Health Condition 1: L089- Local infection of the skin and subcutaneous tissue, unspecified
Conditions
Sponsors
Dr Vikas Gautam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult men and women aged 18 years or older 2. A diagnosis of diabetic ulcer or limb ulcer (arterial or venous ulcer) or decubitus (pressure) ulcer; and 3. Wound size
Exclusion criteria
Exclusion criteria: 1. Infection to be cured with antibiotics 2. Deep ulcer reaching bone tissue 3. Severe edema around skin ulcer, 4. Patients with severe heart failure, severe liver, kidney, and blood dysfunction, 5. Poor general condition due to severe systemic infection, 6. Poor control of hyperglycemia (HbA1c â?§9.0%) 7. Pregnant women, and men or women who disagree to avoid pregnancy during clinical trial period 8. Surgical procedure for skin ulcer from 2 weeks before SEPIL or placebo treatment, 9. Participation in other clinical trial from 12 weeks before entry, 10. Judgment as an inappropriate patient by principle investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be the rate of wound size reduction at 4 weeks after the first treatment compared with pre-treatment wound size.Timepoint: The safety of SEPIL topical treatment will be evaluated during the treatment period (28 days) every 7 days and post-treatment (30 days) according to the Common Terminology Criteria for Adverse Events (version 5.0). | — |
Secondary
| Measure | Time frame |
|---|---|
| Additionally, the following secondary endpoints will be measured at 4 weeks after the first treatment and compared with pre-treatment status: time to wound closure; 50% wound size reduction ratio; quantification of Gram-negatives- Pseudomonas aeruginosa, Acinetobacter, Klebsiella, Escherichia coli and others; Gram-positives -Staphylococcus aureus (includingmethicillin resistant S. aureus, MRSA), Streptococcus pyogenes; and overall evaluated ulcer improvement.Timepoint: Secondary endpoints will be measured at 4 weeks after the first treatment and compared with pre-treatment status | — |
Countries
India
Contacts
Public ContactDr Neeraj Arora
Civil Hospital
Outcome results
None listed