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

NCT06531512 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-07-02

No results posted yet for this study

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

DRUG

Xianglei Tangzu Gao

Active ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica

OTHER

Vehicle Cream

Cream base of Xianglei Tangzu Gao

Sponsors & Collaborators

  • Oneness Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Guang Ning · Ruijin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-16
Primary Completion
2025-12-31
Completion
2026-03-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06531512 on ClinicalTrials.gov