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Randomized Controlled Trial on Autologous Platelet-Rich Plasma Versus Saline Dressing in Treatment of Non-healing Diabetic Foot Ulcers

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Abstract

Background

This randomized clinical trial was conducted to assess the role of platelet-rich plasma (PRP) gel as a treatment of clean non-healing diabetic foot ulcer (DFU) in comparison with regular dressing with saline as a control.

Methods

Patients with DFU were randomly assigned to one of two equal groups: group I received dressing with PRP gel and group II received regular saline dressing. The main outcomes of the study were percent reduction in the dimensions of the DFU, healing of DFU, and complications at 20 weeks of follow-up.

Results

Twenty-four patients were included to the study. The mean age of patients was 55.2 ± 6.4 years. Only three (25%) patients in group I achieved complete healing versus none of group II patients. In total, 8.3% of group I and 41.6% of group II patients did not show any response to treatment. The percent of reduction in the longitudinal and horizontal dimensions of the DFU was significantly greater in group I than group II (43.2% vs 4.1%) and (42.3% vs 8.2%), respectively. The time required to maximum healing was significantly shorter in group I than group II (6.3 ± 2.1 vs 10.4 ± 1.7 weeks, P < 0.0001).

Conclusion

The use of PRP gel as a dressing for chronic DFU resulted in a more significant reduction in the size of the ulcer when compared to regular saline dressing. Also the time to reach the point of maximal possible healing with the least wound dimensions was significantly shorter when using PRP as a dressing protocol.

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Funding

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Author notes

  1. Ahmed Elsaid and Mohammed El-Said contributed equally to the study and both are considered co-first Author.

Authors and Affiliations

  1. General Surgery Department, Mansoura University Hospitals, Mansoura University, PO: 35516, Mansoura, Egypt

    Ahmed Elsaid, Mohammed El-Said, Sameh Emile, Mohamed Youssef, Wael Khafagy & Ayman Elshobaky

Authors
  1. Ahmed Elsaid
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  2. Mohammed El-Said
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  3. Sameh Emile
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  4. Mohamed Youssef
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  5. Wael Khafagy
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  6. Ayman Elshobaky
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Contributions

AE and WK designed the study. AE and ME collected and analyzed the data and wrote the manuscript. SE and AE participated in data analysis and interpretation, drafting and critical revision of the manuscript. MY and WK contributed to data interpretation and critical revision of the manuscript.

Corresponding author

Correspondence to Sameh Emile.

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None to be disclosed by the authors.

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Informed consent was obtained from all individual participants included in the study.

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Elsaid, A., El-Said, M., Emile, S. et al. Randomized Controlled Trial on Autologous Platelet-Rich Plasma Versus Saline Dressing in Treatment of Non-healing Diabetic Foot Ulcers. World J Surg 44, 1294–1301 (2020). https://doi.org/10.1007/s00268-019-05316-0

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  • DOI: https://doi.org/10.1007/s00268-019-05316-0

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