RU2805258C1 - Method for treating purulent-necrotic lesions of the feet in patients with ischemic form of diabetic foot syndrome - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: used in the treatment of patients with purulent-necrotic complications of the neuro-ischemic form of diabetic foot syndrome. Balloon angioplasty of the arteries of the affected lower limb is performed. Then, on the next day, direct antegrade endolymphatic therapy is performed with the introduction of 10 ml of ozonized saline at a rate of 0.3-0.4 ml/min into a lymphatic catheter installed along the anterior surface in the middle third of the leg. Treatment lasts 5 days - one session per day. Ozonated saline solution is an isotonic sterile sodium chloride solution with an ozone concentration of 3.0-6.0 mg/l.

EFFECT: reducing the severity of subsequent surgery in patients, as well as reducing pain, the degree of bacterial contamination, and improving the leukocyte count of peripheral blood, while careful fixation of the catheter prevents its dislocation.

2 cl, 1 ex

Description

The invention relates to medicine and can be used in the treatment of patients with purulent-necrotic complications of the neuro-ischemic form of diabetic foot syndrome.

Among all the complications of diabetes mellitus, various foot lesions occur in 25-80% of patients, and 15% develop ulcerative-necrotic forms, often leading to amputations (Mosticheva M.G. et al., 2000; Rakhimova G.N. et al. , 2000; Svetukhin A.M. et al., 2003).

Against the background of the existence of prolonged ischemia of the limb against the background of diabetes mellitus, inflammation is often associated, which tends to be chronic, depleting the immune defense mechanisms and leading to an increase in the resistance of microorganisms to the main antibacterial drugs. Low immunoreactivity creates difficulties in interpreting the results of clinical laboratory parameters in assessing the course of purulent-necrotic changes in the feet (see Bychkova M.V., Trusov D.V., Kulyutsina E.R., Pochinina N.K.) Information content of leukocyte indices and sedimentation rate erythrocytes as indicators of chronic endogenous intoxication in the dynamics of inpatient treatment of patients with chronic rhinosinusitis and chronic tonsillitis. Effective pharmacotherapy. 2020; 17(37): 6-13).

The generally accepted position in choosing a method of treating lower extremity ischemia is the need to restore the main blood flow using reconstructive operations. Indications for endovascular treatment of chronic occlusive arterial diseases are determined by the location, extent and nature of the lesion. Every year, the range of minimally invasive interventions is expanding due to the improvement of X-ray surgical instruments and equipment.

There is a known method of treating neuro-ischemic diabetic foot syndrome using a surgical method - balloon angioplasty with a self-expanding stent with a delivery system for atherosclerosis of the femoral, popliteal and iliac arteries [Pokrovsky A.V., Dan V.N., Chupin A.V. Ischemic diabetic foot. In the book: Diabetic foot syndrome // I.I. Dedov et al. M., Universium Publishing. 1998. - P. 82-101., Bakal S., Sprayregen S., Schaeinbaum K. et al. Membranelipid alteration and Nat-pumping of the intrapopletea arteries, results in 53 patients // Am. J. Radiol. - 1990. - Vol. 154. - P. 825-831., Woefle K.D. et al. Distalvein gratt reconstruction for isolated tibio-peroneal occlusive in diabetics with critical foot ischemia How does it work // Eur. J. Vase. Surg. - 1993. - Vol.7. - P. 409-413].

Application BY No. 20101746 (A61B 17/00, A61M 5.00) describes a method of hybrid revascularization of the lower limb with multi-level occlusive-stenotic lesions of the arteries against the background of a neuro-ischemic form of diabetic foot syndrome, which consists in increasing the diameter of the deep femoral artery by performing open angioplasty with sewing in a synthetic patch, after which balloon angioplasty of the superficial femoral artery is performed.

There is a known method of hybrid surgical treatment of obliterating atherosclerosis of the arteries of the lower extremities (patent RU 2621395, A61B 17/00), in which simultaneous revascularization of the aortofemoral and femoral tibial segments of the arteries of the lower extremities is carried out by performing endovascular balloon angioplasty.

After restoration of blood flow in the lower limb, post-ischemic (reperfusion) syndrome develops. Before revascularization surgery, it is not possible to predict the severity and stage of reperfusion syndrome. This is influenced by a number of factors, such as the stage and duration of limb ischemia, the level of damage, the degree of damage to the great vessels and the volume of collateral circulation, the severity of diabetic microangiopathy and the possibilities of cellular adaptation mechanisms (see R.E. Kalinin, A.S. Pshennikov, I .A. Suchkov. Reperfusion tissue damage in surgery of the arteries of the lower extremities. News of surgery. 2015, 23(3):348-352).

Reduced blood flow is a leading factor that disrupts tissue repair processes, and in combination with infection, it is the main factor in lower extremity amputations.

Known works do not take into account the presence or absence of purulent-necrotic changes in the feet in the studied groups of patients; the influence of the existing infectious focus on blood circulation, including lymphatic drainage and antimicrobial protection; the influence of the lymphatic system on the development and progression of the infectious process on the foot after revascularization.

An infectious process on the foot against the background of chronic ischemia leads to the depletion of immune defense mechanisms. The role of the lymphatic system in the transport of toxins from the ischemic focus has been proven. When blood flow is restored in ischemic tissues in the presence of purulent-necrotic changes, an ascending infection may be activated and spread through the lymphatic bed.

Lymphatic methods of administering drugs recommended for widespread use by the USSR Ministry of Health are known. For these purposes, an injection or catheters are used, which are installed in the lymph nodes or vessels.

Endolymphatic administration of drugs allows more effective action on various infectious agents in close proximity to the source of inflammation (Panchenko R.T. et al. Endolymphatic antibiotic therapy. M. 1984).

It is known that bacteria and toxins actively spread through the lymphatic bed, therefore the use of methods of endolymphatic administration of antibacterial, detoxification and immunocorrective drugs helps maintain homeostasis of the body (see Vyrenkov Yu.E., Kataev S.I., Kharitonov V.V., Kodina T. .V., Kruglova I.S. Endolymphatic administration of drugs in the treatment of purulent-inflammatory diseases. Bulletin of the Ivanovo Medical Academy. 2015, 20(4): 57-63).

The known method is “Prevention and treatment of complications of accidental wounds and open fractures of the extremities” (RU 2330643, A61K 31/02, A61K 31/545, A61K 31/7036, A61K 31/727, A61K 31/14, A61K 38/21, A61P 41 /00, A61G 10/02, 2008), which consists of infusion of a complex of drugs by direct endolymphatic administration in a certain sequence. Local anesthesia is applied to the skin at the level of the dorsal surface of the tarsus on the foot or in the area of the dorsal surface of the metacarpus on the hand in an amount of 4-5 ml.

There is a known method of treating ischemic and purulent-necrotic lesions of the lower extremities by intraosseous administration of 100-150 ml of an ozone-oxygen mixture with an ozone concentration of 2500-500 μg/l for 20-30 minutes. A tourniquet is applied to the upper third of the leg and an injection is made near it (RU patent No. 2192866, A61Z 17/02, A61M 5/00).

There is a known “Method of endolymphatic treatment” (RU 2240148, A61M 25/00, 5/00, A61K 38/02, 38/04, 31/546, A61P 43/00, 2004), in which, under optical magnification, the wound is exposed through one surgical wound two peripheral lymphatic vessels; a catheter is installed in each of them. The lymphatic vessels of the foot are used.

In the method of direct endolymphatic ozone therapy (patent RU No. 2157250 A61M 5/00), the lower pole of the right superficial inguinal lymph node is isolated. The upper pole of the left superficial lymph node is isolated. The pulp of the lymph node is resected. The lymph node is catheterized with a subclavian catheter truncated in half. Use Ringer's solution with an ozone concentration of 2.0-2.5 mg/l 4 times a day for 8-12 days. 20 ml of solution is injected at a rate of 20 ml/hour into the lymph node.

There is a known method of direct antegrade endolymphatic infusion therapy according to Shulyak-Shulyak, according to which a freshly prepared ozonated Ringer-Locke solution with an ozone concentration of 4-5 mg/l and a solution of 0.03% sodium hypochlorite are administered through a catheter installed in the lymph node, 2 times a day within 4-14 days (RU patent No. 2218101, A61B 17/00, A61M 5/00).

The listed methods do not take into account the fairly high mobility of the skin and underlying soft tissues in the catheter area, which requires careful fixation to prevent catheter dislocation.

The objective of the invention is to reduce the likelihood of an ascending infection in reperfusion syndrome of the lower limb after revascularization in patients with purulent-necrotic complications of diabetic foot syndrome against the background of limb ischemia and to prepare the patient for subsequent sanitation of a purulent-necrotic lesion of the foot.

The technical result is a reduction in the volume (severity) of the subsequent operation in patients and pain, a decrease in the degree of bacterial contamination, an improvement in the leukocyte count of peripheral blood, careful fixation of the catheter to prevent its dislocation, the creation of a sufficiently high concentration of ozonated solution in the efferent lymphatic vessels closest to the pathological focus and lymph nodes.

The technical result is achieved by the fact that in the method of treating purulent-necrotic lesions of the foot in patients with the ischemic form of diabetic foot syndrome, balloon angioplasty of the arteries of the affected lower limb is performed, the next day after balloon angioplasty, direct antegrade endolymphatic therapy is performed with the introduction of ozonated saline solution into the lymphatic catheter . To do this, a catheter is installed along the front surface in the middle third of the leg and 10 ml of physiological solution is injected at a rate of 0.3-0.4 ml/min. Treatment lasts 5 days - one session per day.

Ozonated saline solution is an isotonic sterile sodium chloride solution with an ozone concentration of 3.0-6.0 mg/l.

In the X-ray operating room, for the purpose of performing balloon angioplasty, the femoral approach of the affected or contralateral limb was used. A 0.5% novocaine solution was used to anesthetize the arterial puncture site. For angiography, contrast agents were used - Ioversol, Iohexol. Vasodilation of the arteries below the inguinal fold was performed using an antegrade approach using a balloon catheter, the choice of which depended on the length of the affected area. For multilevel lesions, sequential angioplasties of the affected arteries were performed. The criterion for the success of the procedure was a good angiographic result during X-ray control.

Contraindications for balloon angioplasty of the arteries of the lower extremity are standard for all endovascular interventions.

Direct endolymphatic ozone therapy began the day after balloon angioplasty of the arteries of the affected lower limb. Ozone therapy consisted of the use of an ozonized isotonic sterile sodium chloride solution. The resulting ozone-oxygen mixture was saturated with a sterile isotonic sodium chloride solution. A freshly prepared solution with an ozone concentration of 3.0-6.0 mg/l was then injected endolymphatically in a volume of 10 ml at a rate of 0.3-0.4 ml per minute using a syringe pump. The course of treatment was 5 days - one session per day.

The lymphatic collector was punctured and catheterized in the area of the middle third of the anterior surface of the leg using a lymphangiographic catheter.

Due to the need to expose the lymphatic vessel in the middle third of the leg, 10-15 minutes before surgery, 1-2 ml of lymphotropic dye (1% aqueous solution of methylene blue) was injected into the first or second interdigital space of the foot. A 0.5-1% solution of novocaine was used to anesthetize the incision area. A skin incision was made along the anteromedial surface of the leg in the middle third; after dividing the soft tissues, the lymphatic duct was isolated under visual control. The duct was punctured and catheterized, and a catheter was installed in the antegrade direction. The criteria for assessing the correct placement of the catheter were, when introducing a solution of novocaine into the catheter, an objective assessment by light palpation of the lymphatic drainage pathways, subjective assessment - the appearance in the patient of sensations in the groin area on the side of the standing catheter. The catheter was fixed in the wound. The wound was sutured. The catheter was fixed to the skin with adhesive tape. The outer end of the catheter was connected to a syringe pump to administer ozonated saline solution. After completing the course of endolymphatic ozone therapy, the catheter was removed from the wound and an aseptic dressing was applied. The sutures from the skin wound were removed after 3-5 days.

Contraindications to direct endolymphatic ozone therapy: infectious lesions at the site of the intended puncture of the lymphatic vessel, allergy to ozone, coagulation system disorders, bleeding from organs, thrombocytopenia, hyperthyroidism, myocardial infarction.

The procedure for placing an endolymphatic catheter into the lymphatic vessels located along the anteromedial surface of the leg in the middle third is performed in a “standard” operating room and does not require special equipment to enlarge the objects of the surgical wound.

Low mobility of the skin and soft tissues of the anteromedial surface of the leg in the middle third due to fixation to the periosteum of the tibia and the absence of muscle masses in this area allows one to avoid dislocation and keep the catheter fixed in the surgical wound during the course of ozone therapy.

After revascularization of the affected arteries of the lower limb, direct antegrade endolymphatic ozone therapy the next day allows you to sanitize the lymphatic pathways of transport of bacteria from the purulent-necrotic lesion of the foot and their toxins, create a sufficiently high concentration of the ozonized solution in the lymph nodes closest to the pathological focus, because the development of reperfusion syndrome can be observed already from the second day after reconstructive surgery on the main arteries of the lower limb.

The proposed complex method, including balloon angioplasty of the arteries of the lower extremity and direct antegrade endolymphatic ozone therapy, makes it possible to potentiate the effects of limb revascularization in patients with ischemia due to diabetes mellitus with an effect on the spread of infection in the presence of purulent-necrotic lesions on the foot: the pain syndrome is reduced, the degree of bacterial contamination, the leukocyte formula of peripheral blood improves. the volume and severity of subsequent surgical intervention for a purulent-necrotic lesion are reduced. The complex method used does not statistically significantly lead to an increase in the duration of hospital treatment.

The main influence of the proposed method is aimed at the combining effect of endovascular correction of blood flow in the ischemic lower limb and direct endolymphatic ozone therapy to reduce the risk of generalization of the infectious process on the foot after revascularization surgery (development of reperfusion syndrome) and preparing the patient for subsequent sanitation of a purulent-necrotic lesion of the foot.

The method increases the likelihood of performing economical resections and amputations while preserving a weight-bearing limb and can be used in patients at high risk of lower limb amputation.

The method was introduced into the work of the purulent surgery department of the BUZ VOKB No. 1. 20 patients with purulent-necrotic complications of diabetic foot syndrome were treated: degree of foot damage according to Wagner 2-4, ABI less than 0.7. The control group consisted of 25 patients, according to a retrospective analysis of inpatient charts, who underwent complex treatment without the use of endovascular and endolymphatic interventions. The groups are comparable in basic parameters.

Assessment of pain syndrome using a 4-point verbal pain rating scale (Ohnhaus E.E., Adler R., 1975) after treatment using the proposed method revealed the absence of patients with severe pain in the affected lower limb, a decrease from 60% to 10% of patients with moderate pain, an increase to 35% of patients with mild pain that does not require the use of analgesics, an increase to 55% of patients with no pain. In the control group, upon discharge, patients with severe pain in the affected lower limb were also not identified; the number of patients with moderate pain syndrome decreased from 68% to 20%; the number of patients with mild pain syndrome (not requiring the use of analgesics or with episodic application), an increase to 28% in the number of patients with no pain.

The high efficiency of the complex method was confirmed in comparison with the control group: the severity of operations aimed at eliminating the purulent-necrotic lesion of the foot was reduced by 57.3%, the order of sowing wound discharge after treatment was reduced by 33.5%, the content of peripheral blood leukocytes was reduced by 29%. after treatment with an increase in the level of lymphocytes, with normalization of the neutrophil shift index, which may indicate the active influence of the proposed method on the course of the purulent-necrotic process of the foot.

Clinical example

Patient N., 55 years old, diagnosis: diabetes mellitus, type 2. Diabetic angiopathy of the lower extremities. Diabetic distal sensory polyneuropathy of the lower extremities. Atherosclerosis of the vessels of the lower extremities, grade 3-4 ischemia. Dry necrosis in the area of the nail phalanx of 1 point of the right foot.

Suffering from diabetes mellitus for 6 years. She was admitted as an emergency with complaints of constant aching pain in the right foot, decreasing when the limb is lowered down, coldness of the right foot, the presence of a dark-colored skin area in the area of the nail phalanx 1 p.

On objective examination: there is no edema or hyperemia of the right lower limb, the skin is cool to the touch, pale, with a cyanotic tint in the distal part of the foot. An area of dry soft tissue necrosis 3x2 cm in the area of the nail phalanx of the 1st finger. There is no fluctuation of soft tissues. Pulsation on the dorsum of the foot and in the popliteal region is not palpable, but is preserved in the groin area.

Doppler ultrasound of the arteries of the right lower extremity shows occlusion of the arteries of the right leg in the subcompensation stage, ABI on the PBBA 0.59, on the SBBA 0.49.

X-ray of the right foot - signs of osteomyelitis of the distal head of the 5th metatarsal bone, heel spur.

Bacteriological examination upon admission - Shewanella putrefaciens 10 ⁶ CFU/ml, Staphylococcus aureus 10 ² CFU/ml.

During arteriography of the right lower extremity, the OA, IPA, VPA, BOTH, GBA, SFA are contrasted (irregularity of contours throughout). The popliteal artery is contrasted, stenoses are 50-70%. In the area of the trifurcation orifice there is 90% stenosis. PBBA is contrasted, SBBA and MBA are not contrasted.

Against the background of complex conservative therapy, an increase in the phenomena of ischemia of the lower extremity was noted - necrosis of soft tissues in the area of the nail phalanx of the 1st finger 3x2 cm, the formation of dry necrosis of 4-5 fingers, necrosis of soft tissues 4x2.5 cm at the base of the 5th finger on dorsum of the foot.

The patient underwent balloon angioplasty of the popliteal artery and arteries of the right leg. A satisfactory angiographic result was obtained. The next day after revascularization, an endolymphatic catheter was placed in the middle third of the right leg with the introduction of ozonated saline solution with an ozone concentration of 3.0-6.0 mg/l in a volume of 10 ml at a rate of 0.3-0.4 ml per minute. using a syringe pump.

In the postoperative period, the patient noted a decrease in pain and a feeling of warming in the right foot. Areas of dry necrosis in the area of the toes and on the dorsum of the right foot did not increase, and a clear line of demarcation was formed. After 5 days, the patient underwent resection of the right foot according to Chopart due to tissue deficiency after excision of necrosis within viable tissue.

10 days after foot resection, the patient was discharged in satisfactory condition under the supervision of a surgeon at her place of residence. Upon discharge: periodic pain in the stump of the right foot when walking, weight-bearing ability of the lower limb was preserved. The postoperative wound heals by primary intention, with isolated foci of superficial marginal necrosis, edema and hyperemia of the stump of the right foot. The postoperative wound in the middle third of the leg heals by primary intention, without perifocal inflammation. Bacteriological examination at discharge - no growth of microflora was detected.

Claims (2)

1. A method for the treatment of purulent-necrotic lesions of the feet in patients with the ischemic form of diabetic foot syndrome, which consists of performing balloon angioplasty of the arteries of the affected lower limb and performing direct antegrade endolymphatic therapy the next day with the introduction of ozonated saline solution into a lymphatic catheter installed along the anterior surface in the middle third of the leg, while 10 ml of ozonized saline solution is administered at a rate of 0.3-0.4 ml/min, treatment lasts 5 days - one session per day. 2. The method according to claim 1, characterized in that the ozonated physiological solution is an isotonic sterile solution of sodium chloride with an ozone concentration of 3.0-6.0 mg/l.