Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: for neuropathy, 1)Individuals with type 2 diabetes mellitus clinically diagnosed with peripheral neuropathy 2)Individuals with VPT >= 20 3)Age group between 18 to 70 years 4)Both genders For ulcer, 1)Wagner classification grade 0,1 or 2.
Exclusion criteria
Exclusion criteria: 1)Patients with pacemaker 2)Open, inflamed or infected skin surface of the foot 3)Deep vein thrombosis 4)Other macrovascular complications 5)Musculoskeletal, neurological impairment, malignancy and pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neuropathy: 1)Serum levels of pain markers Nerve growth factor (NGF) Neurone specific enolase (NSE) Calcitonin gene-related peptide (CGRP) Ulcer: 1)Area of ulcer Timepoint: neuropathy, At baseline andreassessed at the end of the 10th day (only clinical) and 30th day (clinical and biochemical) ulcer, At baseline and Interim assessment will be at 8th week and reassessment of all outcome measures will be at 12th week | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)VPT 2)Mischigan neuropathy screening instrument (MNSI) 3)Numeric Pain Rating Scale 4)WHO-QOL Bref Timepoint: At baseline, 10th day and on 30th day | — |
Countries
India
Contacts
Manipal college of health professions, MAHE, Manipal