Prescription event monitoring study of Emrok injection and tabin the patient of diabetes foot ulcer.
Phase 4
- Conditions
- Health Condition 1: E088- Diabetes mellitus due to underlying condition with unspecified complications
- Registration Number
- CTRI/2024/04/065615
- Lead Sponsor
- Wockhardt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Subject any gender age 18 years or above.
2. subject must be willing to participate in the study and must provide written inform consent
Exclusion Criteria
subjects with history of hypersensitivity of drug or same class of drug.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Evaluate safety profile of EMROK in patients with DFI <br/ ><br>2. Incidence of adverse events 3. Overall Global Assessment for Safety on 5 point Likert ScaleTimepoint: At day 4 and day 28 or EOT
- Secondary Outcome Measures
Name Time Method 1. Clinical Success Rate at EOT <br/ ><br>2. Clinical Responder Rate / Clinical improvement rate at EOT <br/ ><br>3.Clinical Responder Rate / Clinical improvement rate at Early assessment (Day <br/ ><br>4±2) <br/ ><br>4. Microbiological Success Rate at EOT <br/ ><br>5. Overall Global Assessment for EfficacyTimepoint: At day 4 and day 28 or EOT