A clinical trial to study the effects of topical sucralfate and sucralfate with mupirocin in patients with chronic skin ulcers
- Conditions
- Health Condition 1: null- Chronic skin ulcers
- Registration Number
- CTRI/2015/12/006443
- Lead Sponsor
- Strassenburg Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 90
Patients of either sex of age > 18 years
Patients having grade 1 and grade 2 ulcer according to Wagner grading system.
Ulcer of duration > 4 weeks.
Wagner grading system
AGrade 1Superficial ulcer
BGrade 2Ulcer extension
1. Involves ligament, tendon, joint capsule or fascia
2. No abscess or osteomyelitis
CGrade 3Deep ulcer with abscess or osteomyelitis
DGrade 4Gangrene
EGrade 5Extensive gangrene
Female patients who are pregnant or breast-feeding.
Patients having ulcer grade >2 according to Wagner grading system
Ulcer of duration > 6 months.Patients diagnosed to have decubitus ulcer.
Patients diagnosed to have ulceration due to malignancy.
Patients who have used formulations containing mupirocin or sucralfate for their ulcer within the last 4 weeks.
Patients with history of hypersensitivity to formulations containing mupirocin or sucralfate.
Patients suffering from debilitating chronic diseases including frankly uncontrolled diabetes and advanced malignancy.
Patients suffering from frankly immunocompromising disorders such as HIV/AIDS.
Patients on systemic antimicrobials, corticosteroids or any other medication known to influence wound healing currently or within last 4 weeks.
Patients suffering from alcoholism, substance abuse or psychiatric disorders that are liable to make them unreliable trial subjects.
Patients without adequate caregiver support at home who can supervise application of medication.
Any other condition which, in the opinion of the investigators, is likely to substantially increase the risk of non-adherence or the possibility of confounding of results.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in ulcer area from baseline. <br/ ><br>Number of subjects achieving at least or more than 50% reduction in ulcer area . <br/ ><br>Timepoint: 6 weeks
- Secondary Outcome Measures
Name Time Method lcer qualitative parameters on a 3 point scale â?? Wound infection score.Timepoint: day0,3 weeks,6 weeks