NCT06531512

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

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Oneness Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DRUG	Xianglei Tangzu Gao	Active ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica
OTHER	Vehicle Cream	Cream base of Xianglei Tangzu Gao

Timeline

• Start date: 2024-08-16
• Primary completion: 2025-12-01
• Completion: 2026-03-01
• First posted: 2024-08-01
• Last updated: 2025-07-02

Locations

16 sites across 1 country: China

Regulatory

• FDA-regulated drug study