropathy (DSPN) is a common complication of diabetes that affects the nerves, especially in the legs and feet. It can cause pain, numbness, tingling, weakness, and loss of sensation. These problems can affect daily activities and quality of life. Loss of sensation can also increase the risk of foot wounds and problems with wound healing.
This study is comparing two treatments in people with type 2 diabetes and DSPN. The main purpose is to find out whether a combination of alpha-lipoic acid, vitamins B1, B6, B12, and vitamin E is providing greater improvement in neuropathy symptoms than vitamins B1, B6, and B12 alone. The study is also examining changes in wound healing.
About 100 participants are taking part at Hospital Canselor Tuanku Muhriz (HCTM). Participants are being randomly assigned to one of two treatment groups. One group is receiving Bionerv E+, which contains alpha-lipoic acid, vitamins B1, B6, B12, and vitamin E. The other group is receiving a vitamin B-complex containing vitamins B1, B6, and B12. Both treatments are being taken daily for 12 weeks in addition to standard treatment for DSPN.
Researchers are assessing participants before and after treatment. These assessments are examining nerve problems in the lower limbs, pain, quality of life, and blood markers related to inflammation. For participants with diabetic foot ulcers, researchers are also assessing changes in the wounds.