Clinical Research Directory

Inclusion Criteria: * Patients of either gender between 40 to 75 years with a diagnosis of chronic diabetic neuropathic pain that is restricted to the foot area only. Patients experiencing everyday pain in their lower extremities (one or both legs). Patients with a pain score of 4 or higher on the Visual Analogue Scale (VAS) from 0 to 10 at screening and enrollment (after a seven-day washout period). Patients scoring 12 or higher on the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale. Patients with grade 0 or grade I diabetic foot status without active ulceration or infection, ensuring safe application of ultrasound-based therapies. Presence of protective sensation loss, temperature discrimination impairment, or early microvascular changes commonly associated with diabetic foot risk. Patients having HbA1c concentration levels below 12.2 % on screening. Exclusion Criteria: * Patients who have any complications of diabetes, including nephropathy, retinopathy or need for dialysis. Patients who have active diabetic foot ulcers, infection, gangrene, Charcot foot, deep callus fissure, or open wounds in which the use of ultrasound is contraindicated. Patients with a primary complaint of severe foot deformities that can potentially affect nerve symptoms. Orthopaedic or neurological foot patients who do not have diabetic neuropathy can exhibit symptoms of peripheral neuropathy. Patients who have Vitamin B12 deficiency (\<180 ng/L), uncontrolled hypothyroidism, or other metabolic diseases which in themselves result in neuropathy. Patients who have severe oedema, skin dermatological conditions on the site of application (eczema, dermatitis, skin hypersensitivity), and have intolerance of ultrasound gel or topical formulations. Patients with a history of alcohol abuse, pregnant and lactating women.