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Case Series/Study

(CS-093) Optimizing Wound Bed and Diabetic Foot Ulcer Healing with *Proprietary Natural Herbal Cream – A Case Series in US

Thursday, May 16, 2024

7:30 PM – 8:30 PM East Coast USA Time

Jui-Ching Chen, Pharmacist

Introduction: Diabetic foot ulcer (DFU) has been reported to be 13% of American diabetic patients. However, issues from the current wound dressings have been noted, i.e. poor moisture management, inadequate wound bed preparation, limited antimicrobial properties, and inadequate healing stimulating capabilities. A *proprietary natural herbal formulation with novel mechanism of action was previously studied in a randomized controlled trial (RCT) with 236 subjects and demonstrated significantly better healing compared to hydrofiber dressings (p< 0.001). We attempt to evaluate its efficacy in hard-to-heal DFUs in an Ohio-based clinic.

Methods: DFUs not responsive to standard care at least 6 weeks with mild or no infection and adequate blood perfusion were eligible. After receiving debridement at the clinic, the *proprietary natural herbal cream was applied twice daily by patients at home until healing or for up to 20 weeks. The wound closure and percentage change of slough, granulation tissue, epithelization and eschar were observed at every weekly or bi-weekly visit at the clinic.

Results: Wagner Grade 2 DFU patients with baseline HbA_1c 6.5% to 11.8% who were non-responsive to standard care after 6 weeks were included in the study. The size of DFUs ranged from 1.39 cm² to 5.5 cm². After using the proprietary natural herbal cream for 1-3 weeks, patients and we soon started observing obvious change of the ulcer environment rapidly, particularly in increasing granulation tissues and promote healing of DFUs in 2 to 4 weeks the earliest. Particularly, it is worth noting that after the proprietary cream treatment started, a DFU aged 58 weeks healed in only 2 weeks.

Discussion:

Unlike other medical dressing or hydrogels, the novel mechanism of macrophage regulation by the *proprietary cream is able to dually repair tissue by optimizing the wound bed and then promoting healing. The observation and results align with previous RCT results and also real-world cases collected from Egypt, Malaysia, Taiwan, and India. This sheds some light on future treatment prospects.