Management of Diabetic Foot Ulcers using comprehensive ayurvedic treatment protocol.

Phase 2/3

Not yet recruiting

Conditions: Type 2 diabetes mellitus with other specified complications. Ayurveda Condition: DUSHTAVRANAH, (2) ICD-10 Condition: E106||Type 1 diabetes mellitus with other specified complications. Ayurveda Condition: DUSHTAVRANAH,

Registration Number: CTRI/2022/09/045716

Lead Sponsor: Ayurveda Mahavidyalaya College and Hospital

Brief Summary: Diabetes Mellitus has now become a global pandemic due to erratic food habits of the people and also due to the present day sedentary lifestyle. India has an estimated 77 million people with diabetes, which makes it the second most affected country in the world, after China. As per the WHO, Diabetes is a major cause of blindness, kidney failure, heart attacks, stroke and foot ulceration leading to lower limb amputation. Wound/ulcer is the breach in the continuity of the skin which results in localized cellular and molecular changes. Non healing ulcer or dushta vrana is the one which has combination of signs and symptoms which are otherwise not seen in a healthy healing wound and which results in excess foul-smelling discharge, pain, slough etc due to various internal and external factors. Diabetes mellitus is one such systemic factor which can result in an non healing ulcer and make the diabetic patient prone to develop various complications. Among all these complications related to Diabetes mellitus, foot ulceration is the most common, affecting approximately 15% of diabetic patients during their lifetime. Between 0.03% and 1.5% of patients with diabetic foot, require an amputation. It has been estimated that, globally, a lower limb (or part of a lower limb), is lost to amputation every 30 seconds as a consequence of diabetes. This is because of multiple pathologies like micro angiopathy of the foot, neuropathy, association with atherosclerosis etc and also due to various other factors like improper diabetic medication, improper diet, barefoot walking, low socio-economic conditions, minor un-noticed trauma and also lack of awareness regarding foot care which patients suffering from diabetes should follow. All these factors lead to formation of diabetic foot ulcer which makes the life of the patient miserable with its nonhealing nature, foul smell, pain, repeated superimposed infections etc and also can lead to gangrenous changes in the affected foot finally resulting in amputation of the affected leg. Limb amputation has a major impact on the individual, not only in distorting body image, but also with regard to loss of productivity, increasing dependency, and costs of treating foot ulcers if patients require inpatient care. After an amputation, prognosis is poor and quality of life is further deteriorated. In a 5-year follow-up study on patients who underwent amputation due to diabetic foot ulcers, 49% had undergone a second amputation, 68% had died and only 19% of the patients with a lower leg amputation were able to walk 1 km. It was also observed in a study that 39-68% of patients who have an amputation will die within 5 years after surgery. Hence, treating diabetic foot ulcer and avoiding amputation holds a significant role and has become a challenging task to accomplish in the management of diabetic foot ulcer. Ayurveda is an authentic medical science which has a holistic approach to maintain the health of healthy individuals and also to cure the diseased ones. It talks about diseases affecting the body and the mind which can either be caused as a result of Internal vitiation of doá¹£a or caused as a result of an external injury. Vrana is one such entity which can be resulted both due to vitiation of doá¹£a and also due to an external injury. Acharya Sushruta has elaborately explained about dushta vrana in Sushruta Samhita and has mentioned 60 specific treatment modalities for the management of a dushta vrana. While explaining the lakshanas of dushta vrana he mentions features like puti puya, puti maá¹ƒsa, puti sira, puti snayu etc which indicates a non-healing ulcer and which can be seen even in case of a diabetic ulcer caused due to uncontrolled diabetes or due to an injury in a patient having increased blood glucose levels. Also, while explaining the prognosis of dushta vrana he clears that vrana in a madhumehi i.e Madhumehajanya vrana as considered in the present study, resulted due to an external injury or due to prameha pidaka, is difficult to treat and takes longer time to heal. In this regard Madhumehajanya vrana can also be considered under dushta vrana and same line of treatment of dushta vrana can be employed even in treating madhumehajanya dushta vrana. Ayurveda has elaborate explanation on the management of Duá¹£á¹a vraá¹‡a which involves Shashti upakrama, whose principles when used properly can result in healing of even stubborn non healing ulcers like diabetic foot ulcers. Selection of the specific treatment among these 60 upakrama depends on the condition of the patient and also on the yukti of the Vaidya. In this study, Deepana-Pacana, Sadhyo Virecana, Parisheka and Taila Pichu prayoga are selected to formulate a comprehensive treatment protocol which can be followed to manage madhumehajanya dushta vrana with special reference to diabetic foot ulcer. The comprehensive treatment protocol planned for a period of 30 days includes three days of deepana-pacana, Sadhyo Virecana on the fourth day, followed by Parisheka and taila Pichu prayoga for 26 days or till the complete healing of the wound, whichever is earlier. Deepana-Pacana stimulates the agni and removes the ama which is the primary cause of all diseases. Madhumehajanya dushta vrana can be considered as an upadarava of madhumeha, having predominance of pitta and kapha, so Sadhyo virecana planned in this condition helps in koshta shuddhi by eliminating the doá¹£a. Later, Parisheka done before the taila pichu prayoga helps in removal of slough and sodhana of vrana. Viparitamalla taila is selected here as an interventional drug for taila pichu prayoga because of its peculiar indication that it can be used even in those patients who do not follow specific diet and regimens that are required for proper healing of the wound. Hence, in the present study a black box design comprehensive protocol will be formulated and will be evaluated in the management of dushta vrana in madhumehi or madhumehajanya dushta vrana vis-Ã -vis diabetic foot ulcer.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Subjects who are Madhumehi (Diabetic) with the clinical features of Duá¹£á¹a vraá¹‡a (Diabetic foot ulcer) with Type I or Type II Diabetes Mellitus will be included.
Subjects will be selected irrespective of age and gender.
Subjects with or without Hypertension will also be included.

Exclusion Criteria

Subjects with Madhumehajanya Duá¹£á¹a vraá¹‡a with associated features of gangrene will be excluded.
Subjects with Madhumehajanya Duá¹£á¹a vraá¹‡a involving bone will be excluded.
Subjects with other systemic diseases like HIV, HBsAg, any Malignancy, DVT, Tuberculosis etc will be excluded.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of the proposed comprehensive treatment protocol in the management of Madhumehajanya Dushta Vrana	Outcomes will be assessed: \| 1. Before starting the intervention \| 2. After 3rd day (After Deepana and Pachana) \| 3. After 4th day (After Sadhyo Virechana) \| 4. Here onwards Every 5 days once for 1 month(study period) or till complete healing of the wound (whichever is earlier) \| Follow up is done once a week for 1 month after completion of the treatment duration or complete healing of the wound (whichever is earlier)

Secondary Outcome Measures

Name	Time	Method
To formulate a comprehensive treatment protocol for the management of	Madhumehajanya duá¹£á¹a vraá¹‡a vis-Ã -vis Diabetic foot ulcer.

Trial Locations

Locations (1): Ayurveda Mahavidyalaya, Hubballi
🇮🇳
Dharwad, KARNATAKA, India
Ayurveda Mahavidyalaya, Hubballi
🇮🇳Dharwad, KARNATAKA, India
DrNarayan KR
Principal investigator
8951218198
danu.nani@gmail.com