الفهرس 
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Abstract
Chronic leg ulcers are defined as wounds located below the knee that do not heal within a 6-week period. The most common form of chronic leg ulcers is the venous leg ulcer (VLU). It accounts for approximately 75% of all chronic leg ulcers, and are characterized by several factors that hinder and delay healing.
VUs develop in the context of advanced chronic venous insufficiency (CVI) with dysfunction of the calf muscle pump. The venous hypertension caused by venous valve incompetence is the key to ulcer development.
Nevertheless, the exact mechanism whereby venous hypertension leads to VUs is unknown. Recent studies suggest that the pathogenesis of the ulceration process is associated with the abnormal changes in microcirculation and consequent inflammatory response inherent to CVI.
First-line conventional treatment of vascular ulcers is mostly directed to leg elevation, compression, and wound care while topical steroids, aspirin, and surgery are considered as second-line therapies. However, these approaches do not constantly attain sufficient healing of these ulcers. A variety of different treatments are, hence, being investigated as bioengineered tissue, maggot therapy, and hyperbaric oxygen
therapy.
Platelet rich plasma (PRP) is a product derived from blood that is increasingly being widely used in clinical practice and, among other applications, has become an alternative approach to the dressings used to date for the treatment of chronic ulcers.
The curative properties of PRP rely on the fact that platelets are a physiological reservoir of growth factors, which have an active role in tissue regeneration. It is well known that platelets contain a great variety of growth factors, with healing functions. They are safe, simple, affordable and a less expensive procedure in the treatment of chronic ulcers with reportedly good results.
However, there are no clear gold standard protocols for PRP generation, and there are some limitations such as the poor characterization of the obtained products and the lack of regulation and standardization.
The study is aimed to evaluate the efficacy of platelet rich plasma upon the healing of active venous ulcers in patients with chronic venous leg ulcers. This is prospective randomized comparative study, was conducted in Ain shams university hospitals & Mataria teaching hospital on 20 patients divided into two groups: The first group (the first study group); included 10 patients managed by compression therapy plus PRP injection, our endpoint of this study was be healing of the ulcer, The second group (control group) included 10 patients managed by compression therapy only.
The main results of the study revealed that:
Regarding demographic data, males were more prevalent in both groups; where there were 6(60.0%) males in study group and 7(70.0%) males in the control group.
The age of the patients ranged from 26 to 60 years, with median of 37.5 and Mean ± SD. 40.20 ± 10.71 years in the study group, and ranged from 25 to 48 years, with median of 37.5 and Mean ± SD. 36.60 ±6.42 years in the control group.
there was no statistically significant difference between the two groups as regards age and gender.
There were comorbidities in the patients of each group, where in the study group 6(60.0 %) were positive smoking, 5(50.0%) had hypertension, 1(10.0%) had diabetes, 1(10.0%) had Congestive heart diseases, 5(50.0%) had history of recurrent venous ulcers, and 7(70.0%) had recent DVT, and in the control group 5(50.0%) were positive smoking, 3(30.0%) had hypertension, 1(10.0%) had diabetes, 0(00.0 %) had Congestive heart diseases, 6(60.0
%) had history of recurrent venous ulcers, and 5(50.0%) had recent DVT.
The BMI of the patients ranged from 20 to 37 years, with median of 30 and Mean ± SD. 28.62 ± 5.32 in the study group, and ranged from 20 to 35.5 years, with median of 31 and Mean ± SD. 27.73 ±5.22 in the control group.
The Ankle Brachial Index ranged from 0.80 to 1.20, with median of 1.0 and Mean ± SD. 1.02 ± 0.131 in the study group, and ranged from 0.80 to 1.20, with median of 1.05 and Mean ± SD. 51.0± 0.134in the control group.
The comparison between the two groups showed that there was no statistically significant difference between the two groups as regards comorbidities.
all the 20 (100%) patients had active venous leg ulcer (C6). Ulcers were associated with: Varicose veins (C2) in 8 (40%) patients, edema (C3) in 16 (80%) patients, pigmentation (C4a) in 17 (%88) patients and lipodermatosclerosis (C4b) in 16 (80%) patients.
Regarding the characteristics of the ulcer; in study group the ulcer was in the right leg in 6(60%) of patients, left in 4(40%), and medial in 7(70%), lateral in 3(30%), and as regards the number of ulcers there was only one ulcer in 8(80%) patients, two ulcers in 2(20%) patients, in control group the ulcer was in the right leg in 8(80%) of patients, left in 2(20%), and medial in 7(70%), lateral in 3(30%), and as regards the number of ulcers there was only one ulcer in 10(100%) patients.
The size of the ulcers ranged from 5.0 to 9.2 cm2, with median of 7.8 and Mean ± SD. 7.55 ±1.32 cm2 in the study group, and ranged from 33 to 60 cm2, with median of 48.5
and Mean ± SD. 47.50 ±9.27cm2 in the control group.
The duration of the ulcers ranged from 6months to 17 years, with median of 2.75years and Mean ± SD. 6.04± 5.79 years in the study group, and ranged from four months to 15 years, with median of 2.5 years and Mean ± SD. 4.10± 4.72 years in the control group.
Fourteen (70%) of patients had been treated by other methods which included conventional compression in 11(55%) of them, 7in study group and 4 in control group, GSV stripping in only 2(10%) patients; one in each group and one (5%) patient underwent previously failed skin grafting of the ulcer in the study group.
there was no statistically significant difference between the two groups as regards characteristics of the ulcer.
there was no statistically significant difference between the two groups as regards lab data and almost all patients’ lab data were within normal.
In study group one patient (10%) had isolated superficial venous incompetence, 2 patients (20%) with incompetent perforators only, 3 patients (30%) had incompetent deep venous system only and 4 patients presented with incompetent more than one system. Three of them (10%) was presented with incompetent superficial venous system associated with incompetent perforators and one patients (10%) were presented with incompetent superficial venous system associated with incompetent deep venous system, in
control group 3 patient (30%) had isolated superficial venous incompetence, 1patient (10%) with incompetent perforators only, 2 patients (20%) had incompetent deep venous system only and 3 patients presented with incompetent more than one system. Two of them (20%) was presented with incompetent superficial venous system associated with incompetent perforators, and one patient (10%) presented with incompetent both deep venous system and perforators. While there was only 1 patient (10%) with competent both superficial and deep system .
As regards deep system patency ,it was patent in 6(60%) patients in study group, and in 3(30%) patients in control group.
the basal size of the ulcer was almost equal in the two groups with no statistically significant difference, after treatment, there was statistically significant decrease in ulcer size in the study group than the control group every follow up period after one and four weeks and three and six months, and we found that after three months all cases of the study group had completed heal, where the control groups completed heal in the sixth month.
Also in the study group there was statistically significant decrease in the ulcer size from the first week till the end of the follow up period, where in control group the decrease began to be statistically significant from the fourth week.
as regards change in Ulcer size after treatment we found that after one and four weeks the change was statistically significant higher in the study group than the controls, then after 3 months there was no statistically significant difference between the two groups, and 6months after treatment the change was statistically significant higher in the control group than the study group where the study group were all healed but the controls were still completing their healing.
Based on our results we recommend for further studies on larger patients and longer period of follow up to confirm our study.
Conclusion
CONCLUSION
Chronic venous leg ulcers come with cost and morbidity for patients and society also. PRP is a safe, simple, inexpensive and biocompatible procedure. In our study, PRP is found to be useful in enhancing the wound healing in chronic venous leg ulcers without any adverse events. Since, there is no standardization of the procedure, more randomized control studies are needed to make a standard protocol for the preparation of PRP.
Recommendation
RECOMMENDATIONS
Further studies on large geographical scale and on larger sample size to emphasize our conclusion.
More patients, longer follow-up, and multicenter experience are all necessary to accurately figure out the efficacy of platelet rich plasma in patients with chronic venous leg ulcers.
Some measures may be planned to identify and prevent factors associated with poor healing progn