Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
None listed
Sponsors
Indian Council of Medical Research National Institutional Traditional Medicine Belagavi
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients of either sex in the age group of 20 to 60 years 2 Patient having DFU classified as per the university of Texas grade 1 and 2 with stage A and B size of 15 to 40 cm2 for a duration of more than one month 3 Patients who voluntarily provide written informed consent and were ready to follow procedures as per the study protocol 4 For DFU patients having either Type II DM with HbA1C of less than 8 with non-healing single or multiple ulcers neuropathic or mild neuro ischemic ulcer
Exclusion criteria
Exclusion criteria: 1 Patients with ischemic ulcers Diagnosed Clinically or with Doppler 2 Known cases of severe chronic hepatic or renal disease 3 Known cases of any active malignancy 4 Having history of significant cardiovascular event less than12 weeks prior to recruitment chronic alcoholics or alcohol abuse 5 Patients ECG demonstrating any signs of uncontrolled arrhythmia or acute ischemia 6 Patient with history of tuberculosis contagious infectious disease such as Hepatitis B or C or HIV 7 Patients using any other investigational drug within 1 month prior to recruitment 8 Known hypersensitivity to any of the ingredients used in study drug 9 Pregnant and Lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of Ulcer mean surface areas by graph paper Assessment of ulcer healing process by Bates Jensen ulcer assessment tool Evaluation of ulcer healing process by clinical examination for evaluation of depth of ulcer undermining ulcer edges necrotic tissue type and amount type and amount of exudates appearance of skin colour around the ulcer peripheral tissue edema peripheral tissue induration granulation of ulcer epithelialization of ulcer will be done on every visit on graded scale on Bates Jensen ulcer assessment tool and will be compared with baseline Timepoint: Baseline day15 day30 day45 day60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of ulcer healing process by digital photographs Timepoint: Baseline day15 day30 day45 day60 | — |
Countries
India
Contacts
Public ContactDr Pradeep Shahjirao Shindhe
KAHER Shri B M K Ayurveda Mahavidyalaya Belagavi
Outcome results
None listed