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Zizhu Ointment More Than Doubles Healing Rate in Wagner Grade 2 Diabetic Foot Ulcers
In a randomized placebo-controlled trial, patients with Wagner grade 2 diabetic foot ulcers treated with topical Zizhu Ointment achieved a healing rate of 67.59% at six weeks, compared with 28.81% in the placebo group — a difference of nearly 39 percentage points (P<0.001). This substantial margin was sustained through a subsequent six-week follow-up period, and the ointment’s safety profile was comparable to placebo.
What Was Studied
The trial investigated whether Zizhu Ointment (ZZO), a topical traditional Chinese medicine formulation, could improve wound healing in patients with Wagner grade 2 diabetic foot ulcers when added to standard care. The primary outcome was the ulcer healing rate measured at six weeks of treatment, with secondary outcomes capturing wound microenvironment parameters, Chinese medicine syndrome scores, and safety indicators.
How It Was Studied
This was a single-center, randomized, double-blind, placebo-controlled trial enrolling 154 patients with confirmed Wagner grade 2 diabetic foot ulcers, allocated in a 1:1 ratio to either the ZZO group or a placebo control group (n=77 per arm) using a computer-generated random number sequence. Both groups received conventional therapy and standard wound debridement as a background treatment; the assigned topical ointment was applied for six weeks. Following the active treatment phase, participants entered a six-week observational follow-up, bringing the total study duration to 12 weeks. Secondary assessments included transcutaneous oxygen pressure (TcPO2), wound blood flow measurement, and Chinese medicine syndrome scoring.
What Was Observed
- Primary outcome — healing rate at 6 weeks: The ZZO group achieved a mean ulcer healing rate of 67.59% (±22.69%), compared with 28.81% (±15.80%) in the placebo group — a difference of approximately 39 percentage points that was highly statistically significant (P<0.001), indicating a markedly faster trajectory of wound closure with active treatment.
- Durability at 12 weeks: The healing advantage persisted through the end of the follow-up period, with ZZO-treated patients reaching 80.95% (±19.16%) healing versus 42.20% (±21.93%) in the placebo group (P<0.001), suggesting the effect is not simply accelerated early healing but reflects a meaningful difference in overall wound resolution.
- Wound microenvironment and ulcer dimensions: ZZO-treated patients showed significantly greater reductions in ulcer area and depth, as well as improvements in TcPO2 and wound blood flow — all reaching statistical significance (all P<0.05) — pointing to measurable improvements in local tissue oxygenation and perfusion alongside structural healing.
- Safety: The incidence of adverse events was similar between the two groups (P>0.05), providing no evidence of increased harm attributable to ZZO over the 12-week observation window.
Why This Matters
Diabetic foot ulcers at Wagner grade 2 represent a clinically significant category of wounds with meaningful risk of deterioration, and the search for effective adjunct wound therapies remains active. This trial offers randomized controlled evidence that a topical traditional Chinese medicine formulation can substantially increase healing rates and improve wound microenvironment parameters when added to conventional care. The findings provide a foundation for larger, multi-center studies needed to determine whether these results generalize across different patient populations and clinical settings.
How to Read This Result
Although the observed effect size is large and the trial is well-structured, the single-center design limits how broadly these findings can be applied, blinding fidelity is not confirmed in the abstract, and the durability of benefit beyond 12 weeks remains unknown — all factors that warrant caution before drawing definitive conclusions.
Limitations
The abstract does not explicitly report study limitations.