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E-IJD® - ORIGINAL ARTICLE |
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| Year : 2022 | Volume
: 67
| Issue : 6 | Page : 834 |
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| A clinical study of efficacy of autologous Platelet-Rich Fibrin (PRF) in chronic non-healing ulcers |
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M Madhu, Manjunath Hulmani, AC Naveen Kumar, V Jagannath Kumar
Department of Dermatology, SSIMS and RC, Davangere, Karnataka, India
| Date of Web Publication | 23-Feb-2023 |
Correspondence Address:
M Madhu
Department of Dermatology, S S Hospital, NH-4 Bypass Road, Davangere - 577 005, Karnataka
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/ijd.ijd_204_22
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 Abstract | | |
Background: Chronic ulcers are defined as the breakdown of the epidermal and dermal tissue lasting for more than 6 weeks. There will be a lack of necessary growth factors in chronic non-healing ulcers. This study is aimed at accessing the efficacy of autologous platelet-rich fibrin in chronic non-healing ulcers. Aims and Objectives: To determine the efficacy of autologous platelet-rich fibrin in chronic non-healing ulcers and to compare the rate of healing in different ulcers based on aetiology. Methods: A hospital-based prospective study was conducted at the Department of Dermatology, Venereology, and Leprosy, at a tertiary care centre in Central Karnataka with 50 cases of chronic non-healing ulcers over 2 years. In each case baseline data including age and gender was collected and thorough general physical, local, and systemic examinations were done with the help of a predesigned proforma. PRF dressing was done weekly for 4 weeks with ulcer volume measured each time and improvement accessed. Results: In this study, the mean age of the study population was 43.56 ± 14.06 years, with 84% males. Good improvement in the volume of the ulcer was seen in 6 patients out of 50, moderate improvement was seen in 20 out of 50 patients and mild in the rest of the 24 patients. Improvement was more in the educated sector, more so in females and patients with trauma as the cause of ulcers without any comorbidities. Leprosy followed by diabetes was the main cause of chronic non-healing ulcers. Conclusions: This study shows that autologous platelet-rich fibrin therapy provides faster wound healing in chronic non-healing ulcers with no adverse events.
Keywords: Chronic ulcers, growth factors, platelet-rich fibrin, PRF
How to cite this article:
Madhu M, Hulmani M, Naveen Kumar A C, Kumar V J. A clinical study of efficacy of autologous Platelet-Rich Fibrin (PRF) in chronic non-healing ulcers. Indian J Dermatol 2022;67:834 |
How to cite this URL:
Madhu M, Hulmani M, Naveen Kumar A C, Kumar V J. A clinical study of efficacy of autologous Platelet-Rich Fibrin (PRF) in chronic non-healing ulcers. Indian J Dermatol [serial online] 2022 [cited 2023 Mar 31];67:834. Available from: https://www.e-ijd.org/text.asp?2022/67/6/834/370279 |
| Introduction | |  |
An ulcer is defined as a break in the continuity of covering epithelium, involving skin or mucous membrane and occurs as a result of molecular death.[1] Chronic ulcers or non-healing ulcers are defined as spontaneous or traumatic lesions, typically in lower extremities that are unresponsive to initial therapy or that persist despite appropriate care and do not proceed towards healing in a defined period with an underlying aetiology that may be related to systemic disease or local disorders.[2],[3]
Chronic non-healing ulcers can be due to various aetiologies like diabetes, leprosy, other sensory neuropathies, peripheral arterial occlusion disorders, varicose veins and trauma. Most non-healing ulcers lack growth factor production. Hence providing supplements will decrease the chances of non-healing.[4]
Current advanced therapies available include therapy to replace the deficient components such as autologous epidermis, allografts, and living skin equivalents.[5] Whereas, complementary therapies include hyperbaric oxygen, negative pressure, ultrasound-guided electrical stimulation, dermal matrix equivalents, exogenous growth factors and autologous growth factor/fibrin preparations.[6] Among the current advanced therapies available, the one that has gained attention is the use of platelet-rich fibrin, which brings about improved wound healing by neovascularization, by endothelial cell proliferation mediated by the growth factor, vascular endothelial growth factor (VEGF).[7]
There are studies in which they have done PRF in the specific type of ulcers, but there are way too few studies that have taken chronic non-healing ulcers as a whole. So, this being an easy and cost-effective method, the study of the efficacy of autologous platelet-rich fibrin in chronic non-healing ulcers as a whole gains significance.
| Aims and Objectives | | |
To determine the efficacy of autologous platelet-rich fibrin in chronic non-healing ulcers and to compare the rate of healing in different ulcers based on aetiology.
| Materials and Methods | | |
This is a hospital-based prospective cohort study of the efficacy of autologous platelet-rich fibrin in chronic non-healing ulcers. The study material consists of 50 cases of chronic non-healing ulcers.
Method of collection of data
A study group of about 50 patients with chronic non-healing ulcers belonging to both sexes were included in the prospective study after taking their consent. In each case, baseline data including age and gender was collected and thorough general physical, local and systemic examinations were done regarding chronic non-healing ulcers with the help of a predesigned proforma. PRF dressing was done weekly for 4 weeks with the volume of ulcer measured at each sitting. Improvement was assessed based on the following improvement scale where less than 25% improvement in the volume of the ulcer was taken as mild improvement, 25–50% as moderate improvement, 50–75% as good improvement and more than 75% as an excellent improvement.
Procedure
In each sitting for PRF preparation, a blood specimen was drawn from the patient intravenously following aseptic precautions and was transferred to 2 plain vacutainers equally and centrifuged immediately at 3000 rpm for 10 minutes. Following this, the middle fraction containing the fibrin clot was picked up after pouring out the platelet-poor plasma, with toothed forceps and was put on sterile gauze. Concurrently in each sitting, multiple photographs of the ulcer were taken, the length, breadth and depth of the ulcer measured and thorough debridement and cleaning of the wound were done. Following it the fibrin clot was squeezed and put on the floor of the ulcer and the dressing was done with the help of a sterile pad and gauze.
Ethics committee clearance taken on 07/11/2019 with reference IERB number 375-2019 Ref:IERB/OW. No. 214/2019.
| Results | | |
All 50 patients completed treatment and follow-up. In this study, the mean age of the study population was 43.56 ± 14.06 years, where 34% of them were aged between 31 to 40 years followed by 24% between 51 and 60 years of age, 84% of the recruited patients were males that is 42 out of 50 and the rest 16% that is 8 out of 50 were females and agriculturists contributed to 16% of the study group, followed by students who contributed to 12% of the study group and 10% each were either shopkeepers, businessmen or retired.
In this study, 26% of the patients were diabetic, 22% of the patients were hypertensive and 6% of the patients had varicose veins and 46% of the patients did not have any comorbidities and the cause of chronic non-healing ulcer was leprosy in 16 patients, followed by diabetic foot in 12 patients, and degenerative sensory neuropathy with trophic ulcer and trauma in 8 and 6 patients, respectively.
About 28% of patients had the ulcer for 42–47 days, 48% of patients had the ulcer for 48–56 days, 22% of patients had the ulcer for 57–72 days and 2% of patients had the ulcer for more than 72 days, a most common location of the ulcer was on the left great toe on the plantar aspect followed by the left medial malleolus and the right great toe on the plantar aspect and the mode of onset of the ulcer was gradual in 90% of patients and sudden in 10% of patients.
It was noted that good improvement in the volume of the ulcer was seen in 12% of patients (6 patients) [Figure 1] and [Figure 2], moderate improvement in 40% of patients (20 patients) and mild improvement in 48% of patients (24 patients) [Table 1]. Better improvement in the volume of the ulcer was noted in females when compared to males, that is 2 out of 6 female patients showed good improvement and among 5 patients who had sudden onset of ulcer, 3 showed good improvement in the volume of ulcer and all three had trauma as the cause of the ulcer. | Figure 1: 1st patient with good improvement (a) ulcer at first sitting (b) ulcer at 4th sitting
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 | Figure 2: 2nd patient with good improvement (a) ulcer at first sitting (b) ulcer at 4th sitting
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| Discussion | | |
Chronic wounds are characterized as having stalled somewhere in the progression to healing due to a variety of systemic and local factors including inadequate blood supply, high microbial burden, excess devitalized tissue, chronic venous insufficiency, senescent epithelial cells that are poorly responsive to cell signalling and decreased growth-factor production and response.[8]
Wound healing is essentially the same process for most tissues and involves a multitude of cellular and humoral components, including local influx and activation of platelets. The initial stimulus for the wound-healing process is the subsequent release of cytokines and growth factors. Platelets release a multitude of growth factors including platelet-derived growth factor (PDGF), a potent chemotactic agent, and transforming growth factor-beta, which stimulates the deposition of extracellular matrix.[9] One of the advances in regenerative technology is platelet-rich fibrin.[8]
In this study when it comes to improvement in the volume of ulcers noted from baseline to that after the fourth sitting, good improvement was seen in 12%, that is in 6 out of 50 patients, moderate improvement was seen in 40%, that is in 20 out of 50 patients and mild improvement was seen in 48%, that is 24 out of 50 patients.
Somani A et al.[10] observed an 85.51% ulcer area reduction in the PRF dressing group and only a 42.74% reduction in ulcer size when treated with saline dressing. In another study by Sarvajnamurthy et al.,[11] in which the mean duration of the healing of the chronic venous ulcers was 5.1 weeks, the mean percentage improvement in the area and volume of the ulcer was 94.7% and 95.6% respectively. Steenvoorde et al.[12] also had used the autologous PRF on a range of hard-to-heal wounds. They achieved full closure in eight of the ten observed wounds and a reduction in diameter by up to 66% in three wounds with a mean number of 2.2 applications. The mean treatment period was 4.2 weeks with no noticeable adverse effects. And O'Connell et al.[13] their study also observed the complete closure of wounds in 66.7% of the venous leg ulcer patients in 7.1 weeks with an average of two applications per patient and 44% complete closure was seen with a non-venous leg ulcer.
The difference in the improvement that we see in this study can be attributed to poor wound hygiene that's followed by the patients. To add to that, the majority in this study were agriculturists by occupation so there is a risk of repetitive injury and dust exposure leading to contamination and infection, which prolongs the duration of wound healing. In this study, it was noticed that patients with ulcers due to trauma had significantly better improvement than others. That is, 3 out of 6 patients with traumatic ulcers had good improvement. There was not much difference in improvement when other causes were considered.
| Conclusion | | |
This study demonstrates the application of an enhanced formulation of platelet-rich fibrin, which provides a rapid and consistent improvement in the healing of chronic wounds. In this study incidence of the chronic non-healing ulcer is comparatively higher among the males and those with comorbid conditions and are more common among agriculturists, wound healing was better in an educated group due to proper wound care and among patients with sudden onset of ulcer than those with gradual onset of ulcer and good improvement in the volume of the ulcer was seen in 12% of the patients, moderate improvement was seen 40% of patients and mild improvement was seen in 48% of patients.
The number of PRF dressing sittings can be increased to 6–8 to get even better improvement in the volume of ulcers.
This study shows that autologous platelet-rich fibrin therapy provides faster wound healing in chronic non-healing ulcers with no adverse events.
Acknowledgements
Thanks to all the patients who were included in this study for their wholehearted cooperation.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form, the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
| References | | |
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| 2. | San Sebastian KM, Lobato I, Hernández I, Burgos-Alonso N, Gomez-Fernandez MC, López JL, et al. Efficacy and safety of autologous platelet rich plasma for the treatment of vascular ulcers in primary care: Phase III study. BMC Fam Pract 2014;15:1-8. |
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| 7. | Barwell JR, Davies CE, Deacon J, Harvey K, Minor J, Sassano A, et al. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): Randomised controlled trial. Lancet 2004;363:1854-9. |
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| 10. | Somani A, Rai R. Comparison of efficacy of autologous platelet-rich fibrin versus saline dressing in chronic venous leg ulcers: A randomised controlled trial. J Cutan Aesthet Surg 2017;10:8-12. [ PUBMED] [Full text] |
| 11. | Sarvajnamurthy S, Suryanarayan S, Budamakuntala L, Suresh DH. Autologous platelet rich plasma in chronic venous ulcers: Study of 17 cases. J Cutan Aesthet Surg 2013;6:97-9. [ PUBMED] [Full text] |
| 12. | Steenvoorde P, Van Doorn LP, Naves C, Oskam J. Use of autologous platelet-rich fibrin on hard-to-heal wounds. J Wound Care 2008;17:60-3. |
| 13. | O'Connell SM, Impeduglia T, Hessler K, Wang XJ, Carroll RJ, Dardik H. Autologous platelet-rich fibrin matrix as cell therapy in the healing of chronic lower-extremity ulcers. Wound Repair Regen 2008;16:749-56. |
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[Table 1] |
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