ALMAG®-01 device was applied for treatment of diabetes mellitus complications (also called diabetic foot) from October 2005 through November 2008.
Diabetic foot syndrome is a complex of functional anatomic changes that can take various forms and occur in 30-80 % of patients with diabetes.
Lower extremities amputation takes place 15 times more often among this group of patients, as opposed to the people without diabetes. Numerous studies suggest that the majority (50 – 70%) of all lower extremities amputations is associated with diabetes mellitus patients.
In pathogenesis of diabetic foot syndrome development there are three major factors:
lower extremities arteries lesion;
The last factor, as a rule, is a concomitant one related to the first two forms. Based on predominance of either neuropathological changes or peripheral blood-flow abnormalities there are two main clinical forms of diabetic foot syndrome:
Alongside the two basic forms of diabetes mellitus lower extremities lesion there is the third one:
- mixed (neuro-isch(a)emic).
Neuropathic form can be followed by somatic and vegetative nervous system lesion with lower extremities arterial segments intact. Neuropathy can result in foot lesion of three types as follows:
- neuropathic sore (ulcer);
- osteoarthropathy (further on with the neurogenic development
- neuropathy edema.
The ischemic form is developing as a consequence of atherosclerotic changes in lower extremities arteries resulting in a malfunction of main blood-flow as well as neuropathic changes. However decrease or complete absence of pulsation in feet and shins, cold extremities while in palpation, the pain symptomatology as well as sore defects individual localization similar to acral necrosis allow to differentiate both neuropathyic and mixed (neuro- isch(a)emic) changes in feet.
With the count of multifactorial etiopa thogenesis and the diversification of diabetic foot clinical symptoms, there is an urgency of given pathology new rehabilitation methods development with the purpose to increase the clinical efficiency of treatment.
In the arsenal of applied treatment methods for given disease the important place is given to the application of natural and physiotherapy producing both local and general (systemic) effect, as well as adaptive reactions. It also activates body reserved potential directed to eliminating the pain syndrome, correcting vascular abnormalities, improving functional state of the nervous system.
Numerous clinical trials testify a wide range of medical benefits and high efficiency of low-frequency pulsed electromagnetic fields. Local exposure to low-frequency pulsed electromagnetic fields produces obvious anti-inflammatory, spasmolytic, analgetic, trophic-regenerative effect (Prato p.8). Magnetic field improves perineural sheath microcirculation and myelin sheath trophic function, facilitates normalzation of neuro-muscular apparatus functional state. Technical feasibility of the majority of modern physiotherapeutic devices producing low-frequency magnetic field is different depending on the area of their action, thus limiting the usability of each particular device. Considering this fact, the availability of remote strip - line inductors (coils assembly exposure unit) of «ALMAG®-01»device provides the possibility to alternate actions on the patient covering the whole body thus increasing efficiency of magnetotherapy use for the given nosology treatment.
In Vladimir Regional Clinical Hospital trials of low-frequency travelling magnetic field, generated by «ALMAG®-01»physiotherapeutic device were carried out on patients with diabetic foot syndrome (the conscience of diabetes mellitus I-st type). «ALMAG®-01»device is manufactured in JSC «Yelama Instrument-Making Enterprise», Russia.
The purpose of the trial was to study «ALMAG®-01»low-frequency travelling magnetic field physiotherapeutic device application expediency and efficiency for patients with diabetic foot syndrome and neuro-isch(a)emic forms of diabetes mellitus I-st type.
Clinical trial was carried out within 3 months. All patients were divided into 2 groups depending on age, disease duration, cliniсal-neurologic status principal. The first group (104-persons) - patients with diabetic foot syndrome - were treated with «ALMAG®-01» device physio-therapeutic action on lumbosacral area according to cross (transverse) and line technique over both lower extremities front surfaces.
The second control group (98 persons) - patients with diabetic foot clinical symptoms - did not experience magneto-therapy procedures on lumbar area and lower extremities.
Within the observation period the patients took the basic treatment.
The patients of the 1st group were exposed to «ALMAG®-01»low-frequency travelling magnetic field with remote strip - line inductors (coils exposure assembly-unit) on lumbosacral area according to transverse and line technique over the both lower extremities’ front surfaces. Treatment procedure exposure time: 7 min on each area. Magnetic field exposure mode: frequency - 6,25 Hz, magnetic induction amplitude value - 20 mTl. Treatment course includes 10 daily procedures.
Clinical characteristics of the patients:
Under observation there were 202 patients with diabetic foot clinical symptomes, disease duration - from 0,5 to 8 years. Among the patients there were 88 (57,5 %) men and 114 (42,5 %) women at the age of 44 - 72 years old, patients average age - 58 years old.
26 patients with disease duration from 0,5 to 1 year; 112 patients - from 1 to 3 years, 14 patients - from 3 to 6 years, 64 patients - from 5 to 8 years
Lower extremities rheovasogram analysis revealed that 47 % of the patients had vasomotor spasm features as follows: decrease of reowave amplitude, length of anacrotic phase time, shift dicrotic peak at the top of curve, decrease of renography index (RgI) and increase of peripheric resistance parameter - dicrotic index (DcI) indicating fine vessels` increased tone.
Disease clinical picture: complaints of pains, cold, numbness of the lower extremities. At examination there were observed vegetative disturbances, such as: color change in both both skin and nails, skin dryness, foot hyperkeratosis and pastose.
Upon «ALMAG®-01»device treatment course termination there were carried out subjective and objective assessment of treatment efficiency. In the whole treatment procedures tolerance was good. As a result of treatment most of the patients marked the improvement of general health condition, there were positive changes of disease subjective and objective clinical picture. Efficiency analysis (both improvement of patients health well-being or disease examined parameters) has shown the obvious positive clinical effect in 59 % of the cases.
The conducted treatment showed (visual analog scale data measured in sm) the following results: intensity of pain syndrome decrease from 4,8 ±1,5 to 2,1 ±1,6 points, whereas in control group the decrease measured up to 3,5±0,5 points.
In the basic group there was marked a tendency of both of systolic and, to a great extent, diastolic arterial pressure decrease that was probably explained by the effect of peripheric vasodilation as a result of magnetic field exposure (table 2).
Rheovasographic (RVG) trials showed "АLMAG®" device favorable effect, namely regional hemodynamics improvement of rheography curves form and structure and RVG quantity indexes. However, these positive changes basically concerned patients with vasospastic type of peripheric circulation. There was marked an increase of initially reduced rheography index (RgI) (57 % of the patients with initially decreased RGI) indicating both an increase of lower extremities pulse blood filling; a decrease of fine vessel tone as decrease of initially high values of dicrotic index (DcI) (64 % of the patients), reduction of DAPI testifying the improvement of venous outflow (71 % of the patients).
In the basic group 28 % of patients with hypotonic type had evident reduction of initially increased RgI, DAPI and increase of initially reduced DcI, whereas 45 % the patients had increase of RgI probably as a result of magnetic field vasodilating effect.
Thus, «ALMAG®-01" device magnetic field therapy in patients with diabetic foot consequence of neuropathic sore (ulcer) clinical symptoms facilitated both decrease of pronounced pain syndrome and sensitive disturbancies; improvement of peripheric hemodynamics parameters followed by change of affected extremities skin colour, acceleration of ulcerative defect healing.
Positive subjective and objective changes have been detected as the result of «ALMAG®-01»device pulsed travelling magnetic field physiotherapy on lumbar spine and lower extremities. The clinical picture of the disease after «ALMAG®-01” application was as follows: improvement of the patients` general well-being, moderate analgesic and spasmolytic effect, moderate hypotensive action with full absence of by-effects. Vasodilating effect as a result of «ALMAG®-01»device pulsed travelling magnetic field physiotherapy application for the patients with neurovascular changes of diabetic foot as a consequence of diabetes mellitus of 1st type complication, represents itself the great interest and requires further detailed study regarding to its wider application in complex treatment for patients with nosological form.
Considering the present trial results we are able to recommend the application of «ALMAG®-01» device pulsed travelling magnetic field physiotherapy in complex treatment for patients with diabetic foot.
Vladimir region health institution,
The head of physiotherapeutic department,
The leading physiotherapy expert L.A.Chernyavskaya.