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Efficacy and Safety of Zizhu Ointment for Wagner Grade 2 Diabetic Foot Ulcers: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Trial.

Created on 28 Jul 2026

Authors

Xiao-Yu Li, Guo-Bin Liu, Yang You, Wei-Jing Fan

Published in

Chinese journal of integrative medicine. Jul 28, 2026. Epub Jul 28, 2026.

Abstract

To evaluate the clinical efficacy and safety of Zizhu Ointment (ZZO) in treating Wagner grade 2 diabetic foot ulcers (DFUs).
In this single-center, randomized, double-blind, placebo-controlled trial, using SPSS 26.0, a computer-generated random number sequence was used to randomly assign 154 patients with Wagner grade 2 DFUs in a 1:1 ratio to either the ZZO group (n=77) or the placebo control group (n=77). Both groups received conventional therapy and standard debridement. Patients received the assigned intervention as a topical application for 6 weeks, followed by a 6-week follow-up period. The primary outcome was the ulcer healing rate at 6 weeks. Secondary outcomes included Chinese medicine (CM) syndrome scores, transcutaneous oxygen pressure (TcPO2), wound blood flow, and safety indicators.
After 6 weeks, the ulcer healing rate was significantly higher in the ZZO group than in the placebo control group (67.59% ± 22.69% vs. 28.81% ± 15.80%, P<0.001). This superiority was maintained at the end of the 6-week follow-up (80.95% ±19.16% vs. 42.20% ±21.93%, P<0.001). The ZZO group also demonstrated significantly greater improvements in reducing ulcer area and depth, improving CM syndrome scores, TcPO2, and wound blood flow (all P<0.05). The incidence of adverse events was comparable between the two groups (P>0.05).
ZZO effectively promotes the healing of Wagner grade 2 DFUs, ameliorates the wound microenvironment and CM symptoms, and exhibits a favorable safety profile. (Registration No. ITMCTR2025000126).

PMID:
42518111
Bibliographic data and abstract were imported from PubMed on 28 Jul 2026.

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