Combination Bionerv E+ vs Vitamin B Complex in Type 2 Diabetes with DSPN and Foot Ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-centre study compares two treatment regimens in adults with type 2 diabetes and diabetic symmetric polyneuropathy who also have non-healing foot ulcers. Participants are randomized to receive either Bionerv E+ (alpha-lipoic acid plus vitamins B1, B6, B12, and vitamin E) or a vitamin B complex (B1, B6, B12) for a specified period. The primary aim is to see if the Bionerv E+ combination provides greater improvement in neuropathy symptoms. Secondary observations include effects on wound healing in the context of a Wagner 1-2 foot ulcer and adequate blood flow metrics. The study is conducted at a single center in Malaysia with about 100 participants to be enrolled.

Why it matters

Who can join: the full rules

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 ≥ 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.

Where it's running

• Hospital Canselor Tuanku Muhriz (HCTM) UKM
  Cheras, Kuala Lumpur, Malaysia Recruiting

Study contacts

• Study coordinator: Rose Farahaisyah Munawar
• Email: rose.aisyah@brego.com.my
• Phone: +60391349797

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.