drugset / Trial / NCT06531512

Evaluate the Efficacy and Safety of Xianglei Tangzu Gao for the Treatment of Wagner Grade II Diabetic Foot Ulcers

NCT06531512 ↗

Phase 2/3 Active not recruiting 120 enrolled Oneness Biotech Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a phase II/III seamless design, randomized, double-blind, paralleled-group, placebo-controlled study to evaluate the efficacy and safety of Xianglei Tangzu Gao for the treatment of Wagner grade II diabetic foot ulcers. The primary endpoint is the proportion of subjects with complete closure of target ulcer during the 16-week treatment phase.

Timeline

Start
2024-08-16
Primary completion
2026-05-08
Completion
2026-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Xianglei Tangzu Gao Traditional medicine (herbal / TCM) — Topical

Indications