Health Condition 1: L08- Other local infections of skin andsubcutaneous tissue
Conditions
Interventions
Intervention1: SIS WOUNDCARE â?? DEVICE: The SIS wound care device is intended for extended, continuous application, typically up to 10 hours treatment session duration The device application will be
Sponsors
SIS MANUFACTURING LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with age above 18. 2.Subject has Venous Ulcer or Diabetic Ulcer with a surface area 3.Subject has wound present for more than 30 days despite appropriate wound care 4.Subject has adequate blood perfusion 5.Subject is able to understand and provide written consent.
Exclusion criteria
Exclusion criteria: 1.Subject has Active Infection 2.Subject has Untreated Osteomyelitis 3.Subject has Allergy to Wound Care Products used in the study 4.Subject has Malignancy, Burn, Collagen Vascular Disease, Sickle Cell, Vasculopathy, or Pyoderma Gangrenosum Origin of Wound 5.Subject has Active Charcot Arthropathy of the Foot 6.Subject has study wound location on toes or plantar surface of foot 7.Subject has uncontrolled hyperglycaemia 8.Subject has end stage renal disease requiring dialysis 9.Subject is undergoing active chemotherapy treatment that inhibits wound healing or has identified cancer 10.Subject has had previous treatment with NPWT device, growth factors, hyperbaric oxygen, or bioengineered tissue product within 30 days of enrolment 11.Subject has a >30% wound surface area reduction in size at 1 week after screening visit 12.Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study 13.Subject is unwilling or unable to comply with protocol requirements 14.Subject is pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Improvement in wound status by BATES-JENSEN WOUND ASSESSMENT TOOL 2 Subject assessment by QOL questionnaire Timepoint: From baseline to EOT | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate safety by monitoring the adverse events.Timepoint: From baseline to EOT | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed