Testing of a herbal antiseptic for wound infections

Not Applicable

• Conditions: Health Condition 1: L089- Local infection of the skin and subcutaneous tissue, unspecified

• Registration Number: CTRI/2020/11/029257
• Lead Sponsor: Dr Vikas Gautam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 <10 cm in diameter (preferably).

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 (including methicillin 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