Magnetostimulation in complex treatment of venous leg ulcers

Introduction

Chronic non-healing wounds pose a significant challenge to public health institutions around the world. This large group of patients consists mainly of patients with leg ulcers of various etiologies, pressure sores, diabetic foot and post-traumatic or post-operative wounds. Doctors of many specialties are responsible for planning the treatment, and until the decision is made to select a therapeutic method, the patient is left with the problem of daily hygiene, care and living with the wound [1, 2].
Despite advances in pharmacotherapy, physical medicine, and materials engineering that support tissue regeneration, the complex micro-environment of chronic wounds, including biofilm formation, chronic inflammation, and impaired blood perfusion, continues to impede the progress of treatment of chronic wounds, including venous leg ulcers (VLUs). Appropriate assessment of the patient’s clinical condition and initiation of early therapeutic interventions are essential because they can increase cure rates by preventing wound deterioration, complications and recurrences, reduce health care costs in these patients by shortening hospital stays and minimizing resource use, and improving quality of patients’ lives by relieving pain and accelerating the return to full fitness [1, 3]. According to He et al., determining intervention measures to prevent VLU recurrence should play a key role in the therapy process. The most frequently recommended strategies to prevent VLU occurrence and recurrence include lifelong high-pressure compression therapy, exercise therapy, and health education. Moreover, the participation of multidisciplinary teams in the care of patients with VLU is of key importance, and the composition of the team collaborating in the diagnosis, treatment and care of wounds should be modified depending on their type and etiology [4].
According to the current data, chronic wounds affect 2–6% of the population worldwide. Currently, up to 4% of total health care expenditure concerns the costs incurred in connection with the treatment of difficult-to-heal wounds [5]. In Poland, according to statistical data, the problem of wound treatment, including chronic wounds, affects over 650,000 people, and the costs spent on their treatment amount to almost PLN 3 billion annually. There is also an increasing trend in the frequency of their occurrence. This is related to the demographic situation and aging of societies, as well as the increased incidence of lifestyle diseases such as diabetes, hypertension, obesity and hypercholesterolemia, which favor the development of chronic wounds [1].
It is worth emphasizing that approximately 90% of chronic wounds are treated on an outpatient basis or at home. Among all patients with chronic wounds, as many as 76% have comorbid chronic diseases, including 46% of patients with diabetes as the most common comorbid disease. This shows how serious this disease is in medicine [1, 6]. Therefore, the search for effective, alternative methods of treating chronic wounds is extremely important. According to the European Wound Management Association, the document entitled Holistic management of wound-related pain states that, in addition to standard pharmacological treatment and specialized dressings, other non-pharmacological methods should also be implemented. These methods have a supportive effect, and their usefulness is emphasized in the absence of satisfactory results from the current treatment or in cases where it is impossible to use it (inability to take specific pharmacological agents for medical reasons, allergy to a specific type of drug, intolerance to a specific medical dressing, etc.). In these situations, alternative methods, including physical treatments may be the methods of choice. The most common include phototherapy treatments, electrical stimulation, the use of a low-frequency alternating magnetic field, negative pressure therapy, combined therapy treatments (magneto-LED therapy, magnetolaserotherapy/magnetolaser therapy), the use of skin matrices and biomaterials, the use of transplantation materials and 3D-printed skin substitutes, hyperbaric oxygen therapy, normobaric therapy or ozone therapy [1, 7, 8].
Due to the complex etiopathogenesis of chronic wounds, the most beneficial therapeutic effects are achieved by a comprehensive, multidirectional treatment model that takes into account the synergistic impact of individual therapeutic methods, including methods in the field of physical medicine. These treatments can often accelerate the healing process and thus shorten the treatment time of patients [7, 8].
Magnetostimulation is a therapy with an alternating magnetic field with low and medium magnetic induction values. The emitted therapeutic signal is characterized by a multi-peak frequency spectrum with precisely defined pulse shapes. The course of the magnetic field is similar to a saw tooth, and the basic impulses of the spectrum with a frequency of 180–190 Hz are arranged in pulse packets with a frequency of 12.5–29 Hz, groups of packets with a frequency of 2.8–7.6 Hz and series with a frequency of 0.08–0.3 Hz, constituting the basis of the ion cyclotron resonance [9].
The beneficial effects of magnetostimulation treatments in wound treatment result primarily from their biological effects, which include, among others: intensification of oxygen utilization and tissue respiration processes, intensification of anaerobic respiration processes in ischemic tissues, anti-inflammatory effects related to the modulation of the profile of secreted cytokines, and vasodilatory and angiogenic effects associated with increased proliferation of endothelial cells and production of fibroblast growth factor. Additionally, these treatments cause the development of collateral circulation in the area of the wounds. It is also important to emphasize the analgesic effect of these treatments in the case of coexisting pain. According to the few scientific publications in the available literature so far, the undoubted advantages of magnetostimulation, in addition to its high therapeutic effectiveness, also include its non-invasiveness, low costs of treatment, lack of significant side effects and undesirable effects, and a small number of contraindications to its use [9, 10].
The aim of the study is to present the results of therapy with the use of magnetostimulation procedures in a 70-year-old female patient with a venous leg ulcer resistant to standard treatment.

Case report

A 70-year-old female patient was urgently referred to the Clinical Department of Internal Diseases, Angiology and Physical Medicine in Bytom of the Medical University of Silesia in Katowice due to an allergic reaction in the form of a massive, confluent rash on the skin of the upper and lower limbs and face accompanied by severe burning and itching, which occurred in the course of treatment of the venous leg ulcer using silver dressings. The patient started using these dressings for a month, because the current treatment of the ulcer on an outpatient basis (for about 6 months), based mainly on the use of ointments, antibiotics and traditional dressings, did not produce fully satisfactory results.
The medical documents showed that the patient was treated for deep vein thrombosis, hypertension, type 2 diabetes and gout. The patient had been smoking cigarettes for over 30 years – she stopped smoking before hospitalization.
On admission, physical examination revealed a draining ulcer with local inflammation of the skin and subcutaneous tissue in the area of the ulcer on the left lower leg (Fig. 1). The patient felt pain in the area of the ulcer with intensity of 7 on the VAS scale.
Additionally, bilateral large Baker’s cysts of the knee joints and obesity were found (Body Mass Index (BMI) was 31 kg/m²).
The patient was admitted to the Department. Laboratory tests revealed hyperglycemia, increased percentage of glycated hemoglobin (6.85%), increased CRP concentration (23.1 g/l) and leukocytosis (16.1 g/l). During hospitalization, antiallergic drugs and targeted antibiotic therapy according to the antibiogram results obtained from the culture of smears from the ulcer was introduced.
Due to the lack of effects, the current outpatient treatment of the leg ulcer and the presence of comorbidities causing an increased risk of disturbances in the proper ulcer healing process, in addition to pharmacological treatment and daily compression therapy, the patient was treated with magnetostimulation procedures.

Procedure of magnetostimulation treatments

Physical procedures were performed with the use a Viofor JPS Standard device (Med and Life, Komorów, Poland). A large ring clinical applicator was used, which as part of the M2P2 therapeutic program (M2 – application with increasing intensity throughout the treatment, P2 – JPS system option with two types of pulses using the ion cyclotron resonance), emitted a variable magnetic field with an intensity of 8 in the 12 gradual scale/on a scale of 0 to 12, which corresponded to an average magnetic field induction value of 250 µT. The treatments were performed without any contact with the ulcer area, once a day for 15 days with breaks on Saturday and Sunday (Fig. 2). During the treatments, which lasted 12 minutes each time, the patient was in a sitting position and both limbs were inside the ring applicator.
After each physical procedure, a sterile dressing was applied to the ulcer to provide antiseptic and mechanical protection. Between physical therapy treatments, the left lower limb was treated with compression therapy using a Codoban bandage (Tricomed, Łódź, Poland) for approximately 10 hours a day (compression class 3).

Results

After the first 5 physical procedures of the therapeutic cycle, the patient reported a significant reduction in the intensity of pain ailments (2 points on the VAS scale). There was also a significant reduction in the intensity of inflammation in the tissues surrounding the ulcer and the amount of purulent secretion, as well as intense granulation of the wound, which contributed to the stimulation of the ulcer healing process. On the 10^th day of hospitalization, the patient was discharged home in good general and local condition with the recommendation to continue physical procedures on an outpatient basis. The patient did not report any complications or side effects during the magnetostimulation procedures. The final treatment result after completing the therapeutic cycle including a total of 15 treatments is presented in Figure 3.

Discussion

Leg ulcers resulting from venous diseases are one of the most common problems of the health care system in developing countries. Treatment results are still unsatisfactory despite currently available diagnostic and therapeutic options. If ulcer treatment is ineffective or not fully effective, complications may lead to dangerous health consequences, including many systemic symptoms that threaten the health and life of patients and amputation of limbs [4, 11].
The treatment of leg ulcers should be a multi-stage process with two main directions: conservative treatment and surgical treatment aimed at improving blood flow and increasing tissue oxygenation. The modern model of dealing with chronic lower limb ulcers and the accompanying pain more and more often includes physical medicine treatments (physical therapy) [1, 8, 11]. One of such solutions is treatments using variable magnetic fields, including magnetostimulation. The impact of a variable magnetic field with the physical parameters of magnetostimulation, among many biological effects, causes among others: intensification of the healing processes of chronic wounds. It mainly concerns increasing tissue oxygenation, accelerating the regeneration of ischemic skin fragments and the processes of granulation and epidermization/epithelization of wounds [10, 12, 13].
The search for various solutions that can improve the effectiveness treatment of chronic wounds is currently a major clinical challenge and requires extensive knowledge and skills in treatment planning. In current medical practice, this knowledge is often incomplete or there are limitations resulting from the lack of availability or high costs of appropriate equipment, hence the use of routine therapeutic procedures usually predominates [1–3, 14].
The presented case showed that the timely implementation of magnetostimulation into the comprehensive treatment of leg ulcers had a positive effect on the acceleration and improvement of the effectiveness of ulcer healing.
Clinical and experimental studies increasingly demonstrate the positive impact of variable magnetic fields, including those with physical properties characteristic of magnetostimulation, on the wound healing process. The cell membrane is particularly sensitive to variable magnetic fields. This mechanism is probably indirectly related to the polarization of cell membranes under the influence of a magnetic field, which favors the movement of thromboplastic factors to the surroundings and inside cells. The tendency to reduce blood clotting and its aggregation properties under the influence of an alternating magnetic field leads to improvement of venous flow and microcirculation in the area of ulcers, favoring the stimulation of the healing process. The variable magnetic field used in magnetostimulation treatments also activates glutathione peroxidase, leading to the inhibition of phospholipid peroxidation and stabilization of cell membranes, and also stimulates the erythropoiesis process and significantly accelerates the development of collateral circulation in damaged tissues, which leads to improved blood supply and microcirculation in the tissues around the ulcer [15–18].
According to some authors, one of the main mechanisms of the regenerative effect of an alternating magnetic field is also the stimulation of the processes of diffusion and oxygen uptake by hemoglobin and cytochromes, which intensifies the process of oxygen utilization and tissue respiration in tissues exposed to its influence [15, 19].
Another manifestation of the stimulating effect of magnetostimulation on tissue regeneration processes is the stimulation of cell proliferation under the influence of a magnetic fields. The intensification of cell proliferation under the influence of an alternating magnetic fields may be facilitated by the stimulation of the production of interleukins IL-1 and IL-6, demonstrated, among others, by: in human blood mononuclear cells exposed in vitro to an alternating magnetic field [15, 17].
Many experimental studies have also confirmed the acceleration of the histological maturity of wounds, as well as a significant increase in the content and maturity of collagen (higher density of collagen fibers and their more regular arrangement) and the earlier appearance of new capillaries in the wound [20–22]. According to our experience, magnetostimulation also has a pronounced local anti-inflammatory, anti-edematous and analgesic effect (related to the modification of the activity of the endogenous opioid system), as well as inhibiting destructive processes and stimulating immune reactivity. In the case of infected ulcers, exposure to an alternating magnetic field increases the effectiveness of their healing by accelerating the process of cleansing them of necrotic tissues, increasing sensitivity to antibiotic therapy, faster reduction and elimination of purulent foci, and consequently reduced the treatment time [9, 10, 23].
It should be emphasized that the conventional treatment of the ulcer used in the patient did not show full effectiveness over the previous 6 months, and the addition of magnetostimulation resulted in complete healing of the ulcer after only 3 weeks of using this method as part of a comprehensive therapeutic procedure, which, according to the current guidelines on treatment principles, is difficult to achieve. Healing of wounds also included the daily use of pharmacological agents, dressings and compression therapy. It is also important that the improvement in the intensity of the ulcer healing process was accompanied by a significant alleviation of the pain experienced by the patient.
Fernández-Guarino et al. indicated that the use of magnetic fields in medicine is one of the oldest and natural methods of treatment, although their potential is not fully exploited. The effectiveness of these treatments depends to a large extent on the type of the disease, the severity and duration of the lesions, and above all, on the early start of their application and systematic performance of the treatments in accordance with applicable procedures and strict compliance with the therapist’s recommendations by the patient. The authors proposed a translational view, opening the possibility of optimal development of these therapies in comprehensive clinical management, emphasizing in particular the role of laser therapy, photobiomodulation, photodynamic therapy, electrical stimulation, and methods using an alternating magnetic field [25].
Mohamady et al. evaluated the effects of combined pulsed electromagnetic field (PEMF) therapy and plantar flexion resistance exercise (PRE) in patients with VLUs. Sixty patients with venous ulcers were randomly assigned to 1 of 3 groups. For up to 12 weeks, the first group received PEMF and PRE therapy in addition to conservative treatment of ulcers. The second group received only PEMF therapy in addition to conservative ulcer treatment, while the third group served as a control group and used conservative ulcer treatment. During a four-week follow-up, both groups treated with PEMF showed a significant reduction in the area and volume of ulcers, with no significant changes in the control group [26].
Pasek et al. compared the therapeutic effectiveness of two methods of physical medicine – magneto-LED therapy and magnetostimulation, used as complementary treatment of VLUs. The study included 81 patients with VLUs assigned to two research groups: magnetoLED therapy (group 1) or magnetostimulation (group 2). A total of 40 daily treatments were performed in both groups. The effectiveness of ulcer healing was assessed using computer planimetry, and the pain intensity was assessed using a VAS numerical rating scale. After completion of treatment, a statistically significant reduction in the area of ulcers was achieved in both groups (p < 0.001) and a statistically significant reduction in pain intensity (p < 0.001), with most effectiveness in both ranges achieved after the use of magnetic field therapy [27].
Yim et al. conducted a systematic review of the current literature on the impact of physical therapy on ulcer healing and quality of life in patients with VLUs and attempted to identify research gaps that warrant further research. In the PubMed (MEDLINE), CINAHL and Cochrane databases, the authors found 10 articles presenting the results of randomized and single-arm cohort studies on small samples in which physiotherapy treatments were used in patients with open or healed VLUs. The authors pointed out that although there is evidence that physiotherapy interventions have a beneficial effect on the quality of life and ulcer healing, there is still a lack of clear evidence and randomized clinical trials in this area [28].
In the review by James et al., the authors presented a systematic approach to the comprehensive treatment of VLUs based on previous literature and the authors’ clinical experience, taking into account wound size, etiology and response to previous treatment, analyzing therapeutic techniques including wound debridement (autolytic, enzymatic, acute/surgical), compression therapy, physical therapy, supportive care, and cell and tissue therapy. The authors emphasized that only after making the correct diagnosis can the appropriate treatment be selected, which should result in a significant reduction in the ulcer area and/or closure of the ulcer [9].
It is hoped that further clinical studies confirming the effectiveness of magnetostimulation procedures will allow these treatments to be included into clinical practice as part of comprehensive treatment programs for difficult-to-heal wounds, including chronic VLUs.

Conclusions

In this described case, the use of a series of magnetostimulation procedures resulted in complete healing of the ulcer and a significant reduction in the intensity of pain ailments.
It seems that the use of magnetostimulation in the comprehensive treatment of difficult-to-heal leg ulcers of venous etiology may bring significant therapeutic benefits, but confirmation of these results requires to be examined/confirmed on a larger research group.

Disclosures

1. Institutional review board statement: The patient signed written informed consent for participation in this study and the publication of the accompanying images.
2. Assistance with the article: None.
3. Financial support and sponsorship: Not applicable.
4. Conflicts of interest: The author’s declare no conflict of interests.

References