An interventional study of Alpha-Lipoic Acid, Vitamin B1, Vitamin B6, Vitamin B12, Vitamin E and Vitamin B1, Vitamin B6, Vitamin B12 in Diabetic Foot Ulcer (DFU) and Diabetic Symmetrical Polyneuropathy, sponsored by BREGO Life Sciences. Recruiting at 1 site in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by BREGO Life Sciences · Not applicable, Interventional, and Treatment
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.
Diabetic symmetrical polyneuropathy (DSPN) is a common chronic complication of diabetes mellitus. It is characterized by symmetrical, length-dependent damage to peripheral nerves and may cause pain, burning sensations, numbness, tingling, weakness, and loss of protective sensation. Loss of protective sensation may increase the risk of foot injury, ulceration, infection, and other diabetic foot complications.
Alpha-lipoic acid (ALA) and vitamin E have antioxidant properties and have been studied for their potential roles in reducing oxidative stress associated with diabetic neuropathy. Vitamins B1, B6, and B12 have roles in normal nerve function and have also been used in the management of neuropathy. This study is therefore evaluating whether adding ALA and vitamin E to a vitamin B combination provides additional benefits for participants with DSPN.
This is a single-centre open label study being conducted at the Hospital Canselor Tuanku Muhriz (HCTM) Orthopaedic Clinic. A total of 100 participants are being recruited, with 50 participants being assigned to each treatment group. Participants are being randomized into two groups, and independent personnel are responsible for the randomization and distribution of the study treatments. The study population consists of adults with type 2 diabetes mellitus and symptoms of DSPN who are being followed at the HCTM Orthopaedic Outpatient Clinic. DSPN is being assessed using the Toronto Clinical Neuropathy Scoring (TCNS) system.
Participants are receiving one of two oral treatment regimens for 12 consecutive weeks in addition to standard treatment for DSPN. The first group is receiving Bionerv-E+. Each tablet contains alpha-lipoic acid 300 mg, vitamin B12 500 micrograms, vitamin B1 39 mg, vitamin B6 8 mg, and vitamin E 100 IU. Participants in this group are taking two tablets once daily after a meal. The second group is receiving a vitamin B-complex. Each tablet contains vitamin B12 200 micrograms, vitamin B6 200 mg, and vitamin B1 100 mg. Participants in this group are taking three tablets once daily after a meal.
Participants are undergoing a baseline clinical assessment before starting treatment and are being reassessed after the 12-week treatment period. Neurological impairment in the lower limbs is being evaluated using the Neuropathy Impairment Score-Lower Limb (NIS-LL). The NIS-LL assesses motor, sensory, and reflex function and is being administered by a medical officer. Pain is being assessed using the Short Form McGill Pain Questionnaire (SF-MPQ). Quality of life is being evaluated using the Short Form-36 (SF-36), which assesses physical and mental aspects of health across eight domains.
The study is also investigating whether the treatments have different effects on systemic inflammation. Blood samples are being collected at recruitment and after the treatment period to measure high-sensitivity C-reactive protein (hs-CRP) and tumor necrosis factor-alpha (TNF-alpha). For each assessment, 10 mL of venous blood is being collected after overnight fasting. The inflammatory biomarkers are being measured using enzyme-linked immunosorbent assay (ELISA) methods.
The study is also evaluating wound healing in participants with diabetic foot ulcers. The study is focusing on eligible non-healing ulcers classified as Wagner grade 1 or 2. For wound assessment, researchers are documenting the wound history and evaluating wound size and clinical characteristics. Wound dimensions are being measured, and digital imaging is being used to calculate wound area at baseline and after treatment. Researchers are also monitoring clinical features associated with infection, including edema, erythema, discharge, pain, and fever. Wounds are being classified according to their location and evaluated using the Wagner classification. Debridement is being performed to remove hyperkeratosis and callus when applicable.
At recruitment, informed consent is being obtained before study procedures are performed. Baseline information being collected includes demographic and clinical data, neurological assessments, pain assessment, quality-of-life assessment, inflammatory biomarkers, and wound examination where applicable. Participants are receiving a follow-up telephone call during week 7 to support treatment adherence. They are returning for reassessment at week 13, after completing 12 weeks of treatment. At this visit, neurological impairment, pain, quality of life, inflammatory biomarkers, and wound status are being reassessed. Treatment adherence is also being evaluated using pill counts and medication diaries.
The study is using an intention-to-treat approach for data analysis. Descriptive statistics are being used to summarize demographic characteristics. The distribution of study data is being assessed for normality, followed by appropriate bivariate and multivariate analyses. The planned analyses include t-tests, Mann-Whitney U tests, paired comparisons, and multiple linear regression. A p-value below 0.05 is being considered statistically significant.
1,077 studies on the registry are indexed under Diabetic Foot; 224 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 845 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →BREGO Life Sciences is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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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.
Participants are receiving Bionerv E+ for 12 consecutive weeks in addition to standard treatment for diabetic symmetrical polyneuropathy. Each tablet contains alpha-lipoic acid 300 mg, vitamin B12 500 mcg, vitamin B1 39 mg, vitamin B6 8 mg, and vitamin E 100 IU. Participants are taking two tablets once daily after a meal.
Dietary Supplement: Alpha-Lipoic Acid, Vitamin B1, Vitamin B6, Vitamin B12, Vitamin E
Participants are receiving vitamin B-complex for 12 consecutive weeks in addition to standard treatment for diabetic symmetrical polyneuropathy. Each tablet contains vitamin B12 200 mcg, vitamin B6 200 mg, and vitamin B1 100 mg. Participants are taking three tablets once daily after a meal.
Dietary Supplement: Vitamin B1, Vitamin B6, Vitamin B12
Drug pages: Thioctic Acid · Thiamine · Vitamin B 6 · Pyridoxine · Vitamin B 12 · Vitamin E
Oral dietary supplement containing alpha-lipoic acid 300 mg, vitamin B1 39 mg, vitamin B6 8 mg, vitamin B12 500 mcg, and vitamin E 100 IU per tablet. Participants are taking two tablets once daily after a meal for 12 consecutive weeks, in addition to standard treatment for diabetic symmetrical polyneuropathy.
Also known as: Bionerv E+
Drug pages: Thiamine · Vitamin B 6 · Pyridoxine · Vitamin B 12
Oral dietary supplement containing vitamin B1 100 mg, vitamin B6 200 mg, and vitamin B12 200 mcg per tablet. Participants are taking three tablets once daily after a meal for 12 consecutive weeks, in addition to standard treatment for diabetic symmetrical polyneuropathy.
Change in Neuropathy Impairment Score-Lower Limb (NIS-LL)
Neurological impairment is being assessed using the Neuropathy Impairment Score-Lower Limb (NIS-LL), which evaluates muscle strength, sensation, and reflexes in the lower limbs. The total score ranges from 0 to 88, with higher scores indicating greater neurological impairment. Changes in NIS-LL scores from baseline to week 13 are being compared between the two treatment groups.
Time frame: Baseline and Week 13
Change in Neuropathic Pain Assessed by the Short Form McGill Pain Questionnaire (SF-MPQ)
Neuropathic pain is being assessed using the Short Form McGill Pain Questionnaire (SF-MPQ), which evaluates sensory and affective characteristics of pain. The questionnaire consists of 15 pain descriptors, each rated from 0 (none) to 3 (severe). Higher scores indicate greater pain severity. Changes in pain scores from baseline to week 13 are being compared between the two treatment groups.
Time frame: Baseline and Week 13
Change in Health-Related Quality of Life Assessed by the Short Form-36 (SF-36)
Health-related quality of life is being assessed using the Short Form-36 (SF-36) questionnaire, which evaluates eight domains of physical and mental health. Each domain is scored from 0 to 100, with higher scores indicating better health-related quality of life. Changes in SF-36 domain scores from baseline to week 13 are being compared between the two treatment groups.
Time frame: Baseline and Week 13
Change in Serum High-Sensitivity C-Reactive Protein (hs-CRP) Levels
Systemic inflammation is being evaluated by measuring serum high-sensitivity C-reactive protein (hs-CRP) levels. Blood samples are being collected after overnight fasting, and hs-CRP levels are being measured using an enzyme-linked immunosorbent assay (ELISA). Changes in hs-CRP levels from baseline to week 13 are being compared between the two treatment groups.
Time frame: Baseline and Week 13
Change in Serum Tumor Necrosis Factor-Alpha (TNF-alpha) Levels
Systemic inflammation is being evaluated by measuring serum tumor necrosis factor-alpha (TNF-alpha) levels. Blood samples are being collected after overnight fasting, and TNF-alpha levels are being measured using an enzyme-linked immunosorbent assay (ELISA). Changes in TNF-alpha levels from baseline to week 13 are being compared between the two treatment groups.
Time frame: Baseline and Week 13
Change in Diabetic Foot Ulcer Wound Area
Wound healing is being evaluated in participants with diabetic foot ulcers classified as Wagner grade 1 or 2. Wound area is being assessed through measurements of wound length and width, supported by digital imaging. Changes in wound area, measured in square centimetres (cm²), from baseline to week 13 are being compared between the two treatment groups. A smaller wound area indicates improvement in wound healing.
Time frame: Baseline and Week 13
Plan to share: No
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Started Jul 2025 (actual). Primary completion is estimated for Jan 2027, 18 months after the start.
Of 100 industry-sponsored interventional studies with no phase under Diabetic Foot, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's planned 18 months is below that.
Counting every sponsor, half of 340 studies reached it within 22 months; a quarter within 9 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Thioctic Acid · Thiamine · Vitamin B 6 · Pyridoxine · Vitamin B 12 · Vitamin E
BREGO Life Sciences