Trial · NCT07877948
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
NCT07877948, Not applicable, Recruiting, BREGO Life Sciences
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT07877948. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07877948
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT07877948
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 100 participants, estimated
- Lead sponsor
- BREGO Life Sciences
- Conditions
- Diabetic Foot Ulcer (DFU), Diabetic Symmetrical Polyneuropathy
- Interventions
- Alpha-Lipoic Acid, Vitamin B1, Vitamin B6, Vitamin B12, Vitamin E, Vitamin B1, Vitamin B6, Vitamin B12
- First posted
- 2026-10-16
- Last updated
- 2026-10-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Neuropathy Impairment Score-Lower Limb (NIS-LL) | Baseline and Week 13 | 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. |
| Primary | Change in Neuropathic Pain Assessed by the Short Form McGill Pain Questionnaire (SF-MPQ) | Baseline and Week 13 | 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. |
| Primary | Change in Health-Related Quality of Life Assessed by the Short Form-36 (SF-36) | Baseline and Week 13 | 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. |
| Secondary | Change in Serum High-Sensitivity C-Reactive Protein (hs-CRP) Levels | Baseline and Week 13 | 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. |
| Secondary | Change in Serum Tumor Necrosis Factor-Alpha (TNF-alpha) Levels | Baseline and Week 13 | 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. |
| Secondary | Change in Diabetic Foot Ulcer Wound Area | Baseline and Week 13 | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07877948
GET https://conductscience.org/api/trials/v1/NCT07877948/registered