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Background <p>Diabetic foot ulcer (DFU) is a debilitating complication of diabetes mellitus (DM). This study aimed to compare the impact of cilostazol alone or with selenium on wound healing in non-ischemic DFU patients<b>. </b></p> Methods <p>A randomized controlled trial was conducted on 69 DFU patients. Eligible DFU patients were randomized to; Group1 (n = 23), received standard care only; Group2 (n = 23) received cilostazol plus standard care, Group3 (n = 23) received cilostazol/ selenium, plus standard care, all for 3&#xa0;months. The Kruskal–Wallis and chi-squared tests were used for comparison among groups. </p> Results <p>After 3&#xa0;months, as compared to controls, cilostazol alone or combined with selenium significantly reduced ulcer size parameters (length, width and depth) with <i>p</i> = 0.038, 0.000 and 0.001 respectively. The mean ulcer length, width, and depth in Group1 was reduced by (-1.46&#xa0;cm, -0.184&#xa0;cm, and -0.261&#xa0;cm) respectively. Group2 showed reduction by (-2.704&#xa0;cm, -1.90&#xa0;cm and -0.608&#xa0;cm) respectively and Group3 were reduced by (-3.630&#xa0;cm, -2.24&#xa0;cm and -0.50&#xa0;cm) respectively. There was a complete response to treatment in 30% of group1, 65% of group2, and 43% of group3.</p> Conclusion <p>Cilostazol addition to standard wound care significantly improved DFU healing. Addition of selenium to cilostazol had an added benefit to DFU healing on ulcer length and HMMP-9 serum levels.</p> Trial registration <p>Clinicaltrials.gov registry (NCT06117436), retrospectively registered on October 19th, 2023.</p>

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Impact of Cilostazol versus Cilostazol and Selenium Combination on The Healing of Diabetic Foot Ulcer Patients: A Randomized Controlled Trial

  • 期刊论文

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  • 发表日期：

    2026年1月6日

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  • Hadeer Eid Eliwa,
  • Lamia M. El Wakeel,
  • Amr A. Mahfouz,
  • Rana Sayed

摘要

Background

Diabetic foot ulcer (DFU) is a debilitating complication of diabetes mellitus (DM). This study aimed to compare the impact of cilostazol alone or with selenium on wound healing in non-ischemic DFU patients.

Methods

A randomized controlled trial was conducted on 69 DFU patients. Eligible DFU patients were randomized to; Group1 (n = 23), received standard care only; Group2 (n = 23) received cilostazol plus standard care, Group3 (n = 23) received cilostazol/ selenium, plus standard care, all for 3 months. The Kruskal–Wallis and chi-squared tests were used for comparison among groups.

Results

After 3 months, as compared to controls, cilostazol alone or combined with selenium significantly reduced ulcer size parameters (length, width and depth) with p = 0.038, 0.000 and 0.001 respectively. The mean ulcer length, width, and depth in Group1 was reduced by (-1.46 cm, -0.184 cm, and -0.261 cm) respectively. Group2 showed reduction by (-2.704 cm, -1.90 cm and -0.608 cm) respectively and Group3 were reduced by (-3.630 cm, -2.24 cm and -0.50 cm) respectively. There was a complete response to treatment in 30% of group1, 65% of group2, and 43% of group3.

Conclusion

Cilostazol addition to standard wound care significantly improved DFU healing. Addition of selenium to cilostazol had an added benefit to DFU healing on ulcer length and HMMP-9 serum levels.

Trial registration

Clinicaltrials.gov registry (NCT06117436), retrospectively registered on October 19th, 2023.