A traditional Chinese medicine composition for treating diabetic foot, a preparation method and application thereof

Abstract

This invention provides a traditional Chinese medicine composition, preparation method, and application for treating diabetic foot, belonging to the field of diabetic foot treatment technology. This invention prepares a traditional Chinese medicine composition for diabetic foot, which uses peach kernel, safflower, angelica, chuanxiong rhizome, mugwort leaf, sappanwood, frankincense, myrrh, *Luffa cylindrica*, *Lycopodium clavatum*, *Clematis chinensis*, and mulberry twig in combination. This composition exerts the effects of promoting blood circulation, removing blood stasis, clearing the meridians, relieving pain, and nourishing blood. It can effectively alleviate limb pain and numbness symptoms in diabetic foot patients, improve skin color and nutritional status, reduce the incidence of ulcers, and significantly reduce TCSS scores, effectively improving peripheral neuropathy in diabetic foot patients. Furthermore, it can prevent diabetic foot ulcers in patients who have not yet developed them, reducing the incidence of foot ulcers. This invention uses a combination of oral administration and immersion to treat diabetic foot, which is simple to operate, low in cost, and has better therapeutic effects compared to Western medicine treatments.

Description

Technical Field

[0001] This invention relates to the field of diabetic foot treatment technology, and in particular to a traditional Chinese medicine composition, preparation method and application for treating diabetic foot. Background Technology

[0002] Diabetes is a metabolic disease characterized by high blood sugar. It is one of the four major chronic diseases that pose the greatest threat to human health. In its later stages, it is often complicated by neurological and vascular lesions, involving multiple tissues and organs, especially the feet.

[0003] Diabetic foot is a disease caused by peripheral neuropathy and / or vascular disease in diabetic patients, resulting in lower limb infection, ulceration, and / or deep tissue destruction. It is a serious complication of diabetes, with high rates of disability and mortality, and is a leading cause of amputation in diabetic patients. Furthermore, diabetic foot is the second most expensive diabetes-related complication, placing a significant financial burden on patients. In recent years, with the rapid increase in the incidence of type 2 diabetes, the incidence of diabetic foot has also risen, making high rates of diabetic foot a serious public health problem.

[0004] Diabetic foot is classified into six grades according to the Wagner classification, with grade 0 indicating that the patient has risk factors for foot ulcers but currently has no ulcers. Wagner grade 0 diabetic foot is also known as high-risk diabetic foot; at this stage, although the patient's foot is not ulcerated, peripheral neuropathy and / or peripheral vascular disease, and foot deformities are already present. In addition, diabetic patients with a history of foot ulcers or amputation (toe) who are currently asymptomatic are also considered to have high-risk diabetic foot. According to the guidelines of the International Working Group on Diabetic Foot (IWGDF), strengthening the screening and management of high-risk diabetic foot is key to preventing diabetic foot.

[0005] Peripheral vascular and neuropathy are important factors affecting the prognosis of diabetic foot. Early examination can clarify the patient's neuropathy and vascular lesions, and intervention measures can be taken according to the condition. This can improve the peripheral vascular and neuropathy and reduce the risk of diabetic foot ulcers. However, currently, diabetic patients lack knowledge of foot care, have poor foot care practices, and have low awareness, management, and control rates of diabetic foot, which is very detrimental to the prevention of diabetic foot. Therefore, strengthening the prevention and management of diabetic foot is an important measure to reduce the incidence of diabetic foot ulcers.

[0006] Regularly checking and assessing foot condition is the first step in the prevention and treatment of diabetic foot, identifying whether patients have high-risk factors for diabetic foot through screening. The International Diabetes Center proposed in 2011 that 45%–85% of foot ulcers are preventable through early diagnosis and active management. Foot management is the second step in the prevention and treatment of diabetic foot. Currently, foot management measures mainly include medication guidance, foot skin care, health education, and daily care. However, the prevention and treatment of high-risk diabetic foot faces challenges, including a lack of foot management knowledge and weak awareness of foot protection among patients, a lack of early prevention awareness, and psychological damage due to uncertainty about the disease.

[0007] For the treatment of high-risk diabetic foot, Western medicine currently mainly uses conventional drugs such as mecobalamin, alprostadil, and insulin to treat the underlying disease, but the effect is limited, and no more effective prevention plan has been proposed to date.

[0008] High-risk diabetic foot falls under the categories of "Xiao Ke" and "Mai Bi" in Traditional Chinese Medicine (TCM). TCM classifies high-risk diabetic foot into various syndromes, primarily including meridian obstruction syndrome, cold-induced meridian obstruction syndrome, damp-heat meridian obstruction syndrome, and qi deficiency and blood stasis syndrome. Diabetic foot is caused by long-term yin deficiency leading to qi and blood stagnation, compounded by phlegm and dampness, resulting in disharmony of the meridians and ultimately affecting the limbs. Current treatment methods mainly include oral TCM decoctions, herbal foot baths, acupressure, herbal plasters, and moxibustion. Oral TCM decoctions primarily consist of blood-activating and stasis-removing herbs. Among local treatments, herbal foot baths are widely used and well-accepted by patients due to their flexible formulation, fewer herbs, larger dosages, significant efficacy, and ease of use.

[0009] Early intervention is especially important for high-risk diabetic foot, so there is an urgent need to find a convenient and effective way to intervene in diabetic foot. Summary of the Invention

[0010] The purpose of this invention is to provide a traditional Chinese medicine composition, preparation method and application for treating diabetic foot. This traditional Chinese medicine composition can effectively relieve the symptoms of limb pain and numbness in diabetic foot patients, improve skin color and nutritional status, reduce the incidence of ulcers, and significantly reduce the TCSS score, thus effectively improving peripheral neuropathy in diabetic foot patients.

[0011] To achieve the above-mentioned objectives, the present invention provides the following technical solution: This invention provides a traditional Chinese medicine composition for treating diabetic foot, comprising the following raw materials in parts by weight: Peach kernel 1-10 parts, safflower 5-15 parts, angelica 10-20 parts, chuanxiong 10-20 parts, mugwort 5-15 parts, sappanwood 5-15 parts, frankincense 1-5 parts, myrrh 1-5 parts, luffa cylindrica 5-15 parts, lycopodium clavatum 5-15 parts, clematis chinensis 5-15 parts, mulberry twig 5-15 parts.

[0012] Preferably, the traditional Chinese medicine composition for treating diabetic foot is composed of the following raw materials in parts by weight: Peach kernel 4-8 parts, safflower 7-10 parts, angelica 10-15 parts, chuanxiong 10-15 parts, mugwort 7-10 parts, sappanwood 7-10 parts, frankincense 2-3 parts, myrrh 2-3 parts, luffa cylindrica 7-10 parts, lycopodium clavatum 7-10 parts, clematis chinensis 7-10 parts, mulberry twig 7-10 parts.

[0013] Preferably, the traditional Chinese medicine composition for treating diabetic foot is composed of the following raw materials in parts by weight: Peach kernel 6 parts, safflower 9 parts, angelica 15 parts, chuanxiong 15 parts, mugwort 9 parts, sappanwood 9 parts, frankincense 3 parts, myrrh 3 parts, luffa cylindrica 9 parts, lycopodium clavatum 9 parts, clematis 9 parts, mulberry twig 9 parts.

[0014] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition for treating diabetic foot, comprising the following steps: (1) Peach kernel, safflower, angelica, chuanxiong, mugwort, sappanwood, frankincense, myrrh, luffa cylindrica, lycopodium clavatum, clematis chinensis and mulberry twig are mixed in proportion to obtain a mixture; (2) The mixture from step (1) and water are decocted for the first time at a mass ratio of 1:10~20. The dregs are filtered and the water is decocted for the second time at a mass ratio of 1:4~6. The two decoctions are combined to obtain a traditional Chinese medicine composition for treating diabetic foot.

[0015] The present invention also provides the application of the above-mentioned traditional Chinese medicine composition for treating diabetic foot in the preparation of a drug for treating diabetic foot.

[0016] The beneficial effects of this invention compared to the prior art are as follows: (1) The present invention provides a traditional Chinese medicine composition for diabetic foot. The traditional Chinese medicine composition is made by combining peach kernel, safflower, angelica, chuanxiong, mugwort, sappanwood, frankincense, myrrh, luffa, lycopodium, clematis, and mulberry twig. It can promote blood circulation, remove blood stasis, unblock collaterals and relieve pain, and nourish blood and relieve pain. It can effectively reduce the symptoms of limb pain and numbness in diabetic foot patients, improve skin color and nutritional status, reduce the incidence of ulcers, and significantly reduce the TCSS score. It can effectively improve the peripheral neuropathy in diabetic foot patients.

[0017] (2) The traditional Chinese medicine composition of the present invention for the treatment of diabetic foot has good safety and no serious adverse reactions have occurred. It can prevent diabetic foot ulcers in patients who have not yet developed them in the early stage, thereby reducing the incidence of foot ulcers. Furthermore, the present invention adopts a combination of oral administration and immersion to treat diabetic foot, which is simple to operate and low in cost, but has a better therapeutic effect compared with Western medicine treatment. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 This is the TCM syndrome scoring table for Experimental Example 1 of the present invention. Detailed Implementation

[0020] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0021] It should be understood that the terminology used in this invention is merely for describing particular embodiments and is not intended to limit the invention. Furthermore, with respect to numerical ranges in this invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Every smaller range between any stated value or intermediate value within a stated range, and any other stated value or intermediate value within said range, is also included in this invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0022] Unless otherwise stated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. While only preferred methods and materials have been described herein, any methods and materials similar or equivalent to those described herein may be used in the implementation or testing of this invention. All references to this specification are incorporated by way of citation to disclose and describe methods and / or materials associated with those references. In the event of any conflict with any incorporated reference, the content of this specification shall prevail.

[0023] Various modifications and variations can be made to the specific embodiments described in this specification without departing from the scope or spirit of the invention, as will be apparent to those skilled in the art. Other embodiments derived from this specification will also be apparent to those skilled in the art. This specification and embodiments are merely exemplary.

[0024] The terms “include,” “including,” “have,” “contain,” etc., used in this article are all open-ended terms, meaning that they include but are not limited to.

[0025] Example 1 Example 1 of this invention provides a method for preparing a traditional Chinese medicine composition for treating diabetic foot, the specific steps of which are as follows: Take 6g of peach kernel, 9g of safflower, 15g of angelica, 15g of chuanxiong rhizome, 9g of mugwort leaf, 9g of sappanwood, 3g of frankincense, 3g of myrrh, 9g of luffa fruit, 9g of lycopodium, 9g of clematis root, and 9g of mulberry twig. Add 1500mL of water to the above herbs and decoct for the first time to obtain 250mL of juice. Add another 500mL of water and decoct for the second time to obtain 150mL of juice. Combine the two juices to obtain an oral preparation.

[0026] Continue to boil the dregs with water until the volume reaches 3000 mL.

[0027] Example 2 Example 2 of this invention provides a method for preparing a traditional Chinese medicine composition for treating diabetic foot, the specific steps of which are as follows: Take 10g of peach kernel, 7g of safflower, 20g of angelica, 10g of chuanxiong rhizome, 15g of mugwort leaf, 7g of sappanwood, 2g of frankincense, 3g of myrrh, 13g of luffa fruit, 6g of lycopodium, 8g of clematis root, and 10g of mulberry twig. Add 1200mL of water to the above herbs and decoct for the first time to obtain 250mL of juice. Add another 600mL of water and decoct for the second time to obtain 150mL of juice. Combine the two juices to obtain an oral preparation.

[0028] Continue to boil the dregs with water until the volume reaches 3000 mL.

[0029] Example 3 Example 2 of this invention provides a method for preparing a traditional Chinese medicine composition for treating diabetic foot, the specific steps of which are as follows: Take 8g of peach kernel, 10g of safflower, 17g of angelica, 15g of chuanxiong, 10g of mugwort, 10g of sappanwood, 3g of frankincense, 2g of myrrh, 10g of luffa fruit, 8g of lycopodium, 10g of clematis root, and 8g of mulberry twig. Add 1200mL of water to the above herbs and decoct for the first time to obtain 250mL of juice. Add another 500mL of water and decoct for the second time to obtain 150mL of juice. Combine the two juices to obtain an oral preparation.

[0030] Continue to boil the dregs with water until the volume reaches 3000 mL.

[0031] Example 4 Example 2 of this invention provides a method for preparing a traditional Chinese medicine composition for treating diabetic foot, the specific steps of which are as follows: Take 4g of peach kernel, 15g of safflower, 10g of angelica, 20g of chuanxiong, 7g of mugwort, 15g of sappanwood, 5g of frankincense, 3g of myrrh, 7g of luffa, 12g of lycopodium, 7g of clematis, and 15g of mulberry twig. Add 1200mL of water to the above herbs and decoct for the first time to obtain 250mL of juice. Add another 600mL of water and decoct for the second time to obtain 150mL of juice. Combine the two juices to obtain an oral preparation.

[0032] Continue to boil the dregs with water until the volume reaches 3000 mL.

[0033] Experimental Example 1 Test Example 1 of this invention tested the therapeutic effect of the traditional Chinese medicine composition prepared in Example 1 for treating diabetic foot. The specific steps are as follows: 1. Clinical case selection: (1) Diagnostic criteria Classification was performed according to the Wagner classification of diabetic foot (Meggitt, 1976); Grade 0: There are risk factors for ulceration, but there are currently no ulcers on the feet; Grade I: Superficial ulcer without infection; Grade II: Deep ulcer with soft tissue inflammation, but no abscess or bone infection; Grade III: Deep ulcer, accompanied by abscess or osteomyelitis; Grade IV: Localized gangrene (toes, heels, or dorsum of the forefoot). Grade V: Gangrene of the entire foot.

[0034] Referring to the Wagner classification of diabetic foot grade 0 and the 2015 International Diabetes Foot Working Group's guidelines for the prevention of diabetic foot, a diagnosis of high-risk diabetic foot should meet at least the first criterion and one of the remaining four criteria: 1) A patient diagnosed with diabetes who currently has no foot ulcers but is at risk of developing foot ulcers. There are no open lesions on the skin of the foot, but one of the symptoms of neurological or vascular disease is present: numbness, dulled or lost sensation, tingling or burning pain in the lower extremities, with pain worsening at night; insufficient blood supply to the extremities, intermittent limping, weakened or absent dorsalis pedis pulse, cold lower extremity temperature, and purplish-brown skin color; with or without foot or toe deformities.

[0035] 2) Positive results in nylon monofilament test, tuning fork test, or pressure tingling sensation test.

[0036] 3) Neurophysiological testing indicated abnormalities in motor or sensory conduction in the lower limbs.

[0037] 4) Ankle-brachial index (ABI) > 0.90.

[0038] 5) A history of diabetic foot ulcers or foot deformities.

[0039] Traditional Chinese Medicine (TCM) diagnostic criteria for high-risk diabetic foot: Patients meeting the criteria for diabetic foot with blood stasis as defined in the chapter on diabetic foot in the 2007 "Guidelines for the Prevention and Treatment of Diabetes in Traditional Chinese Medicine". Blood stasis type: numbness and pain in the affected limb, like needle pricks, especially at night, with a fixed location of pain, dark red skin or purple spots on the foot, or intermittent claudication; or slow growth of granulation tissue in the affected foot, with the redness and swelling of the surrounding tissue having subsided; local skin temperature is cool; the tongue is purplish or has ecchymosis, with a thin white or little coating, a thready and hesitant pulse, and a weakened or absent pulse at the fuyang point.

[0040] (2) Inclusion criteria: a. Meets the diagnostic criteria for high-risk diabetic foot; b. Meets the Wagner Class 0 grading criteria for diabetic foot; c. Meets the diagnostic criteria for the above-mentioned high-risk diabetic foot vascular obstruction type; d. Age 45-80 years old; e. Those who sign the informed consent form.

[0041] Only those who meet all of the above criteria can be included.

[0042] (3) Exclusion criteria: a. Age under 45 or over 80.

[0043] b. Lower limb vascular and nerve damage caused by other diseases.

[0044] c. Patients with severe cardiac, hepatic, or renal impairment, bone marrow hematopoietic function, or other severe abnormalities in other systems.

[0045] d. Anemia and platelet count <100X10~9 / L.

[0046] e. Individuals who are allergic to any of the medications in the treatment plan and are therefore unsuitable for this treatment plan.

[0047] f. Those who do not meet the above inclusion criteria.

[0048] Those that meet one of the above criteria will be excluded.

[0049] (4) Exclusion and dropout criteria for cases a. If allergic reactions such as itching, blisters, redness, or swelling around the wound occur during treatment, or if systemic adverse events occur, the trial should be stopped according to the doctor's judgment; b. If the patient's condition worsens during the trial and develops into Wagner grade II or above, the clinical trial for that case will be terminated. c. Subjects with poor compliance who are unwilling to continue the clinical trial, voluntarily change medications midway, or add Chinese or Western medicines prohibited by this protocol may withdraw from the clinical trial for that case; d. Those who fail to take medication as prescribed, making it impossible to determine the efficacy, or whose data is incomplete, thus affecting the assessment of efficacy or safety.

[0050] (5) Ethical requirements The clinical trial protocol was designed in accordance with ethical requirements.

[0051] Subject privacy protection: Only researchers involved in the clinical trial will have access to and will keep confidential the subjects' personal medical records. Data processing will employ anonymization, omitting personally identifiable information of the subjects.

[0052] Informed consent process: The physicians participating in the clinical trial provide the subjects with detailed information about the trial, including its purpose, nature, potential benefits and risks, alternative treatment options, and the subjects' rights and obligations in accordance with the Declaration of Helsinki, ensuring the subjects understand and consent. Clinical trials only proceed after the subjects have voluntarily signed an informed consent form.

[0053] This invention was approved by the Ethics Committee of Beicai Community Health Service Center in Pudong New Area, Shanghai on May 6, 2021, and its implementation was approved.

[0054] 2. Clinical trial design (1) Group processing The enrolled patients were divided into two groups: a TCM treatment group for high-risk diabetic foot and a Western medicine control group.

[0055] (2) Case estimation: According to domestic and international literature reports, the lifetime risk of foot ulcers in patients with high-risk diabetic foot can be as high as 25%. It is envisioned that after intervention with this invention, the incidence of foot ulcers in high-risk diabetic foot can be reduced to 5%. With parameters a = 0.05 and p = 0.1, this invention divides patients into a treatment group and a control group, with a ratio of 1:1. Then, U... α =1.65, U β =1.28, π0=25%, δ=20%.

[0056] N = π0 (1 - π0) [(U] α +U β ) / δ] 2 =0.25(1-0.25)[(1.65+1.28) / 0.20]² =0.25*0.75*214.6=40.24 To control the loss to follow-up rate to less than 10%, the estimated sample size for each group was no less than 45 cases, with a planned enrollment of 90 cases. The TCM treatment group for high-risk diabetic foot and the routine Western medicine control group each had 45 patients.

[0057] 3. Treatment Plan (1) Scheme selection: a. Control group: Basic treatment + oral mecobalamin tablets and enteric-coated aspirin tablets (Mecobalamin tablets: National Drug Approval Number: H20080290, produced by Jiangsu Sihuan Biopharmaceutical Co., Ltd., 1 tablet 0.5mg / time, 3 times / day, orally after meals. Enteric-coated aspirin tablets: produced by Bayer Healthcare GmbH, Germany, Approval Number: National Drug Approval Number J20130078, Dosage and administration: 100mg once daily, orally after meals).

[0058] b. Treatment group: Basic treatment + the traditional Chinese medicine composition for treating diabetic foot prepared in Example 1. The oral dosage is taken twice a day, morning and evening. The soaking solution is used to soak the affected foot in water at 37-40°C for 30 minutes each time, once a day.

[0059] (2) Basic treatment a. Refer to the "Chinese Guidelines for the Prevention and Treatment of Diabetes": Subjects were required to follow a low-salt, low-fat diabetic diet and abstain from smoking and alcohol.

[0060] b. Blood sugar control: Depending on the condition, administer oral hypoglycemic agents or subcutaneous insulin injections to control blood sugar.

[0061] c. Blood pressure control: Patients with hypertension should take antihypertensive medication regularly to keep their blood pressure within the normal range.

[0062] d. Control blood lipids: For those with high blood lipids, oral lipid-lowering drugs are used for treatment.

[0063] (3) Observation period: 6 months (treatment ends after 3 months, and follow-up continues for 3 months).

[0064] (4) Evaluation indicators: 1) Efficiency The evaluation was conducted with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs (Trial)" formulated by the Ministry of Health in 2002. The evaluation criteria are shown below. The treatment results of the TCM treatment group and the conventional Western medicine control group for high-risk diabetic foot are shown in Table 1.

[0065] Therapeutic effect index (n) = (Pre-treatment score - Post-treatment score) / Pre-treatment score x 100% Clinical cure: TCM symptoms and signs disappear or basically disappear, n>90%.

[0066] Significant effect: TCM symptoms and signs improved significantly, syndrome scores decreased, 70% < n < 90%.

[0067] Effective: Improvement in TCM symptoms and signs, reduction in syndrome scores, 30% < n < 70%.

[0068] Ineffective: No significant improvement or even worsening of TCM symptoms and signs, and a decrease in syndrome score, n<30%.

[0069] Table 1. Treatment results of the TCM treatment group and the Western medicine routine control group for high-risk diabetic foot.

[0070] As shown in Table 1, the traditional Chinese medicine composition of the present invention for treating diabetic foot has a good therapeutic effect on diabetic foot, and the therapeutic effect is better than that of conventional Western medicine treatment.

[0071] 2) Traditional Chinese Medicine Syndrome Scoring: Referring to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs" (2002 edition), symptoms and signs were categorized into four levels: normal, mild, moderate, and severe, based on their presence and severity. The scores for primary symptoms and signs, from normal to severe, were 0, 2, 4, and 6 points respectively; the scores for secondary symptoms and signs, from normal to severe, were 0, 1, 2, and 3 points respectively (see...). Figure 1 The results are shown in Table 2.

[0072] Table 2. TCM syndrome scores of the TCM treatment group and the Western medicine routine control group for high-risk diabetic foot.

[0073] Note: # indicates that compared with the group before treatment, P<0.05; * indicates that compared with the control group at the same time point, P<0.05.

[0074] As shown in Table 2, both the traditional Chinese medicine treatment group and the Western medicine control group can effectively improve limb pain, numbness, skin color, and skin nutrition in diabetic foot, and the treatment group of the present invention is superior to the control group.

[0075] 3) Toronto Clinical Social Responsibility Scale (TCSS) The Toronto Clinical Scoring System (TCSS) is a scoring system developed in 2001 by diabetes and neuropathy experts at the University of Toronto. The TCSS score includes symptom scores, reflex scores, and sensory test scores (as shown in Table 3). The TCSS score results of the high-risk diabetic foot TCM treatment group and the Western medicine routine control group are shown in Table 4.

[0076]

[0077] The TCSS score is calculated as follows: Symptom score: present = 1; absent = 0; Reflex score: absent = 2; weakened = 1; normal = 0; Sensory assessment score: abnormal = 1; normal = 0. The total TCSS score is 19 points, with 6 points allocated to symptom assessment, 8 points to lower limb reflex assessment, and 5 points to big toe sensory assessment. The lowest score is 0, and the highest score is 19. This TCSS score was obtained by the research team through questioning or measurement of patients. A higher score indicates more severe symptoms. The appropriate cutoff point for diagnosing diabetic foot peripheral neuropathy using the TCSS score is a TCSS score greater than 6.

[0078] Table 4. TCSS scores of the TCM treatment group and the Western medicine routine control group for high-risk diabetic foot.

[0079] Note: # indicates a comparison with pre-treatment levels in this group, P<0.05; * indicates a comparison with the control group at the same time point, P<0.05. The treatment group showed a significant decrease in TCSS scores after treatment compared to pre-treatment levels (P<0.001); there was no significant difference in TCSS scores before and after treatment in the control group (P=0.068); the TCSS score in the treatment group was significantly lower than that in the control group after treatment (P=0.021<0.05).

[0080] As shown in Table 4, the Diabetic Foot Formula can effectively improve the TCSS score of high-risk diabetic feet and reduce symptoms such as foot pain, numbness, tingling, and weakness caused by diabetic foot.

[0081] 4) Ulcer incidence rate: The ulcer incidence rate in each group = the number of cases with ulcers during the observation period to the end of the observation period / the actual number of cases in each group. The results are shown in Table 5.

[0082] Table 5. Incidence of ulcers in the TCM treatment group and the routine Western medicine control group at high risk of diabetes.

[0083] As shown in Table 5, the number of patients developing foot ulcers was slightly lower in the group treated with the traditional Chinese medicine composition of this invention than in the group treated with Western medicine, but there was no statistically significant difference in the incidence of foot ulcers between the two groups (P=0.548>0.05). Therefore, compared with Western medicine treatment, the traditional Chinese medicine composition of this invention can effectively improve the condition of foot ulcers in patients with diabetic foot and reduce the incidence of foot ulcers.

[0084] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating diabetic foot, characterized in that, Composed of the following raw materials in parts by weight: Peach kernel 1-10 parts, safflower 5-15 parts, angelica 10-20 parts, chuanxiong 10-20 parts, mugwort 5-15 parts, sappanwood 5-15 parts, frankincense 1-5 parts, myrrh 1-5 parts, luffa cylindrica 5-15 parts, lycopodium clavatum 5-15 parts, clematis chinensis 5-15 parts, mulberry twig 5-15 parts.

2. The traditional Chinese medicine composition for treating diabetic foot according to claim 1, characterized in that, Composed of the following raw materials in parts by weight: Peach kernel 4-8 parts, safflower 7-10 parts, angelica 10-15 parts, chuanxiong 10-15 parts, mugwort 7-10 parts, sappanwood 7-10 parts, frankincense 2-3 parts, myrrh 2-3 parts, luffa cylindrica 7-10 parts, lycopodium clavatum 7-10 parts, clematis chinensis 7-10 parts, mulberry twig 7-10 parts.

3. The traditional Chinese medicine composition for treating diabetic foot according to claim 2, characterized in that, Composed of the following raw materials in parts by weight: Peach kernel 6 parts, safflower 9 parts, angelica 15 parts, chuanxiong 15 parts, mugwort 9 parts, sappanwood 9 parts, frankincense 3 parts, myrrh 3 parts, luffa cylindrica 9 parts, lycopodium clavatum 9 parts, clematis 9 parts, mulberry twig 9 parts.

4. A method for preparing a traditional Chinese medicine composition for treating diabetic foot as described in any one of claims 1 to 3, characterized in that, Includes the following steps: (1) Peach kernel, safflower, angelica, chuanxiong, mugwort, sappanwood, frankincense, myrrh, luffa cylindrica, lycopodium clavatum, clematis chinensis and mulberry twig are mixed in proportion to obtain a mixture; (2) The mixture from step (1) and water are decocted for the first time at a mass ratio of 1:10~20. The dregs are filtered and the water is decocted for the second time at a mass ratio of 1:4~6. The two decoctions are combined to obtain a traditional Chinese medicine composition for treating diabetic foot.

5. The use of the traditional Chinese medicine composition for treating diabetic foot according to any one of claims 1 to 3 in the preparation of a medicament for treating diabetic foot.

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