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<p>Diabetic foot ulcers (DFUs) are a debilitating complication of diabetes, characterized by impaired wound healing due to oxidative stress, inflammation, and poor tissue penetration of therapeutics, often resulting in chronic infections and amputations. Ellagic acid, a natural polyphenol with potent antioxidant, anti-inflammatory, and angiogenic properties, shows promise for DFU treatment but is limited by low solubility and skin permeability. This study aimed to develop an optimized ellagic acid-loaded transethosomal gel to enhance topical delivery and therapeutic efficacy. Transethosomes were prepared via cold ethanol injection, optimized using a 2³ factorial design, and incorporated into Carbopol 940 gel. The optimized formulation has a vesicle size of 191.5 ± 1.86&#xa0;nm, PDI of 0.164, zeta potential of -32.5 ± 1.7 mV, and entrapment efficiency of 94.5 ± 0.94%. <i>In vitro</i> release demonstrated sustained drug delivery (82.95 ± 1.20% at 12&#xa0;h) versus pure drug (68.34 ± 1.30%), while <i>ex vivo</i> permeation through rat skin showed an 11-fold higher flux (24.57 ± 0.52&#xa0;µg/cm²/h) than conventional gel. <i>In vivo</i> evaluation in streptozotocin-induced diabetic rat models illustrated complete wound healing (Wagner Grade 0) within 14 days following EA-TRE gel treatment, demonstrating a markedly superior performance compared to traditional formulations. Thus, the developed transethosomal gel system signifies a promising advanced delivery platform integrating enhanced skin penetration, controlled release, and superior therapeutic efficacy for managing DFUs.</p> Graphical Abstract <p></p>

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Design, Development, and Characterization of Ellagic Acid-Loaded Transethosomal Gel Using 23 Factorial Design Approach for the Management of Diabetic Foot Ulcer

  • 期刊论文

  • 发表日期：

    2026年1月16日

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  • Sanskriti Sarkar,
  • Amarjitsing Rajput,
  • Santosh Butle,
  • Pankaj Jain,
  • Shailesh S. Chalikwar

摘要

Diabetic foot ulcers (DFUs) are a debilitating complication of diabetes, characterized by impaired wound healing due to oxidative stress, inflammation, and poor tissue penetration of therapeutics, often resulting in chronic infections and amputations. Ellagic acid, a natural polyphenol with potent antioxidant, anti-inflammatory, and angiogenic properties, shows promise for DFU treatment but is limited by low solubility and skin permeability. This study aimed to develop an optimized ellagic acid-loaded transethosomal gel to enhance topical delivery and therapeutic efficacy. Transethosomes were prepared via cold ethanol injection, optimized using a 2³ factorial design, and incorporated into Carbopol 940 gel. The optimized formulation has a vesicle size of 191.5 ± 1.86 nm, PDI of 0.164, zeta potential of -32.5 ± 1.7 mV, and entrapment efficiency of 94.5 ± 0.94%. In vitro release demonstrated sustained drug delivery (82.95 ± 1.20% at 12 h) versus pure drug (68.34 ± 1.30%), while ex vivo permeation through rat skin showed an 11-fold higher flux (24.57 ± 0.52 µg/cm²/h) than conventional gel. In vivo evaluation in streptozotocin-induced diabetic rat models illustrated complete wound healing (Wagner Grade 0) within 14 days following EA-TRE gel treatment, demonstrating a markedly superior performance compared to traditional formulations. Thus, the developed transethosomal gel system signifies a promising advanced delivery platform integrating enhanced skin penetration, controlled release, and superior therapeutic efficacy for managing DFUs.

Graphical Abstract