Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: Multimodal Imaging device: The device shines multiple light sources from UV, Visible , IR, NIR and capture multispectral images for under 1 minute and the AI algorithm gives a comprehen
Sponsors
ADIUVO DIAGNOSTICS PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: Ulcer both arterial and venous Diabetic Foot Ulcer
Exclusion criteria
Exclusion criteria: 1. Subjects with significant inhalation injuries necessitating intubation and mechanical ventilation on a continuous basis 2. Known history of HIV infection, or active Hepatitis B or active Hepatitis C infection 3. Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compares standard method of visual inspection and clinical evaluation of wounds with Microbial culture sensitivity testing, Transcutaneous oxygen pressure (TcPO2) against a novel non-invasive Multimodal imaging device that detects/measures the following 1. Bacteria Detection 2. Gram Type Bacterial Classification 3. Wound Depth, Length, Breadth 4. Tissue Oxygen SaturationTimepoint: 1 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Statiscal analysis of standard methods vs the multimodal imaging device.Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr C Sheela Sasikumar
S.S.Healthcare
Outcome results
None listed