Clinical study to evaluate the safety of SIS WOUNDCARE â?? DEVICE for chronic wound healing.
- Conditions
- Health Condition 1: L08- Other local infections of skin andsubcutaneous tissue
- Registration Number
- CTRI/2021/09/036203
- Lead Sponsor
- SIS MANUFACTURING LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients with age above 18.
2.Subject has Venous Ulcer or Diabetic Ulcer with a surface area < 100 sq. cm and < 10 cm in widest diameter on lower extremity, but larger than 1 sq. cm
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 Improvement in wound status by BATES-JENSEN WOUND ASSESSMENT TOOL <br/ ><br>2 Subject assessment by QOL questionnaire <br/ ><br>Timepoint: From baseline to EOT
- Secondary Outcome Measures
Name Time Method To evaluate safety by monitoring the adverse events.Timepoint: From baseline to EOT