Topical pyroligneous extract hydrogel may improve wound shrinkage in diabetic foot ulcers
This first-in-human randomized controlled trial evaluated a topical hydrogel containing 150 µg/g pyroligneous extract in sixteen volunteers with diabetic foot ulcers. The comparator was a placebo hydrogel, and the follow-up period was 13 weeks. Three participants dropped out during the study.
The primary outcome of wound shrinkage was significantly higher in the treatment group than the control group from Week 7 onwards. Estimated half-lives of wound healing were 4-7 days in the treatment group versus 5-15 days in the control group. Swab cultures showed a decreased number of species of on-wounded site pathogens and a decreased number of wounds with positive culture after treatment.
mRNA expression of transdermal growth factor-β 1 was significantly increased in the treatment group compared with placebo. mRNA expression of tumour necrosis factor-α decreased in the treatment group compared with placebo. No skin irritation was found in all participants, and no serious adverse events were reported. However, absolute numbers for outcomes were not reported.
The abstract states the extract may reduce the risk of infection and may decrease inflammatory response, indicating uncertainty regarding causality. This first-in-human study has a small sample size of 16 volunteers and three dropouts. Practice relevance was not reported in the source material.