Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases
Conditions
Interventions
Intervention1: UrgoClean Ag is a sterile, non-woven pad made of soft-adherent TLC-Ag Healing Matrix and poly-absorbent fibres, an antimicrobial dressing with anti-biofilm efficacy providing a complete
Sponsors
Eucare Pharmaceuticals Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male/ female patient Ë?18 years and Ë? 100 years 2.Patient who can and willing to provide written Informed Consent 3.Patient who has Diabetic foot ulcers which the investigator decides to employ UrgoClean Ag 4.Patient who understands and is willing to participate in the clinical study and can comply with regular treatment visits and the follow-up regimen
Exclusion criteria
Exclusion criteria: 1. Patient with known allergy/hypersensitivity to silver or any of the dressing component 2. Patient having a medical or social condition that would, in the opinion of the investigator, place the patient at an unacceptable risk or render the patient unable to meet the requirements of the protocol 3. Patient with Severe lower limb ischemia (WIFI Classification 2 and 3), severe hepatic insufficiency, on renal dialysis, systemic steroid treatment, chemotherapy, immunodeficiency WIFI Classification (Society for Vascular Surgery) Grade ABI Ankle systolic pressure TP, TcPO 2 0 >=0.80 >100 mm Hg >=60 mm Hg 1 0.6-0.79 70-100 mm Hg 40-59 mm Hg 2 0.4-0.59 50-70 mm Hg 30-39 mm Hg 3 4. Patient has participated in another clinical study involving another investigational agent within 4 weeks of the start of this trial, or is planning participation in another clinical trial during the current study duration 5. Patients treated with wound dressings that include growth factors, bioengineered tissues, or skin substitutes other than the study material, within 30 days of the screening visit and throughout the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety of Sterile, non-woven padTimepoint: Visit 1 to Visit 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate change in wound surface area of diabetic foot ulcers To assess overall healing progression To assess the change in wound characteristics To assess overall performance of the dressingTimepoint: Change in wound surface area from baseline to End of study visit (Visit 4, Day 28) [ Time Frame: 4 weeks ] Assessment of overall wound healing progression since baseline visit (Visit 1, Day 0), at Intermediate visits (Visit 2, Day 14), (Visit 3, Day 21) and End of study visit (Visit 4, Day 28). | — |
Countries
India
Contacts
Public ContactMr Vairamuthu Ammaiyappan
iDD Research Solutions Private Limited
Outcome results
None listed