Peer-reviewed clinical trial published in the Journal of Wound Care highlights botanical innovation in diabetic wound management
MIAMI, July 22, 2025 /PRNewswire/ — A newly published, multicenter clinical trial in the Journal of Wound Care presents promising evidence supporting the use of a botanical-based hydrogel for the management of diabetic foot ulcers (DFUs)—a serious complication associated with limb amputation, prolonged hospitalization, and diminished quality of life for millions of people with diabetes.
Clinical Breakthrough in Diabetic Foot Ulcer Care: Botanical-Based Gel Shows Strong Potential in Healing and Pain Reduction
The study, “Healing wounds with a multimodal botanical hydrogel: a clinical outcomes comparison study,” evaluated the performance of LAVIOR Diabetic Wound Gel, a botanical-based topical formulation, compared to a widely used standard hydrogel. Conducted across five U.S. outpatient wound care centers, this randomized, double-blind, controlled trial enrolled 65 patients with chronic, hard-to-heal DFUs.
Understanding the Clinical Need
DFUs affect up to 25% of people with diabetes during their lifetime and are a leading cause of non-traumatic lower-limb amputations. Healing is often complicated by poor blood flow, chronic inflammation, and increased risk of infection, making effective, patient-friendly treatments an urgent clinical priority.
Key Study Insights
The study confirmed that the botanical-based hydrogel performed at least as well as a standard hydrogel in overall healing outcomes. Notably, the botanical gel group showed greater wound surface area reduction and significantly better pain relief, both critical factors in improving patient adherence and enhancing healing potential.
While wound closure rates and quality of life improvements were comparable between groups, the botanical gel’s performance in pain management suggests a meaningful advantage in clinical practice. These findings support the role of botanical-based therapies as a valuable addition to diabetic wound care.
Key Findings at a Glance
- Non-inferiority confirmed: Comparable healing outcomes to standard hydrogel
- Greater wound surface area reduction: Significant improvement at Week 3 (p = 0.036)
- Superior pain reduction: Marked improvement in Weeks 1–4 (p < 0.001)
- Improved patient-reported quality of life: Significant gains by Week 5 (p = 0.001)
Conclusion
This randomized, controlled study highlights the potential of botanical-based wound care in diabetic foot ulcer management. While both hydrogels delivered positive outcomes, LAVIOR Diabetic Wound Gel demonstrated superior pain reduction and a trend toward faster wound healing. These results support further research and clinical consideration of botanical-based options for DFU care.
Publication & Authors
Journal of Wound Care Publication: https://doi.org/10.12968/jowc.2025.0185
Sung Ho Steve Bae, Windy Cole, Imaze M. Davis, Dmitry Sandler, J. David Warren, Janet S. Mackenzie
About Lavior Pharma Inc.
Lavior Pharma Inc. develops innovative, botanical-based wound care solutions designed to support healthcare professionals in managing chronic wounds. Leveraging natural botanical ingredients with advanced formulation science, Lavior delivers products aligned with evidence-based wound care practices worldwide.
Media Contact:
Anabelle Savion
305-627-3680
[email protected]
www.lavior.com
SOURCE Lavior