CLINICAL TRIALS

VLADIMIR PROVINCIAL OFFICE OF STATE OF PUBLIC HEALTH <<PROVINCIAL CLINICAL HOSPITAL>>

600023, city Vladimir, route Sudogorodskoye, 41, phone/fax 4922-32-61-79

E-mail: vlad_okb@vtsnet.ru

№ 869   from  May 13, 2009 

Device ALMAG-01 adapted from October 2005 to November 2008, in the physical therapy department for treating the complications of diabetes mellitus -diabetic foot. The syndrome of diabetic foot is the elaborate complex of anatomist- functional changes, which is encountered in various forms in 30-80% of patients with diabetes mellitus. The amputations of lower extremities in this group of patients are produced 15 times more frequently than in remaining population. According to the data of a number of the authors from 50 to 70% of a total quantity of all of those executed of the amputation of lower extremities it falls to the share of the patients with diabetes mellitus. In the pathogenesis of the development of the syndrome of diabetic foot key place occupy three basic factors:

-neuropathy;

-the involvement of the arteries of lower extremities;

-infection.

Last factor is, as a rule, associated with respect to two first. On the basis of the predominance of neuropathic changes or disturbances of peripheral blood flow are distinguished two basic clinical forms of the syndrome of the diabetic foot: -neuropathic;

-ischemic;

Together with two basic forms of the defeat of lower extremities with diabetes mellitus also they separate third: - mixed (neuro- ischemic).

In the neuropathic form occurs the defeat of somatic and vegetative nervous system with the intactness of the arterial segments of lower extremities. Neuropathy can possibly lead to following three involvements of the feet:

-neuropathy of the ulcer;

-osteoarthropy (with the subsequent development of Charcot’s joint);

-neuropathic edemas.

Ischemic form is developed as the consequence of the atherosclerotic defeat of the arteries of lower extremities, which leads to the disturbance of main blood flow. In this case can occur also neuropathic changes. However, a decrease or the complete absence of pulsation on the arteries of feet and shins, cold during the palpation extremities, painful symptomatology, and also characteristic localization of ulcerous defects according to the type of acral necrosis make it possible to differentiate the neuropathic and mixed (neuro- ischemic) forms of the defeat of feet.

Taking into account multifactorial of etiopathogenesis and variety of the clinical manifestations of the syndrome of diabetic foot, remains urgent the development of the new methods of the rehabilitation of this pathology for the purpose of an increase in the clinical effectiveness in the treatment.

In the arsenal of the methods of treating this disease used important place is assigned to the use of the natural and preformed physical factors, which render both local, and general action, causing adaptive reactions, the making more active of the reserve possibilities of organism and directed toward stopping of painful syndrome, correction of vascular disturbances, improvement in the functional state of nervous system.

Numerous studies testify about the wide therapeutic possibilities and the high efficiency of low-frequency pulse electromagnetic pour on, whose local action renders the expressed antiedematous, resorbing, antipyretic, spasmolitic, anaesthetizing, trophicity-regenerative action (Prato F. S. 2000). Magnetic field improves microcirculation in the perineural shell, trophic function of myelinic shell; it contributes to the normalization of the functional state of neuromuscular device.

The technical capabilities of the majority of the contemporary physical therapy devices for those generating low-frequency magnetic field are limited on the area of maximum action on all pathogenetically and clinically significant regions of defeat. In connection with this, the presence in the device “ALMAG-01” of strip extension inductors makes it possible to provide the possibility of successive action on the large area of patient (body, foot), increasing the effectiveness of the application of magnetotherapy with this nosology.

IN VOGUZ of OKB were conducted the clinical tests of action by the low-frequency scanning magnetic field by the generatable physical therapy device “ALMAG-01” in patients with the syndrome of diabetic foot with I type diabetes mellitus.

Device “ALMAG-01” is produced in Russia: Joint stock Company “Elatomskiy instrument plant”

The purpose of a study was the study of expediency and effectiveness in the application of the low-frequency scanning magnetic field generated by physical therapy device “ALMAG-01” in patients with the syndrome of diabetic foot, neuro- ischemic form with I type diabetes mellitus.

Diagram of the clinical experiment of the effectiveness of “ALMAG”

Table 1

Day 1

1-14 days

Day 14

Clinical status

X

X

X

the Visual- analog scale of the pain

X

X

Clinical the analysis of the blood

X

X

Biochemical the analysis of the blood (level of blood sugar)

X

Analysis of the urine

X

X

[Reovazografiya]    the lower extremities

X

X

EKG
Course of magnetotherapy

X

X

X

A study continued 3 months. All patients were divided into 2 groups the comparable with respect to the age, duration’s diseases, to clinic- neurologic status:

I         group (104 people) – patients with the clinical manifestations of the diabetic foot, which obtained action from the physical therapy device   “ALMAG-01” to the lumbar- sacral region employing transverse procedure is linear over the front surface to both lower extremities.

II         group (98 people) – patients with the clinical manifestations of the diabetic foot, which did not obtain magneto therapeutic procedures on   lumbar   region and lower extremities (control group) In the period of observation the patients obtained base treatment.

Procedure of the treatment:

The patients of the I group obtained action by the running low-frequency field from the physical therapy device“ALMAG-01” by extension strip inductor first to the lumbar- sacral region employing transverse procedure and it is linear over the front surface to both lower extremities. The regime of action comprised – on 7 minutes to each region. The regime of action is fixed, it is 6,25 Hz and 20 mT. Procedures were conducted daily, to the course of 10 procedures.

Clinical characteristic of the patients

Under the observation were found 202 patients with the diabetic foot, the clinical manifestations of diabetic foot with a duration of disease of from 0,5 to 8 years, including 88 (57,5%) of man even 114 (42,5%) women at the age from 44 to 72 years, the average age of patients comprised   58 years.

The duration of disease from 0,5 years to 1 year was observed in 26 patients, from 1 to 3 years in 112 patients, from 3 to 6 years in 14, from 5 to 8 years in 64 patients.

The analysis of rheo-vasogram of lower extremities revealed in 47% of patients the signs of the angiospasm in the form of reduction in the amplitude of rheo-waves, lengthening of the time of anacrotic phase, displacement of dicrotic tooth in the apex of curve, and also reduction in the rheo-graphic index (RI) and the increase in the index of peripheral resistance-the dicrotic index (DCI), which reflects the increased tone of small vessels.

The patients with form presented complaints on the pain, sensitiveness to cold, numbness of lower extremities. With the inspection were observed the vegetative disturbances in the form of a change of painting of the skin, nails, the dryness of the skin, hyperkeratosis and pastiness of feet.

Results of a study:

On the completion of the course of action by “ALMAG-01” was conducted the subjective and objective evaluation of effectiveness in the treatment. As a whole the transference of procedures was grow prettier. As a result carried out treatment in the majority of patients was improved the general state, positive changes in the subjective and objective manifestations of disease occurred. The analysis of effectiveness (substantial improvement or an improvement in the indices) showed that the clinical effect was observed in 59% of cases

As a result carried out treatment, according to the data YOUR of pain (measured in cm), the intensity of painful syndrome was reduced from 4,8 ±1,5 of mark to 2,1 ±1,6 of mark, whereas in the control group to 3,5±0,5 of mark

In the basic group was noted the tendency toward a decrease in both the systolic (САD) and, to the larger degree, diastolic (DAD) arterial pressure, which is explained, probably, by the effect of peripheral vasodilation of that observed under the influence by the magnetic field (table 2)

Dynamics of arterial pressure in the patients of the dorsopathy of the lumbar division of the spine                                                                                                                                            Table 2

САP DAP

Before the treatment

After the treatment

Before the treatment

After the treatment

Group 1

139±4,6

123±3,6*

87,8±4,4

68,4±6,6*

Group 2

136±6,5

129±7,8

86,6±7,3

82,2±7,4

*-Р<0,05

Rheovasographic studies showed the favorable influence “OF [ALMAG]” on the regional hemodynamics of the patients in the form of an improvement in form and structure of rheographic curved, quantity indicators RVG. However, these positive changes in essence concerned patients with the vaso-spastic type of peripheral blood circulation. Is noted increase initially decreased RI (in 57% of patients with initially decreased RI, which characterizes an increase in pulse hyperemia of lower extremities; also was observed reduction in the tone of the small vessels in the form of reduction in the originally high values of DcI (64% of patients). In 71% of patients is noted reduction in the DI, which indicates an improvement in the venous draining.

In patients with the hypotonic type RVG is noted the reliable decrease initially increased RI, DI and an increase in that initially lowered of DcI in the basic group in 28% of patients, whereas in 45% occurred an increase in RI and which is connected in with the vasodilation effect of magnetic field.

Table 3

Dynamics of the indices of rheovasographic of the lower extremities of the against the background conducted treatment “BY ALMAG-01”

Groups of the patients

RVG indicators

Values

1 group (p=104)

RI (Ом)

0,49±0,07*

0,74±0,05

DcI (%)

43,5±1,9* 36,2±1,27

DI (%)

39,7±2,6 35,8±1,8

2 group (p=98)

RI (Ом)

0,48±0,08 0,62±0,1

DcI (%)

43,9±1,8 39,4±1,9

DI (%)

40,2±1,6 39,2±1,7

Note: p – a quantity of patients;

in numerator indices before the treatment,

in the denominator after the treatment *Р<0,05

Thus, course treatment by action by magnetic field by the generatable device “ALMAG-01” in patients with the diabetic foot, the clinical manifestations of neuropathic ulcer contributed to the decrease of the manifestation of the painful syndrome, sensory disorders, indicated improvement of peripheral hemodynamics, which was accompanied by change in the color of the skin of the struck extremities, by acceleration of the healing of the ulcerous defect.

Conclusion:

The revealed positive subjective and objective changes against the background in the course of physical therapy action by the pulse scanning magnetic field from the device “ALMAG-01” to the lumbar region and the lower extremities. This action rendered an improvement in the general health of patients, the moderate anaesthetizing action, spasmolitic effect, moderate hypotensive action with the complete absence of side effects. The obtained vasodilation effect in patients with the neurovascular changes with the complication of I type diabetes mellitus of diabetic foot is the increased interest and further more careful study in the plan of the wider application of a method in patients with the investigated nosologic form.

Thus, the results of the carried out clinical experiments make possible to recommend the course of physical therapy action by the pulse scanning magnetic field from the device “ALMAG-01” to the lumbar region and lower extremities for patients from the diabetic foot in the complex treatment.

Director of the physical therapy department

Chernyavskaya L. A.

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