Therapeutic efficacy of physical combined therapy in the treatment of venous crural ulcers

Abstract

Objectives

Venous crural ulcer is a serious medical problem indeed, which is connected with patients’ suffering and long term treatment generating high cost. The prognosis is unfavourable in many cases, as complete treatment of ulceration, when it is profound or really extensive is difficult to achieve, and sometimes impossible altogether. The aim of the study was to evaluate the therapeutic efficacy of treatment of venous crural ulcers with the use of multifunctional device LASEROBARIA–S, designed for combined physical therapy procedures.

Method

147 succeeding patients (67 women and 80 men) diagnosed with venous crural ulcer participated in the study, with age varied between 41 and 79 years (average age – 70.2 years). The patients underwent a 60 day cycle of combined physical therapy, with the use of multifunctional device LASEROBARIA–S, during which therapy the lower extremity of the patient was placed in the therapeutic chamber and simultaneously subjected to the action of: local oxygen hyperbaria, low-frequency variable magnetic field and low energy light radiation emitted by semiconductor LED diodes. Prior to the therapeutic cycle and after its completion, planimetric measurements of the area of ulcer and the assessment of pain intensity with use of VAS scale were performed, in relation to selected factors potentially affecting therapeutic effects of applied therapy, as: sex and age of patients, as well as initial size of the ulcer and duration of the ulcer presence.

Results

After the completion of therapeutic cycle, statistically significant reduction of the area of treated ulcer was found, by 5.4 cm² on the average (16.3 cm² vs 10.5 cm²) (p < 0.05). Moreover, as a result of the combined therapy procedures performed, the statistically significant lowering of the intensity of pain sensation experienced by patients, assessed by means of VAS scale, was obtained (2.55 points vs 0.48 points) (p < 0.05). The obtained improvement was not dependent statistically significantly on any of analysed selected factors potentially affecting regenerative and analgesic effect of applied therapy.

Conclusions

The application of combined physical therapy with the use of LASEROBARIA–S device results in significant reduction of the area of the venous crural ulcer surface, as well as reduction of the intensity of accompanying pain complaints and this therapeutic effect was not dependent on sex and age of patients, as well as initial size of the ulcer and duration of the ulcer presence.

Keywords

Venous crural ulcers treatment combined physical therapy LASEROBARIA–S planimetry pain intensity

Introduction

Chronic venous diseases are among the most frequently occurring problems encountered in health care systems in developed and developing countries. The results of treatment of those diseases remain unsatisfactory, despite the contemporary possibilities of diagnostics and treatment. Diseases affecting venous system initially concern minor lesions being reticular veins and spider veins (telangiectasias), which do not significantly affect the life quality of patients. In case of venous ulcer occurrence, when the treatment is not properly selected and applied the prognosis is unfavourable and the disease may lead to serious disability of patients.¹,²

Venous crural ulcers occur in ca. 0.3% of adult population in Western Europe, 2–3 times more frequently in women than in men, the frequency of their occurrence appears to evidently increase with time. Active venous ulcers and healed ulcer scars occur in the total of about 1% of the population.³ Ulceration occurs most frequently in patients with venous insufficiency that has been developing for a longer time, in which disturbances of venous circulation in lower limbs occur, being related to venous valves lesions. That, in turn, results in haemostasis and increased pressure in venous vessels. As a consequence of steadily increasing trophic lesions a necrotic zone gets formed, the final effect of that process is an open wound – crural ulcer. Skin defect occurs most frequently as a consequence of a minor trauma in that area, or spontaneously, without obvious reason. Untreated wounds may lead to very serious complications, which are chronic venous crural ulcers, eventually, in case of unsatisfactory results of treatment they may lead sometimes to the necessity of limb amputation.⁴,⁵

Treatment of vascular diseases, including also chronic wounds (ulcers) with venous aetiology comprises preventive measures (physical activity, proper nutrition, abstaining from stimulants), pharmacotherapy, physiotherapeutic procedures, and surgical treatment as last resort. For many years, the therapy of chronic wounds is carried out in accordance with the recommendations of the International Advisory Board and Polish Association of Wound Treatment, applying the system abbreviated as TIME (tissue debridement, infection control, moisture balance, epidermisation). In accordance with the latest guidelines, the modern approach to treatment of vascular diseases should take into account also physical medicine procedures, which are a precious supplement of the treatment conducted.¹,⁶ Contemporary physical medicine has been steadily extending its therapeutic capacity by introducing innovative devices to clinical practice, which assists in the wound healing processes, including also those for chronic wounds. Preventive and therapeutic application of selected physical factors in the form of both mono- and combined therapy (consisting of simultaneous application of several physical agents to the lesion) has the purpose of preventing lesions (traumas), limitations of activities and detriments for participation in social life, as well as maintenance and optimization of current health condition in patients. The implementation of selected physical medicine procedures (e.g. compression therapy, topical hyperbaric oxygen therapy, therapy with the use of low energy light, low energy laser therapy, magnetotherapy, high voltage electrical stimulation, extracorporeal schock wave therapy, etc.) in early stages of wound development results in activation of physical, chemical, and cellular processes in affected tissues, which in many cases lead to complete healing.^7–11

Aim of the study

The aim of the study was to assess the efficacy of venous crural ulcers treatment with the use of multifunctional device LASEROBARIA–S applied for physical procedures in the form of combined therapy including simultaneous action of local oxygen hyperbaria, low-frequency variable magnetic field and low energy light.

Material and methods

147 succeeding patients (67 women and 80 men), in age range 41 to 79 years (average age: 70.2 years) hospitalized in the Department of Internal Medicine, Angiology and Physical Medicine of Medical University of Silesia in Katowice (Poland) between March 2017 and September 2019 due to non-healing venous crural ulcers caused by chronic venous insufficiency, located on one of the lower limbs, without exclusion criteria, participated in the clinical trial. The subsistence time of the non-healed ulcers was between 6 months and 10 years (5.7 years on the average).

Before the enrolment to the study particular patients during previous hospitalizations and ambulatory care used various pharmacological treatment permitted in the therapy of crural ulcers, including among others: anticoagulants (enoksaparin, warfarin, rivaroxaban, sulodexide, acetylsalicylic acid), phlebotropic drugs (diosmin, micronized purified flavonoid fraction), systemic antibiotics (ciprofloxacin, amikacin), local antibiotics (neomycin in aerosol), topical agents: ointments and creams promoting ulcer healing and exhibiting antibacterial effect (sulphathiazole silver, allantoin, dexpanthenol), hemorrheologic agent (pentoxifylline), various types of wound dressings: hydrogel dressings, hydrocolloid dressings and nano silver dressings, as well as compression therapy with the use of compression bandaging and compression stockings – the compression was used previously by 98 patients (66.67%), among them 84 patients (57.14%) used it just before the beginning of the study. In spite of the applied treatment 72 patients (48.98%) had recalcitrant venous leg ulcers.

All ulcers were stable for several weeks before the enrolling patients for the trial, with symptoms of chronic imflammatory stage, without distinct tendency for healing.

In patients qualified for the trial, their case history was taken and clinical examination was performed (including Doppler USG concerning blood flow in lower limb vessels), in order to establish the exclusion criteria for the study (arterial hypertension, obesity/overweight, generalized infections, polyneuropathy, obliterative inflammation of arteries, postphlebitis syndrome, atherosclerosis, diabetes type 1 and 2, peripheral arteries disease, excessive consumption of alcohol and nicotine addiction, as well as confirmed contraindications for application of procedures with the use of hyperbaric oxygen, low energy light radiation, and low-frequency variable magnetic field).

Basing on the results of Doppler USG of veins 85 patients (57.82%) were diagnosed with the superficial or deep vein insufficiency, 30 patients (20.41%) with the perforator incompetence and 32 patients (21.77%) with the presence of axial reflux.

During the study in all qualified patients independently of the routine pharmacological treatment including for each patient: sulodexide, micronized purified flavonoid fraction, pentoxifylline and acetylsalicylic acid in standard doses and topical therapeutic procedures (compression bandaging and hydrofiber dressings) also procedures of combined physical therapy were executed, with the use of LASEROBARIA–S device (Figure 1).¹²

Figure 1.

Multifunctional therapeutic device LASEROBARIA–S (Inventmed Sp. z o.o., Świętochłowice, Poland) designed for performing combined physical therapy procedures.

Methodology of therapeutic procedures

During the physical procedures the patient’s lower limb with venous crural ulcer, after placing it in a cylindrical therapeutic chamber (closed by means of a flexible sealing flange) was exposed simultaneously to oxygen hyperbaria, using oxygen pressure of 1 mBa (2 kPa), oxygen flow of about 5 l per minute, and oxygen concentration inside the chamber was ca. 90%. Additionally, in the course of the procedure the limb was exposed to variable magnetic field with sinusoidal impulse waveform, frequency of 40 Hz and magnetic induction of 10 mT generated by induction coil located in the housing of the therapeutic chamber, as well as low energy light emitted by semiconductor LED diodes installed in the internal surface of housing of the therapeutic chamber – in the first half of the procedure light wavelength was 635 nm (red range) and in the second half of the procedure the wavelength was 410 nm (ultraviolet range), while the energy density was 10 J/cm² during whole procedure (Figure 2).

Figure 2.

The procedure of combined physical therapy with the use of device LASEROBARIA–S.

Each time after the procedure the therapeutic chamber and the sealing flange were disinfected using Desam OX preparation.

In all patients, a therapeutic cycle consisting of 60 procedures lasting 30 minutes each were performed once a day before noon, in four series consisted of 15 daily procedures applied for 5 weekdays, with a break on Saturdays and Sundays. The intervals between subsequent series of procedures lasted 4 weeks.

During the study no additional dermatological treatment was applied which is a standard in such case, except of topical interventions having the aim of wound debridement, as well as dressings that provide proper moisture and sterility of the ulceration. During the study, patients continued the pain control treatment applied so far.

After completion of each procedure in order to provide antisepsis and mechanical protection, the ulcer surface was provided with antiseptic hydrofiber dressing Aquacel Ag Extra (ConvaTec, Reading, Berkshire, Great Britain) composed of sodium carboxymethylcellulose fibers with 1.2% ionic silver, which enabled antibacterial effect and enhanced purification of the ulcer, and subsequent compression bandaging with the use of Codoban bandage (Tricomed, Łódź, Poland) (compression class 3) was applied for 7 hours daily on leg in between the combined physical therapy procedures.

Before and after the end of complete treatment cycle, in order to verify the obtained healing results, planimetric assessment of ulcer surface area was performed, with the use of a computer program designed by Michał Senejko, MSc.

Planimetric assessment of lesions area using the computer program was performed in manual mode. In the first stage, the doctor downloaded the analysed picture from a digital photo of a pressure ulcer, with a subsequent selection of lesions’ contours. The program allowed the selection of areas of lesions in two modes. In the first mode, the analyst moved the mouse cursor continuously along the contour of target area. After double-clicking the mouse cursor, the drawn contour was automatically closed, creating a closed curve. In the second mode a selected contour was defined by indicating a set of points of lesion’s contour. In this mode, the program automatically connected the new point searched with previous points, as a result of which one got a closed contour.

When the selection stage was completed, the program automatically calculated the surface area within the previously defined contour. Surface area was represented in pixels or, after performing adequate calculation, in square centimetres. In order to represent the surface area in square centimetres, it was necessary to calibrate the distance of analysed leg from camera lens. To do this, during shooting, the leg was marked with a green square of 1x1 cm². Thanks to this, the program can localize the afore mentioned green square and calculate its size, and therefore, by performing the scaling, it was able to assess the magnitude of venous ulcer.

Before starting the therapeutic cycle and after its completion also a subjective assessment of pain sensation intensity has been made by patients, by means of a modified questionnaire for pain assessment, acc. to VAS scale.

The measurements of ulcer surface area and pain intensity were performed in relation to selected factors potentially affecting therapeutic effects of applied therapy, as: sex and age of patients, as well as initial size of the ulcer and duration of the ulcer presence.

The study was conducted in accordance with the Declaration of Helsinki (1964) and its protocol was approved by the Local Bioethical Commission of the Medical University of Silesia in Katowice, Poland (permission no.: KNW/0022/KB1/102/16). All qualified patients signed a written consent for participation in this study.

Statistical analysis

Statistica 7.0 software has been used to provide statistical analysis of the results obtained. Kolmogorov-Smirnov test has been used for assessing the distribution of study data, data of normal distribution have been presented as mean value ± standard deviation (SD). For the purpose of assessing the statistical significance of differences in parameters examined, before and after treatment, the Wilcoxon test for matched pairs has been applied. The value of p < 0.05 has been assumed as threshold value for statistical significance of differences analysed.

Results

The results of the measurements of venous crural ulcers surface area before starting the therapeutic cycle and after its completion are presented in Figure 3. After the execution of the cycle of 60 combined physical therapy procedures with the use of LASEROBARIA–S device, a statistically significant reduction of the ulcer surface area, from the average of 16.3±10.1 cm² to the average of 10.5±8.1 cm² was obtained (p < 0.05).

Figure 3.

Comparison of the area of venous crural ulcers surface (mean value ± SD), assessed by planimetric method, before starting the cycle of combined physical therapy and after its completion.

The results of the measurements of venous crural ulcers surface area before starting the therapeutic cycle and after its completion in relation to sex and age of patients, as well as initial size of the ulcer and duration of the ulcer presence are presented in Table 1.

Table 1.

Comparison of the area of venous crural ulcers surface (mean value ± SD), assessed by planimetric method, before starting the cycle of combined physical therapy and after its completion in relation to sex and age of patients, as well as initial size of the ulcer and duration of the ulcer presence, with statistical evaluation.

Factors potentially affecting obtained regenerative effect			Ulcer surface area before treatment [cm²] (mean ± SD)	Ulcer surface area after treatment [cm²] (mean ± SD)	p
Initial size of the ulcer	<10 cm²	n = 46	6.45±2.13	2.98±1.85	<0.001
Initial size of the ulcer	>10 cm²	n = 101	20.81±9.12	14.41±6.78	<0.001
p			<0.001	<0.001
Duration of the ulcer presence	<5 years	n = 63	9.26±4.28	4.74±4.12	<0.001
Duration of the ulcer presence	>5 years	n = 84	21.60±10.07	14.86±7.68	<0.001
p			<0.001	<0.001
Age	<55 years	n = 18	20.35±13.46	12.67±10.48	<0.001
Age	>55 years	n = 129	15.75±9.53	10.22±7.74	<0.001
p			0.183	0.423
Sex	Women	n = 67	17.39±9.79	11.49±7.75	<0.001
Sex	Men	n = 80	15.40±10.41	9.71±8.39	<0.001
p			0.067	0.089

Before the beginning of the therapeutic cycle, as well as after its completion average values of the ulcer surface area in subgroups with regard to sex and age did not differ significantly, while in subgroups of patients with initial size of the ulcer >10 cm² and duration of the ulcer presence >5 years average values of the ulcer surface area were statistically significantly higher as compared to subgroups of patients with initial size of the ulcer < 10 cm² and duration of the ulcer presence < 5 years, respectively, both before the beginning of the therapeutic cycle and after its completion. In all subgroups of patients with regard to sex, age, initial size of the ulcer and duration of the ulcer presence as a result of combined physical therapy a statistically significant reductions of average values of the ulcer surface area were obtained (p < 0.001). Though in subgroups of men, as well as patients in age < 55 years, with initial size of the ulcer < 10 cm² and duration of the ulcer presence < 5 years an average values of percentage reductions of the ulcer surface area in relation to initial values were bigger as compared to women, as well as patients in age >55 years, with initial size of the ulcer >10 cm² and duration of the ulcer presence >5 years, (36.95% vs 33.93%, 37.74% vs 35.11%, 53.80% vs 30.75% and 48.81% vs 31.20%, respectively), the observed differences were not statistically significant.

In the course of treatment, one could observe systematic reduction of the amount of purulent deposit on the surface of ulceration being subject of treatment. The secretion was changing into a serous one, and its putrid smell gradually disappeared. Subsequently, fine grain granulation tissue developed. After a few more procedures, epidermis developed on the peripheries of the ulcer. At the same time, improved skin trophicity has been observed in all patients, and the skin pigmentation was restored.

The complete ulcer healing rate was 43,54% (64 of 147 ulcers) – 17 ulcers (11.57%) were completely healed during the study and next 47 ulcers (31.97%) were completely healed at the end of the therapeutic cycle.

The results of subjective assessment of pain sensations accompanying the ulceration, made by patients before the start of therapeutic cycle and after its completion are presented in Figure 4. After completion of the cycle of 60 combined physical therapy procedures with the use of LASEROBARIA–S device, the patients reported statistically significant reduction of pain sensations, from the average of 2.55±0.6 points to the average of 0.48±0.5 points in VAS scale (p < 0.05).

Figure 4.

The results of the measurements of the intensity of pain sensations (mean value ± SD) assessed subjectively by subjects by means of VAS scale, before starting the combined physical therapy cycle and after its completion, in relation to sex and age of patients, as well as initial size of the ulcer and duration of the ulcer presence, with statistical evaluation are presented in Table 2.

Table 2.

Comparison of the intensity of pain sensations (mean value ± SD) assessed subjectively by subjects by means of VAS scale, before starting the combined physical therapy cycle and after its completion, in relation to sex and age of patients, as well as initial size of the ulcer and duration of the ulcer presence, with statistical evaluation.

Factors potentially affecting obtained analgesic effect			VAS score before treatment [points] (mean ± SD)	VAS score after treatment [points] (mean ± SD)	p
Initial size of the ulcer	<10cm²	n = 46	2.56 ± 0.65	0.56 ± 0.53	<0.001
Initial size of the ulcer	>10cm²	n = 101	2.55 ± 0.63	0.45 ± 0.52	<0.001
p			0.944	0.219
Duration of the ulcer presence	<5 years	n = 63	2.60 ± 0.66	0.47 ± 0.52	<0.001
Duration of the ulcer presence	>5 years	n = 84	2.52 ± 0.63	0.51 ± 0.53	<0.001
p			0.469	0.776
Age	<55 years	n = 18	2.61 ± 0.69	0.55 ± 0.51	<0.001
Age	>55 years	n = 129	2.55 ± 0.63	0.48 ± 0.53	<0.001
p			0.753	0.553
Sex	Women	n = 67	2.56 ± 0.63	0.47 ± 0.50	<0.001
Sex	Men	n = 80	2.55 ± 0.65	0.50 ± 0.52	<0.001
p			0.802	0.788

Before the beginning of the therapeutic cycle, as well as after its completion average values of the VAS score in particular subgroups of patients with regard to sex, age, initial size of the ulcer and duration of the ulcer presence did not differ statistically significantly. In all subgroups with regard to those factors as a result of combined physical therapy a statistically significant decrease in average values of the VAS score was obtained (p < 0.001). Though in subgroups of women, as well as patients in age >55 years, with initial size of the ulcer >10 cm² and duration of the ulcer presence < 5 years an average percentage decreases in values of the VAS score in relation to initial values were slightly bigger as compared to men, as well as patients in age < 55 years, with initial size of the ulcer < 10 cm² and duration of the ulcer presence >5 years, (81.64% vs 80.39%, 81.18% vs 78.93%, 82.35% vs 78.12% and 81.92% vs 79.76%, respectively), the observed differences were not statistically significant.

In most subjects, alleviation of pain sensation was the earliest, subjectively experienced result of the conducted therapy.

Discussion

Venous crural ulcers still pose an enormous problem for treatment and therapy economics, due to the ever increasing occurrence of that morbid state and its chronic character. Despite significant progress in discovering the patho-physiological processes influencing wound healing, the results of chronic wound treatment, including the treatment of venous crural ulcers of various pathological background are still unsatisfactory. The efficacy of pharmacological treatment varies, depending on the aetiology of the lesions, yet in most of the cases it fails to bring the expected treatment results despite lengthy course of therapy. Additionally, the predisposition to recurrence of ulcers results in frequent hospitalizations and prolonged provision of care. The patients, besides physical suffering caused by pain also suffer psychologically and mentally, are often depressed, do not maintain social contacts, which compromises their quality of life. Moreover, local tissue defects with extensive necrosis accompanying them, may result in numerous serious life threatening complications, causing significantly negative impact upon the entire patient’s life in the future. Absence of effective treatment for venous crural ulcer may, in consequence, lead sometimes to the necessity of performing limb amputation.¹³,¹⁴

In planning the complex treatment of chronic venous crural ulcers, a multi-directional model of therapeutic management should be followed. The ulcers that develop (regardless their aetiology), in the exudative phase require debridement the wound of necrotic tissues and purulent secretion, whereas in the period of granulation and epidermisation it is necessary to stimulate the latter processes.¹⁵ In order to meet the above objectives in conservative treatment, besides the standard topical procedures, it is necessary to apply modern methods of physical medicine, whose biological action is related, among others, to stimulating the regeneration and repair processes.¹,¹⁶

The results of 5-month lasting treatment, reported in the study presented here, obtained by means of a multifunctional device designed for conducting combined physical therapy demonstrated evident improvement as regards healing of distal lower limb ulcers, manifested in statistically significant reduction of ulcer surface area, assessed by objective planimetric method. The effect was, most probably, caused by the synergistic therapeutic effect of three various physical stimuli: hyperbaric oxygen, low frequency variable magnetic field, as well as low energy light radiation emitted by semiconductor LED diodes. The synergistic effect of simultaneous action of physical procedures with properly selected configuration of physical parameters was related among other to improved nutrition, oxygenation, and blood supply to tissues, as well as intensification of epidermisation process, which jointly was conducive to substantial acceleration and enhancement of healing efficiency regarding the ulcers treated. It is worthy stressing that in case of several patients the applied combined physical therapy procedures resulted in complete healing of the ulcers.

Confirmation of the efficacy of physical medicine procedures in complex treatment of chronic wounds can be found in the results of study by Thackham et al., in which the application of hyperbaric oxygen therapy is reported to accelerate the wound healing process through improved blood circulation in tissues surrounding the area of ulceration, and stimulation of tissue regeneration processes. According to the authors, the basis for the therapeutic effect observed has been the occurrence of microcirculation stimulation induced by hyperbaric oxygen, leading to restoration of the damaged vascular rete, as well as increase of local blood supply, enhanced rheological properties of blood, as well as stimulation for collage production by fibroblasts.¹⁷

In another study, Hunter et al. demonstrated that adding the procedures of hyperbaric oxygen therapy to the programme of complex therapy of distal leg ulcers in the course of diabetic foot syndrome, as a result of improved blood supply and tissue nutrition, as well as increased pressure of the oxygen provided to the tissues is advantageous for stimulating the processes of regeneration and intensifying epidermisation processes, as a result leading to shortening the ulceration healing time and enhancing life quality of treated patients.¹⁸

In turn, Kalani et al. as well as Strauss have proven that in patients with leg ulcers in the course of diabetic foot syndrome, the application of hyperbaric oxygen therapy at a proper time, with properly selected physical parameters, improves the efficacy of complex treatment. Having in mind the minimum range of contraindications for application, hyperbaric oxygen therapy may constitute a useful element in the complex programme of management of those patients.¹⁹,²⁰

On the other hand, the case-based study of Pasek et al., has confirmed the therapeutic efficacy of joint effect of light radiation emitted by LEDs and variable magnetic field in the treatment of venous crural ulcer in a 76-year old patient, for whom the 5 years of classical pharmacological treatment failed to give satisfactory effects. The application of magneto-LED-therapy resulted in a dynamic change in the progress of ulcer healing, connected with increased pain sensation threshold, enhanced skin pigmentation, and filling skin defects with granulation tissue, and in consequence of the conducted combined therapy after 4 weeks the ulcer healed completely.²¹

The results of the discussed study also demonstrated a systematic reduction of pain sensations accompanying ulcers, which was the first benefit of the therapy applied, objectively noted by the patients.

Beneficial therapeutic effect related to significant reduction of pain intensity, as well as a twice faster reduction of the dimensions of ulceration treated and increase of the relative granulation area, in relation to the initial values were also obtained by Taradaj et al. in patients with skin ulcers secondary to venous circulation disorders, for whom selected physical procedures have been added to classical pharmacotherapy.²²

The study by Sieroń et al. confirmed, in patients with venous crural ulcers treated by magnetostimulation procedures with the use of low induction variable magnetic field, the occurrence of significantly faster reduction of surface area and volume of ulcer, as well as increase of the granulation area formed, in comparison with the initial values. They have been assessed by objective method of planimetry; the procedures applied led to complete healing of the ulceration in many cases, they also resulted in evident reduction of inflammatory process intensity in the tissues surrounding the ulceration, and subsiding the accompanying pain sensations.²³,²⁴

The limitation of this study is lack of follow-up observation.

Summary

The search for various strategies in therapeutic management, which can improve the efficacy of treatment of chronic venous crural ulcers presently poses a substantial clinical challenge and requires vast knowledge and skilful planning of the treatment at various stages of that ailment’s development. Unfortunately, social awareness is still insufficient in that respect. Often patients come for treatment too late, when complicated ulcers have already developed, accompanied by destruction of tissues located in deeper structures, and secondary neurological disturbances. In such advanced cases, much hope is put in the application of novel combined physical therapy methods, within the scope of complex clinical management, in particular those designed using modern technological solutions, which enable simultaneous application of various physical agents by means of a single device.

Conclusions

The procedures of combined physical therapy with the use of LASEROBARIA–S device enabling simultaneous exposure of lower limb to hyperbaric oxygen, low-frequency variable magnetic field and low energy light radiation result in statistically significant reduction of the surface area of venous crural ulcers, assessed by objective planimetry, as well as in reduction of the intensity of accompanying pain sensations and this therapeutic effect was not dependent on sex and age of patients, as well as initial size of the ulcer and duration of the ulcer presence.

Due to the high therapeutic efficacy and safety of application, such procedures may constitute a useful element of complex therapeutic management of patients with venous crural ulcers.

Footnotes

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

Ethical approval

Guarantor

Jarosław Pasek - JP

Contributorship

JP – study design, data collection, data interpretation, manuscript preparation, literature search

SSz – study design, data collection, manuscript preparation, literature search, statistical analysis

GC – study design, data collection, data interpretation

ORCID iD

Jarosław Pasek

References

Santler

George

Chronic venous insufficiency – a review of pathophysiology, diagnosis, and treatment.

J Dtsch Dermatol Ges 2017; 15: 538–556.

Barstow

Kassop

Cardiovascular disease: chronic venous insufficiency and varicose veins.

FP Essent 2019; 479: 16–20.

Callejas

Manasanch

Epidemiology of chronic venous insufficiency of the lower limbs in the primary care setting. Int Angiol 2004; 2: 154–163.

Negus

(ed) Crural ulceration – diagnostics and treatment. Bielsko-Biała: α-Medica Press, 2006.

Abelyan

Abrahamyan

Yenokyan

A case-control study of risk factors of chronic venous ulceration in patients with varicose veins.

Phlebology 2018; 33: 60–67.

Stucker

Altmeyer

Reich-Schupke

Therapy of venous leg ulcers. New and established approaches. Hautarzt 2011; 62: 504–508.

Geerts

Bergqvist

Pineo

, et al. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133: 381–453.

Pasek

Cieślar

Stanek

, et al. Health resort treatment – new possibility in vessels treatment? Acta Angiol 2010; 16: 99–113.

Dymarek

Halski

Ptaszkowski

, et al. Extracorporeal shock wave therapy as an adjunct wound treatment: a systematic review of the literature. Ostomy Wound Manage 2014; 60: 26–39.

10.

Taradaj

Franek

Cierpka

, et al. Early and long-term results of physical methods in the treatment of venous leg ulcers: randomized controlled trial. Phlebology 2011; 26: 237–245.

11.

Pasek

Cieślar

Sieroń

Combined therapy in the treatment of mixed etiology leg ulcer – case report.

Ther Clin Risk Manag 2018; 14: 1915–1921.

12.

Sieroń

Pasek

LASEROBARIA–S new apparatus for physical treatment of wounds. Pract Rehabil 2016; 4: 68.

13.

Mallick

Raju

Campbell

, et al. Treatment patterns and outcomes in patients with varicose veins. Am Health Drug Benefits 2016; 9: 455–465.

14.

Słowiński

Krosny

Raciborski

, et al. The current views on the formation and treatment of venous leg ulcers. Progr Med 2012; 3: 27–34.

15.

Park

Copeland

Henry

, et al. Complex wounds and their management. Surg Clin North Am 2010; 90: 1181–1194.

16.

Pasek

Cieślar

Motow-Czyż

, et al. The selected physical methods in ambulatory treatment. Pract Rehabil 2018; 5: 68–73.

17.

Thackham

McElwain

Long

RJ.

The use of hyperbaric oxygen therapy to treat chronic wounds: a review.

Wound Repair Regen 2008; 16: 321–330.

18.

Hunter

Langemo

Anderson

, et al. Hyperbaric oxygen therapy for chronic wounds. Adv Skin Wound Care 2010; 23: 116–119.

19.

Kalani

Jorneskog

Naderi

, et al. Hyperbaric oxygen (HBO) therapy in treatment of diabetic foot ulcers. Long-term follow-up. J Diabetes Complicat 2002; 16: 153–158.

20.

Strauss

MB.

Hyperbaric oxygen as an intervention for managing wound hypoxia: its role and usefulness in diabetic foot wounds.

Foot Ankle Int 2005; 26: 15–18.

21.

Pasek

Mucha

Sieroń

Ulcera crurum: treatment with low frequency magnetic field stimulation with high energy LEDs. Description of case. Acta Bio–Opt Inform Med 2006; 1: 15–19.

22.

Taradaj

Franek

Dolibog

, et al. The treatment of hard healing wounds. Pract Rehabil 2008; 1: 34–35.

23.

Sieroń

Franek

Brzezińska-Wcisło

, et al. Attempt to objective estimation of therapeutic efficacy of magnetostimulation in the treatment of venous leg ulcers. Balneol Pol 2005; 1–2: 16–22.

24.

Pasek

Sieroń

Magnetostimulation in the treatment of crural vein ulceration. Int Wound J 2012; 10: 1742–1748.