Elsevier

Annals of Vascular Surgery

Volume 82, May 2022, Pages 165-171
Annals of Vascular Surgery

Autologous Platelet Rich Plasma Promotes the Healing of Non-Ischemic Diabetic Foot Ulcers. A Randomized Controlled Trial

https://doi.org/10.1016/j.avsg.2021.10.061Get rights and content

Background

DFU (diabetic foot ulcer) represents a major global health and socioeconomic problem and a leading cause of lower limb amputation. Although many therapies have been tested, none has been proposed as a dominant wound healing treatment. We performed a prospective randomized controlled study in order to assess the role of autologous platelet rich plasma (PRP) for the promotion of non-ischemic DFU healing.

Methods

After full vascular assessment, a total of 80 patients were randomized in 1:1 ratio to receive either PRP injection in the healing edge and the floor of the targeted DFU (Group A), or have usual standard care with moist dressing with or without collagenase ointment (Group B). We calculated the total surface area (TSA) for the ulcer in both groups (cm2) before, after treatment and every week up to 12 weeks of follow-up.

Results

A total of 4 patients (10%) experienced major amputation in group B, while no major amputation was performed in patients of Group A (P< 0.001). A ≥ 50% reduction in TSA occurred earlier in Group A (at 2.5 weeks), compared to Group B (4.5 weeks); P < 0.001. Complete wound healing rate was 95% (n = 38) and it was achieved earlier (6th week) for patients of group A, contrary to 77.8% (n = 28) of patients (9th week) for Group B (P < 0.001). Superficial wound infection was noted in 10% (n = 4) of the cases in the PRP arm, while in group B, 45% (n = 18) of cases had a variable degree of infection ranging from superficial to deep wound infection and cellulites (P < 0.001). PRP treatment was cost-effective, with 247.50$ vs. 437.50$ for the total cost of treatment for patients of Group B.

Conclusion

PRP is a cost-beneficial novel modality of treatment that can accelerate wound healing and decrease the rate of local infection in DFU, compared to other conventional treatment modalities.

Section snippets

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.

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