RU2322247C1 - Method for treating ulcerous defects at diabetic foot syndrome - Google Patents

Abstract

FIELD: medicine, purulent surgery.

SUBSTANCE: it is necessary to apply dressings with suspension consisting of thrombocytes-rich plasma, 10%-CaCl₂ solution at equal volume and antibacterial preparation to which ulcerous microflora is sensitive. The volume of dressing for 1 dressing should be determined by the following formula: V=S×h×C, where S - the area of ulcerous defect, h - its depth, C - the coefficient. At the rate of ulcerous surface epithelization being under 25% weekly C=1.25, and at the rate being above 25% weekly C=1.0. The innovation provides the chance for individual dosing autogenous tissue growth factors and matched efficient antibacterial preparations and, thus, accelerated phase II of wound process and shortened terms of epithelization of ulcerous defects in the present category of patients.

EFFECT: higher efficiency of therapy.

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Description

The invention relates to medicine, namely to purulent surgery, and can be used to treat long-term non-healing ulcers in diabetic foot syndrome.

Diabetic foot syndrome is one of the serious complications of diabetes. From 40 to 70% of all non-traumatic amputations in the world are produced in patients with diabetes mellitus [1]. According to the Diabetic Foot Center of the International Diabetes Program, in 19.4% of cases of amputation, a long, non-healing foot ulcer precedes. The average duration of treatment for these patients is 4 months, and for 10% of patients - more than a year [2]. This is due to the fact that the course of the wound process in patients with diabetes mellitus has its own characteristics, namely a low rate of epithelialization of the ulcer surface, a tendency to generalize the infectious process, and a negative effect on the chronic kidney failure reparative processes. From the literature, the significance of growth factors and cytokines in the treatment of chronic ulcers and long-term healing wounds is known, and a significant decrease in the level of growth factors in patients with diabetes is also indicated [3].

A new area of surgery is the use of platelet-rich plasma to accelerate regeneration processes. Platelet-rich plasma is an autogenous source of growth factors, which is obtained by dividing whole blood by a density gradient. Platelet-rich plasma contains a high concentration of platelet-derived growth factor and transforming growth factor [4].

A study of patent and medical literature has revealed the following methods that are used to treat ulcers in diabetic foot syndrome.

A known method of treating diabetic foot syndrome [5] by using ozone. The method provides for the intra-arterial administration of an antiseptic - ozonized physiological solution in combination with local exposure to ozonized physiological solution in two stages. At the first stage, purulent necrotic tissue is removed with a stream with a pressure at the outlet of 80 atmospheres. At the second stage, tissues are infiltrated with a jet with a pressure at the outlet of 150 atmospheres. In a particular case, intraarterially ozonized physiological saline is administered in a therapeutic dose up to 5 times a day with a course of treatment up to 15 days.

The disadvantages of the method are due to the fact that it does not provide for the additional introduction of autologous factors that accelerate the epithelization of a peptic ulcer. Intraarterial administration of ozonized saline increases the number of medical invasions and increases the number of “entry gates” of infection into the systemic circulation against the background of severe immunosuppression. Infiltration of tissues with ozonized physiological saline under high pressure will lead to mechanical damage to the latter, which will adversely affect the course of the wound process and can contribute to the generalization of inflammation.

A known method of treating diabetic angiopathy of the lower extremities [6], which includes improving microcirculation by exposing the patient to centrifugal forces in the direction of the head-lower limbs. The rotation speed of the centrifuge is 36-42 rpm. The treatment regimen is determined by the achievement and maintenance of gravitational hyperemia of the lower extremities and an increase in regional blood flow, as evidenced by an increase in the photoplethysmogram coefficient of the feet, measured by the formula.

An analogue cannot be used to treat an infectious lesion of the soft tissues of the foot. The analogue is contraindicated in patients with diseases accompanied by increases in cerebral and coronary blood flow, as well as conditions accompanied by changes in the state of aggregation of blood and a tendency to thrombosis. For the application of the method requires special equipment, which significantly limits its clinical use.

A known method of treating destructive forms of diabetic foot syndrome [7], used for local treatment of patients with diabetes mellitus with purulent-necrotic complications on the foot and high resistance of microorganisms to antibiotics. The method consists in the use of a drug that reduces the resistance of microbes to antibiotics, which is used as a 1% solution of hydrochloric acid, which is applied in the form of a wet dressing on a wound surface previously coated with an antibiotic. Dressings are repeated daily until fresh granulations appear.

The disadvantages of the method are that the application of a 1% hydrochloric acid solution to a purulent wound can only lengthen and "strengthen" the hydration phase of the wound process without exerting a positive effect on the regeneration of tissues prone to purulent inflammation due to the effect of a 1% hydrochloric acid solution, "Reducing the resistance of microbes to antibiotics."

There is a method of treating trophic ulcers against the background of diabetic foot syndrome, in which autolymphocytes treated with glutoxim 20 mg for 45 minutes are injected into the femoral artery of the affected limb. Autolymphocytes are obtained on an AS-TEC 204 blood cell plasma separator from Fresenius. The procedure is carried out twice with an interval of 48-72 hours [8].

The disadvantages of the method are that it does not directly affect the affected soft tissues, the method does not involve individual use, taking into account the sensitivity of the selected antibacterial drugs.

A known method of surgical treatment of chronic ischemia of the lower extremities, as well as diabetic foot syndrome, in which several trepanation channels located at different angles are performed from one access and conductors are additionally inserted into them through which additional subsequent exposure to bone marrow is performed by low-intensity laser radiation with the time of its total effect on the bone marrow in one session from 5.0 to 30 minutes and intraosseous administration of drugs of these drugs, as an external physiotherapeutic effect, they use exposure to ultrasound with a frequency of 880 kHz and an intensity of 0.4 W / cm for 5-6 minutes in one session, carried out in the projections of the zones of the performed channels and along the main vessels, and the number of sessions of exposure to ultrasound and low-intensity laser radiation is at least five, which ensures blood supply to the limb [9].

The disadvantages of the method are due to the lack of techniques to accelerate the epithelization of a peptic ulcer, to suppress infectious inflammation, in addition, the mechanical effect on the bone of patients with diabetes can lead to the development of complications such as deep intermuscular phlegmon and osteomyelitis.

A peripheral blood circulation improving agent is known to be used to treat diabetic foot syndrome. The invention lies in the fact that the proposed tool for improving peripheral circulation of local action contains both nitroglycerin and aminophylline in leform for local action. The tool can be made in the form of an emulsion, gel, ointment [10].

The method has the following disadvantages - it does not provide effects on the wound surface with autogenous tissue growth factors and antibacterial drugs.

A known method of treating purulent wounds by exposure to a stream of antiseptic under pressure, characterized in that the wound is exposed to a stream of antiseptic with an outlet pressure of 40-50 atm from a distance of 8-10 cm from its surface, then a fine stream of ozonized solution with an outlet pressure of 70-90 atm from a distance of 2-3 cm from the surface of the wound with an exposure of 4-5 s / cm ^{2 the} area of the wound daily until granulation appears, after which granulation is irrigated with a fine stream of ozonized solution at a pressure of 10-15 atm daily to complete epithelization of the ra us [11].

The disadvantages of the method are due to the fact that it does not provide for the additional introduction of autologous factors that accelerate the epithelization of a peptic ulcer. Irrigation of tissues with ozonized physiological saline under high pressure will lead to mechanical damage, which will adversely affect the course of the wound process and may contribute to the generalization of inflammation.

The prototype of the present invention as the closest in combination of features to the claimed method, a method for the treatment of ulcerative defects in diabetic foot syndrome [12], including the use of Activtex wipes with various active substances in a certain sequence, was selected.

The disadvantage of this method is the absence of Autogentex tissue autogenous tissue growth factors accelerating phase II of the wound process and epithelization. In addition, when using Activtex wipes, it is impossible to carry out individual selection of antibacterial drugs.

The task of the invention is to accelerate the second phase of the wound process, conducting local antibiotic therapy in combination with stimulation of epithelialization of the ulcer surface.

The task is achieved by the fact that when dressings use a suspension consisting of a platelet-rich autoplasma of an antibacterial drug to which the microflora of the ulcer is sensitive, and CaCl ₂ , the suspension volume is determined by the formula, taking into account the size of the ulcer and the rate of epithelization.

The method is as follows. 200-300 ml of autogenous blood is drawn through a central venous catheter at a speed of 50 ml / min into a centrifuge that rotates at a speed of 5600 rpm. When taking blood to prevent coagulation, a preservative (cytroglucophosphate) is automatically added in the ratio of 1 ml of preservative to 5 ml of blood. In a centrifuge, blood is divided into three fractions: red blood cells, platelet-rich plasma and platelet-poor plasma. The first platelet-poor plasma (about 150 ml) is separated. After the platelet-poor plasma is separated, the centrifuge rotational speed is reduced to 2400 rpm for a more accurate separation of platelet-rich plasma and red blood cells. Then platelet-rich plasma (about 70 ml) is separated, the erythrocytes (about 180 ml) are the last to be separated. The plasma acquires a straw-yellow color and is placed in a bag (container) for storing blood products. It is stored in the refrigerator. Before use, 10 ml of platelet-rich plasma is drawn into a syringe, then 10 ml of a 10% solution of calcium chloride (CaCl ₂ ) is added. The syringe is shaken before coagulation begins, and then its contents are mixed with an antibiotic (to which there is a sensitivity of microorganisms).

The volume of suspension with biologically active substances required for one dressing is calculated by the formula: V = SxhxK, where S is the area of the ulcer defect, h is the depth of the ulcer defect, K is the coefficient.

When the rate of epithelialization of the ulcer surface is less than 25% per week K = 1.25, when the rate of epithelization of the ulcer surface is more than 25% per week K = 1.

The suspension is superimposed on the surface of a sluggishly granulating ulcer. Dressings are performed 2 times a day. Antibacterial therapy is carried out taking into account the sensitivity of microflora, symptomatic therapy of diabetes mellitus.

The method was tested in 14 patients in the surgical department of MLPUZ GB No. 7, Rostov-on-Don.

An example of a specific implementation of the method.

Patient D., 64 years old, was admitted to the surgical department on 06/14/2005 with complaints of the presence of an extensive long-term non-healing ulcer on the plantar surface of the right foot. For 15 years he has been ill with type 2 diabetes, severe course, 5 months. back on the plantar surface of the right foot ulcer formed, gradually increasing in size. It was treated on an outpatient basis with insignificant effect - flaccid granulation appeared. At admission: general condition of the patient of moderate severity. Pulse 72 per minute. HELL = 130/75 mmHg An examination revealed a neuro-ischemic form of diabetic foot syndrome with a predominance of neuropathy, 3 tbsp. At the initial examination: on the plantar surface of the right foot in the area of the 1st metatarsophalangeal joint there is an ulcer of 3 × 4 × 1.2 cm, the bottom is made of flaccid granulation tissue with fibrin overlay sites. The edges of the ulcer are “undermined”, represented by hyperkeratosis. When radiography: pronounced phenomena of osteoporosis of the head 1 of the metatarsal bone and the main phalanx of 1 finger. When taking a deep biopsy, Staphylococcus aureus sensitive to ceftrioxone was detected. An immunological study of ulcer tissue showed a sharp decrease in T-cell and epidermal growth factors.

The diagnosis was established: type 2 diabetes mellitus, moderate severity, neuro-ischemic form (with a predominance of neuropathy) of diabetic foot syndrome of the 2nd degree, trophic ulcer of the right foot. Glucose-correcting and neurotropic therapy are prescribed.

Suspension preparation was carried out in accordance with the developed methodology.

During the first ligation, the edges of the ulcer, represented by hyperkeratosis, were excised. 18 ml of suspension of platelet-rich plasma and ceftrioxone were applied to the ulcer surface. Dressings were performed twice a day. By the 5th day, marginal epithelization appeared. The volume of the mixture applied during dressings was calculated according to the presented formula. By 23 days, the ulcer was completely epithelized. At the same time, normalization of the epidermal growth factor was revealed. At the control examination after 6 months. plantar surface of the right foot with areas of hyperkeratosis, no ulcer.

Compared with the prototype, the proposed method for the treatment of ulcerative defects in diabetic foot syndrome reduces the time of epithelialization of the ulcer surface due to the use of autogenous tissue growth factors that accelerate the second phase of the wound process and epithelization. When using the developed method, an effective individual selection of antibacterial drugs is carried out.

Bibliography

1. Grandfather II with co-authors. Diabetic foot, M. 2005

2. Guriev Y.I., with co-authors. Diabetic foot. Is effective prevention possible? BC, Volume 9 No. 24, 2001

3. Myskina N.A., Tokmakova A.Yu., Antsyferov M.B. The process of repair of trophic ulcers in patients with diabetes mellitus "Problems of Endocrinology, 2004 vol. 50, No. 2, P.34-38.

4. Oral surg Oral med pathol Oral Radiol endod 1998, 85 P. 638-646.

5. RF patent 2154484 C2 from 2000.08.20.

6. RF patent 2227005 C2 from 2004.04.20.

7. RF patent 2184551 C2 from 2002.07.10.

8. RF patent 2228204 C2 from 2004.05.10.

9. RF patent 2228715 C1 of 2004.05.20.

10. RF patent 2246934 C2 from 2005.02.27.

11. RF patent 2068263 C1 of 1996.10.27.

12. RF patent 2178310 C1 from 2002.01.20.

Claims (1)

A method of treating ulcerative defects in diabetic foot syndrome by dressings with active substances, characterized in that the active substance is a suspension consisting of platelet-rich plasma, 10% CaCL ₂ solution in equal volume and an antibacterial drug to which ulcer microflora is sensitive , the suspension volume for one dressing is calculated by the formula V = SxhxK, where S is the area of the ulcer defect, h is its depth, K is the coefficient, and at an ulcer surface epithelization rate of less than 25% per week, K = 1.25, and at STI more than 25% during the K = 1.0.