Autologous Platelet Rich Plasma Promotes the Healing of Non-Ischemic Diabetic Foot Ulcers. A Randomized Controlled Trial
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INTRODUCTION
Diabetes mellitus (DM) is a major health problem with an estimated 7.8% contemporary prevalence in the United States. DM is currently showing an alarming rise with a more than 50% increase over the past 15 years, not including a large population group in whom it is undiagnosed.1 Among its major complications, diabetic foot ulceration (DFU) is an unavoidable event for up to 25% of the diabetic patients, who are 15 to 30 times more likely to undergo an amputation compared to non-diabetics.2 It
Study Design, Primary and Secondary Endpoints
We performed a single-center, prospective, (RCT) including 80 patients who presented with DFU in the Department of Vascular Surgery, Cairo University, Egypt between January 2018 and June 2018. Patients were randomized in a 1:1 ratio to receive local application of PRP injection in the healing edge and the floor of the targeted DFU (Group A), or have usual standard wound care with moist dressing with or without collagenase ointment (Group B). The randomization process included cards with numbers
STATISTICAL ANALYSIS
Quantitative data was summarized using mean, standard deviation, median, minimum and maximum and frequency (count) and relative frequency (percentage) for categorical data, according to data distribution. Comparisons between quantitative variables were done using the non-parametric Mann-Whitney test. For comparing categorical data, Chi-square (χ2) or Fischer exact test was performed. P values less than 0.05 were considered as statistically significant. Data were coded and entered using the
RESULTS
A total of 40 patients (n = 28, 70% males) were included in Group A, with a mean age of 54.9 ± 2.37 years and 40 patients (n = 34, 85% males) were included in Group B, with a mean age of 54.8 ± 3.9 years (p value not significant); Table I. All patients in both groups were on insulin, while 2 (5%) and 4 (10%) patients of Groups A and B, respectively were hypertensive. All 80 patients had no history of stroke or ischemic heart disease and clinical examination revealed pedal pulses. A total of 6
DISCUSSION
Our study has showed an accelerated DFU healing after local application of PRP, compared to standard wound care with moist dressing with or without collagenase ointment. PRP showed better results since the first week of application, compared to classical wound treatment. Interestingly, a ≥90% reduction in DFU occurred at 5 weeks, with complete wound healing 1 week later. The randomized nature of the study controlled for potential selection when recruiting patients and thus any differences
CONCLUSION
Our study, randomized in nature, showed evidence that local PRP application accelerates wound healing and may be a cost-beneficial treatment option in DFUs.
FUNDING
This work received no funding.
AUTHOR CONTRIBUTIONS
EH collected data and performed the analysis. All authors participated in drafting and critically revised the manuscript. All authors approved the final version of the manuscript
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Conflict of Interest: No conflict of interest.