# Safety and Efficacy Study for the Treatment of Painful Diabetic Neuropathy

> **NCT01475786** · PHASE2 · COMPLETED · sponsor: **Helixmith Co., Ltd.** · enrollment: 104 (actual)

## Conditions studied

- Painful Diabetic Neuropathies

## Interventions

- **BIOLOGICAL:** Low Dose: 16 mg Engensis (VM202)
- **BIOLOGICAL:** High Dose: 32 mg Engensis (VM202)
- **OTHER:** Control- Placebo (normal saline)

## Key facts

- **NCT ID:** NCT01475786
- **Lead sponsor:** Helixmith Co., Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2012-08
- **Primary completion:** 2014-03-12
- **Final completion:** 2014-06
- **Target enrollment:** 104 (ACTUAL)
- **Last updated:** 2025-10-06


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01475786

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01475786, "Safety and Efficacy Study for the Treatment of Painful Diabetic Neuropathy". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT01475786. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*