Randomized Controlled Clinical Trial for the Treatment of Diabetic Foot Ulcers, Using Drug Loaded Nanofiberous Patch

سال انتشار: 1398
نوع سند: مقاله کنفرانسی
زبان: انگلیسی
مشاهده: 375

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شناسه ملی سند علمی:

ICEMU05_035

تاریخ نمایه سازی: 9 آذر 1398

چکیده مقاله:

The aim of the present study was development of a wound dressing based on bacterial cellulose nanofibers loaded with an antibacterial agent (doxycycline) (D) combined with an alleviating neuropathy drug (venlafaxine) (V).Material and Methods: Bacterial cellulose nanofiber sheets were loaded with D and V and their loading efficiency and release properties were studied. FTIR spectroscopy was used to show the possible interaction between the drugs and nanofibers. The optimized nanofibers were used in 20 subjects of diabetic patients randomized into case and control groups. Patients were treated two times per week with the drugs loaded nanofibers until the ulcer healed and followed for up to 12 weeks.Wound areas and free walking distance were calculated at every 2-week intervals following therapy.Michigan Neuropathy Screening Instrument (MNSI questionnaire) was utilized for assessment of diabetic neuropathy.Results: FTIR results showed no interaction between D, V and nanofibers. D loading efficiency in the optimum formulation was 37.8±1.6% while V was 48.0±1.9%. Ulcer size after 12 weeks showed no significant difference (p=0.32) between the treated group and the control group but this reduction was faster in the treated group. After treatment, abnormal responses in the MNSI questionnaire was decreased significantly in the group receiving D and V (4.2±0.98) when compared with the control group (8.3±4.1) (p value<0.05). Pathologic studies of the skin after using nanofibers presented plenty of polymorphonuclear chronic inflammatory cells, and formation of new capillary bed.Conclusion:The patches loaded with D and V may be talented in faster healing and reduction of neuropathy of diabetic foot ulcer.

نویسندگان

Rokhsareh Meamar

Isfahan Clinical Toxicology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.

Jaleh Varshosaz

Department of Pharmaceutics, School of Pharmacy and Pharmaceutical Sciences Isfahan University of Medical Sciences, Isfahan, Iran