Mohammadi Mohammad Hossein, Molavi Behnam, Mohammadi Saeed, Nikbakht Mohsen, Mohammadi Ashraf Malek, Mostafaei Shayan, Norooznezhad Amir Hossein, Ghorbani Abdegah Ali, Ghavamzadeh Ardeshir
BMT and Cell Therapy Center of Taleghani Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Surgery Department, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Transfus Apher Sci. 2017 Apr;56(2):160-164. doi: 10.1016/j.transci.2016.10.020. Epub 2016 Nov 2.
The aim of the present study was to evaluate the effectiveness of using autologous platelet-rich plasma (PRP) gel for treatment of diabetic foot ulcer (DFU) during the first 4 weeks of the treatment. In this longitudinal and single-arm trial, 100 patients were randomly selected after meeting certain inclusion and exclusion criteria; of these 100 patients, 70 (70%) were enrolled in the trial. After the primary care actions such as wound debridement, the area of each wound was calculated and recorded. The PRP therapy (2mL/cm of ulcers) was performed weekly until the healing time for each patient. We used one sample T-test for healing wounds and Bootstrap resampling approach for reporting confidence interval with 1000 Bootstrap samples. The p-value<0.05 were considered statistically significant. The mean (SD) of DFU duration was 19.71 weeks (4.94) for units sampling. The ratio of subjects who withdrew from the study was calculated to be 2 (2.8%). Average area of 71 ulcers in the mentioned number of cases was calculated to be 6.11cm (SD: 4.37). Also, the mean, median (SD) of healing time was 8.7, 8 weeks (SD: 3.93) except for 2 mentioned cases. According to one sample T-test, wound area (cm), on average, significantly decreased to 51.9% (CI: 46.7-57.1) through the first four weeks of therapy. Furthermore, significant correlation (0.22) was not found between area of ulcers and healing duration (p-value>0.5). According to the results, PRP could be considered as a candidate treatment for non-healing DFUs as it may prevent future complications such as amputation or death in this pathological phenomenon.
本研究的目的是评估在治疗的前4周使用自体富血小板血浆（PRP）凝胶治疗糖尿病足溃疡（DFU）的有效性。在这项纵向单臂试验中，100名患者在符合特定纳入和排除标准后被随机选择；在这100名患者中，70名（70%）被纳入试验。在进行伤口清创等初级护理措施后，计算并记录每个伤口的面积。每周进行PRP治疗（2mL/cm溃疡面积），直至每位患者伤口愈合。我们对愈合伤口使用单样本T检验，并采用Bootstrap重采样方法，通过1000次Bootstrap样本报告置信区间。p值<0.05被认为具有统计学意义。抽样单元的DFU持续时间平均（标准差）为19.71周（4.94）。退出研究的受试者比例经计算为2名（2.8%）。上述病例中71处溃疡的平均面积经计算为6.11cm²（标准差：4.37）。此外，除上述2例病例外，愈合时间的均值、中位数（标准差）分别为8.7周、8周（标准差：3.93）。根据单样本T检验，在治疗的前四周，伤口面积（cm²）平均显著减小至51.9%（置信区间：46.7 - 57.1）。此外，未发现溃疡面积与愈合持续时间之间存在显著相关性（0.22）（p值>0.5）。根据结果，PRP可被视为不愈合DFU的候选治疗方法，因为它可能预防这种病理现象中未来的并发症，如截肢或死亡。
