NCT07877948Recruiting

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

Comparative Study of Combination Treatment of Vitamin B Complex, Alpha Lipoic Acid and Vitamin E Versus Vitamin B Complex in Treatment of Diabetic Polyneuropathy in Type 2 Diabetic Patients and Its Effect on Wound Healing

Source: ClinicalTrials.gov · Last updated 16 Oct 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Study type: Interventional
Enrollment: 100 (estimated)
First submitted: 11 Oct 2026
Start date: Jul 2025
Primary completion date: Jan 2027
Lead sponsor: BREGO Life Sciences
Diseases: Type 2 diabetes
NCT number: NCT07877948

What you commit to

Study type: Interventional
Planned participants: 100
From Jul 2025 to the primary completion date, Jan 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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.

Who the study is looking for

Aged 18 years and above
Diagnosed with Type 2 Diabetes Mellitus
HbA1C of \<8%
Symptoms of DSPN attributed by diabetes mellitus using Toronto Clinical Neuropathy Scoring (TCNS)
No recent changes of medications for DSPN for the last 3 months
Neuropathy Impairment Score (NIS) for lower limbs ≥ 2 points
DFU is classified as Wagner 1 or 2 on the Wagner classification system.
Patients with type 1 or type 2 diabetes with a non-healing foot ulcer of at least 4 weeks' duration.
If more than one non-healing wound is present, the largest wounds that are classified as a Wagner 1 or 2 will be selected.
The index ulcer has to be clinically non-infected.
Ankle Brachial Index (ABI) higher than or equal to 0.7.
Index foot ulcers that are located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces).
Wound area (length X width) measurement between 2 cm2 and 20 cm2.
Non-use of drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive, and cytotoxic agents.
No smoking, alcohol or drug addiction.
Approved, informed, signed consent.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Hospital Canselor Tuanku Muhriz (HCTM) UKM Coordinator of this site? Confirm its status	Cheras	Malaysia	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.