Perilesional injections of human platelet lysate versus platelet poor plasma for the treatment of diabetic foot ulcers: A double-blinded prospective clinical trial.
Hussam AlhawariHanan JafarMohammad Al SoudiLena Abu AmeerehMaram FawarisMohanad SalehSafwan AladwanNidal YounesAbdalla AwidiPublished in: International wound journal (2023)
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.
Keyphrases
- platelet rich plasma
- lower limb
- clinical trial
- double blind
- endothelial cells
- phase iii
- placebo controlled
- case report
- end stage renal disease
- study protocol
- wound healing
- newly diagnosed
- spinal cord injury
- randomized controlled trial
- pluripotent stem cells
- drug induced
- induced pluripotent stem cells
- pain management
- chronic kidney disease
- prognostic factors
- open label