Bae SHS, Cole W, Davis IM, Sandler D, Warren JD, Mackenzie JS. Healing wounds with a multimodal botanical hydrogel: a clinical outcomes comparison study. Journal of Wound Care. 2025;34(Sup7):S5–S12. DOI: 10.12968/jowc.2025.0185 · PubMed: PMID 40632779
Key findings at a glance
- Study type: prospective, double-blinded, randomized controlled trial in patients with diabetic foot wounds, published in the peer-reviewed Journal of Wound Care (July 2025).
- Product studied: LAVIOR Diabetic Wound Gel, a botanical hydrogel containing Inula viscosa (AGS-RIED) extract, compared with a widely used standard hydrogel. It is sold today as Lavior Diabetic Wound Hydrogel.
- Patients: 65 (34 LAVIOR, 31 comparator), treated and assessed weekly for six weeks.
- Primary result: LAVIOR Diabetic Wound Gel was non-inferior to the standard hydrogel: patients healed at least as well.
- Pain: significantly greater pain reduction with LAVIOR during follow-up weeks 1–4 (p<0.001).
- Quality of life: significantly greater improvement on the Diabetic Foot Scale by study end (p=0.001).
- Wound area: mean wound area fell from 7.32 cm² to 2.24 cm² with LAVIOR versus 8.18 cm² to 5.16 cm² with the comparator; this difference was not statistically significant (p=0.127).
- Closure time: comparable between the two groups.
Authors
- Sung Ho Steve Bae, DPM — Baefoot Podiatry, Miami, Florida
- Windy Cole, DPM, CWSP, FFPM (Glasg) — Adjunct Professor, Kent State University College of Podiatric Medicine
- Imaze M Davis, DPM, MBA, CWSP — Scientific Advisory Board Member, Lavior Pharma Inc
- Dmitry Sandler, DPM, FACFAS, WCC — Scientific Advisory Board Member, Lavior Pharma Inc
- J David Warren, PhD — Lavior Pharma Inc
- Janet S Mackenzie, MD, CWSP — Lavior Pharma Inc
Disclosure: four of the six authors are affiliated with Lavior Pharma Inc, the manufacturer of LAVIOR Diabetic Wound Gel.
Published abstract
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.
Read the full study
Full text: Journal of Wound Care (MA Healthcare). Clinicians can also request a copy at info@lavior.com.
