article · Scientific Reports
Diabetic ulcers often fail to heal properly due to infection, fluid accumulation, and impaired vessel formation, sometimes resulting in gangrene or limb amputation. To address this, a multilayered wound patch was created from polylactic acid nanofibres loaded with three distinct therapeutics: phenytoin, simvastatin, and sildenafil citrate. Each drug occupies a separate layer to target different phases of the healing cycle. Laboratory tests demonstrated that the patches maintain their physical durability, breathability, porosity, and biocompatibility while releasing phenytoin and simvastatin over two weeks and sildenafil over three weeks. When tested in a diabetic rat model over three weeks, the therapeutic patches prompted complete wound closure. Histopathological analysis confirmed full tissue recovery, showing organised cell regeneration and structural healing without scar formation.
Diabetic foot ulcers represent a severe clinical challenge that frequently leads to prolonged tissue damage and limb amputation. Developing an advanced dressing that simultaneously addresses multiple stages of tissue repair through controlled, multi-drug delivery provides a potential route to accelerate healing, prevent tissue decay, and reduce surgical interventions for individuals living with diabetes.
This technology offers a potential advanced wound dressing application for healthcare providers managing chronic diabetic wounds. The research is at an applied preclinical stage, having demonstrated structural stability and complete tissue healing in a three-week diabetic rat trial. Translating this patch towards clinical use would require further evaluation in human trials to establish safety, manufacturing scalability, and practical efficacy in clinical environments.
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Impaired healing of diabetic ulcers is one of the major complications of diabetic patients due to high susceptibility to microbial infections, impaired lymphianogenesis, edema, and consequently impairing proper healing. This could even lead to much worse complications that include severe gangrene, trauma and finally limb amputation. Therefore, this study aims to develop a multilayered durable nanofibrous wound patch loaded with three promising drugs (phenytoin, sildenafil citrate and simvastatin) each in a separate layer to target a different wound healing phase. Polylactic acid was used for the preparation of the nanofibrous matrix of the wound patch, where each drug was incorporated in a separate layer during the preparation process. Drugs release profiles were studied over 3 weeks. Results showed that both phenytoin and simvastatin were released within 14 days while sildenafil continued till 21 days. Both physicochemical and mechanical characteristics of the patches were fully assessed as well as their biodegradability, swellability, breathability and porosity. Results showed that incorporation of drugs preserved the physicochemical and mechanical properties as well as porosity of the developed nanofibers. In addition, patches were evaluated for their biocompatibility and cell adhesion capability before being tested through in-vivo diabetic wound rat model induced by alloxan for three weeks. In vivo results showed that the patches were successful in inducing proper wound healing in diabetic rat model with overcoming the above-mentioned obstacles within 3 weeks. This was confirmed through assessing wound closure as well as from histopathological studies that showed complete healing with proper cell regeneration and arrangement without forming scars.
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DOI: 10.1038/s41598-023-29032-x
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