Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: It is a single arm clinical trial: warm oxygen therapy will be delivered to individuals with type 2 diabetes mellitus having foot ulcers
Control Intervention1: NOT APPLICABLE because it
Sponsors
Yostra Labs Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Individuals with type 2 diabetes mellitus and non-healing diabetic foot ulcer for 3 months or more
Exclusion criteria
Exclusion criteria: foot ulcers of other pathology, individuals who are referred for surgical interventions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Biomarkers of wound healing, including -Matrix metalloproteinase 1, 2, 8 and 9, 2. Inflammatory markers of endothelial cells including Tumor necrosis factor α and Interleukin-6 3. Rate of contraction of woundTimepoint: Three time points 1.Baseline 2.After 2 weeks 3.After 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Biomarkers of wound healing, including -Matrix metalloproteinase 1, 2, 8 and 9, 2. Inflammatory markers of endothelial cells including Tumor necrosis factor α and Interleukin-6 3. Rate of contraction of woundTimepoint: Three time points 1.Baseline 2.After 2 weeks 3.After 8 weeks | — |
Countries
India
Contacts
Public ContactMegha Nataraj
Manipal College of Health Professions
Outcome results
None listed