Healing wounds with a multimodal botanical hydrogel: a clinical outcomes comparison study.

OBJECTIVE

Diabetic foot wounds pose many challenges during the healing process and often become hard-to-heal (chronic) wounds. This study compared a novel botanical hydrogel with a widely used hydrogel to determine both its non-inferiority and impact on the progress of diabetic foot wounds.

METHOD: The study was a prospective, double-blinded, randomised controlled study comparing healing outcomes. There were two cohorts: one treated with LAVIOR Diabetic Wound Gel (LDWG; Lavior Pharma Inc., US), which contains botanical extracts, and the other treated with SoloSite Wound Gel (SSWG) (Smith+Nephew Inc., US). The wounds were treated and evaluated weekly over a six-week period. Subjective patient data were collected with the Diabetic Foot Scale (DFS) at each visit.

RESULTS

The study cohort comprised 65 patients: 34 patients treated with LDWG, and 31 patients treated with SSWG. The patients treated with LDWG demonstrated at least as much progress in healing as those treated with SSWG. There was a greater reduction in wound surface area in the LDWG group from baseline to the end of the study (7.32cm2 to 2.24cm2) than in the SSWG group (8.18cm2 to 5.16cm2) (p=0.127). Reduction in pain was significantly improved in wounds treated with LDWG compared with SSWG (during follow-up weeks 1-4; p<0.001; week 5 was not statistically significant). The LDWG group demonstrated significantly greater improvement in DFS scores by the end of the study (scores of 192 versus 219, respectively, compared with the SSWG group; p=0.001). Wound closure times were comparable between the two groups.

CONCLUSION

In this study, LDWG demonstrated non-inferiority to SSWG; better results were observed in pain reduction and surface area reduction. Further study is indicated.