Ahmed Elsaid1, Mohammed El-Said1, Sameh Emile2, Mohamed Youssef1, Wael Khafagy1, Ayman Elshobaky1. 1. General Surgery Department, Mansoura University Hospitals, Mansoura University, PO: 35516, Mansoura, Egypt. 2. General Surgery Department, Mansoura University Hospitals, Mansoura University, PO: 35516, Mansoura, Egypt. sameh200@hotmail.com.
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.
RCT Entities:
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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