Perilesional injections of human platelet lysate versus platelet poor plasma for the treatment of diabetic foot ulcers: A double-blinded prospective clinical trial

被引:11
作者
Alhawari, Hussam [1 ]
Jafar, Hanan [2 ,3 ]
Al Soudi, Mohammad [4 ]
Abu Ameereh, Lena [2 ]
Fawaris, Maram [2 ]
Saleh, Mohanad [2 ]
Aladwan, Safwan [5 ]
Younes, Nidal [6 ]
Awidi, Abdalla [2 ,7 ,8 ,9 ]
机构
[1] Univ Jordan, Sch Med, Dept Internal Med, Amman, Jordan
[2] Univ Jordan, Cell Therapy Ctr, Amman, Jordan
[3] Univ Jordan, Sch Med, Dept Anat & Histol, Amman, Jordan
[4] Univ Jordan, Sch Med, Amman, Jordan
[5] Al Ahliyya Amman Univ, Fac Allied Med Sci, Amman, Jordan
[6] Univ Jordan, Sch Med, Dept Surg, Amman, Jordan
[7] Univ Jordan, Sch Med, Dept Internal Med Hematol Oncol, Amman, Jordan
[8] Jordan Univ Hosp, Dept Hematol Oncol, Amman, Jordan
[9] Univ Jordan, Cell Therapy Ctr, Amman 11942, Jordan
关键词
diabetes; foot ulcers; platelet lysate; regenerative medicine; wound healing; CLASSIFICATION-SYSTEM; RICH PLASMA; RISK; INFECTION; ISCHEMIA;
D O I
10.1111/iwj.14186
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
Diabetic foot ulcer (DFU) is a major cause of morbidity, non-traumatic lower limb amputation in diabetic patients and a high-cost burden on the healthcare system. New therapeutic products are increasingly tested. Platelet-rich plasma (PRP) and human platelet lysate (hPL) are reported to be useful. This trial was conducted to test whether the healing effect of hPL in chronic DFU was due to plasma or platelet lysates in a prospective double-blind design. Autologous PRP was obtained from citrated blood, lysed, and used as drug 1 (active product). The platelet-poor plasma (PPP) was used as a drug 2 (placebo). Ten patients were enrolled in arm 1 and 9 in arm 2. The drugs were injected perilesionally every 2 weeks for a total of sixinjections. Adverse events were recorded until Week 14. The DFUs were scored per the Texas and Wegner systems. No patient showed any major adverse events. Some reported local pain post-injection. Wound healing was achieved in the hPL group in 9/10 of patients at a mean of 35.1 days. In the PPP group, no patient had healed by Day 84. The difference was statistically significant at P < 0.00001. We conclude that autologous hPL is safe and highly effective in healing chronic DFU and is superior to autologous PPP.
引用
收藏
页码:3116 / 3122
页数:7
相关论文
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DIABETIC MEDICINE, 2016, 33 (11) :1493-1498