Post Market Study to Evaluate the Safety & Efficacy of product UrgoClean Ag in the Management of Diabetic Foot Ulcers

Phase 4

Completed

• Conditions: Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases

• Registration Number: CTRI/2020/12/029670
• Lead Sponsor: Eucare Pharmaceuticals Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-12-18
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

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

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)

GradeABIAnkle systolic pressureTP, TcPO 2

0>=0.80 >100 mm Hg>=60 mm Hg

10.6-0.7970-100 mm Hg40-59 mm Hg

20.4-0.5950-70 mm Hg30-39 mm Hg

3<=0.39 <50 mm Hg <30 mm Hg

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

Study & Design

• Study Type: PMS
• Study Design: Not specified