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Comparative Study of Combination Treatment of Bionerv E+ Versus Vitamin B Complex in Treatment of Diabetic Polyneuropathy in Type 2 Diabetic Patients and Its Effect on Wound Healing

RecruitingNAAges 18 Years - anyAllBREGO Life Sciences
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In plain words

What the trial is, and whether it could suit you

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+, wh

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Aged 18 years and above 2. Diagnosed with Type 2 Diabetes Mellitus 3. HbA1C of \<8% 4. Symptoms of DSPN attributed by diabetes mellitus using Toronto Clinical Neuropathy Scoring (TCNS) 5. No recent changes of medications for DSPN for the last 3 months 6. Neuropathy Impairment Score (NIS) for lower limbs โ‰ฅ 2 points 7. DFU is classified as Wagner 1 or 2 on the Wagner classification system. 8. Patients with type 1 or type 2 diabetes with a non-healing foot ulcer of at least 4 weeks' duration. 9. If more than one non-healing wound is present, the largest wounds that are classified as a Wagner 1 or 2 will be selected. 10. The index ulcer has to be clinically non-infected. 11. Ankle Brachial Index (ABI) higher than or equal to 0.7. 12. Index foot ulcers that are located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces). 13. Wound area (length X width) measurement between 2 cm2 and 20 cm2. 14. Non-use of drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive, and cytotoxic agents. 15. No smoking, alcohol or drug addiction. 16. Approved, informed, signed consent. Exclusion Criteria: * 1\. Previous consumption of vitamin E and other antioxidants, taking anti-inflammatory agents for the past 3 months. 2\. Presence of other neurological disorders causing neuropathy / myopathy 3. Presence of peripheral vascular disease with ABSI \<0.8 4. Use of anti-oxidants or Pentoxyphylline within the last 3 months 5. Use of ALA or ALA-containing substance within the last 3 months 6. End stage renal disease 7. Liver impairment 8. Psychiatry illness 9. Cancer patients 10. History of lower limb amputations (Ray amputation not excluded) 11. Index ulcer has exposed tendons, ligaments, muscle, or bone. 12. Confirmed presence of osteomyelitis, or if osteomyelitis is suspected.
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What it tests

  • Alpha-Lipoic Acid, Vitamin B1, Vitamin B6, Vitamin B12, Vitamin E
  • Vitamin B1, Vitamin B6, Vitamin B12
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Where

1 site
Hospital Canselor Tuanku Muhriz (HCTM) UKM
Cheras, Malaysia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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