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A clinical trial to study the effects of topical sucralfate and sucralfate with mupirocin in patients with chronic skin ulcers

A randomized controlled trial of topical Mupirocin versus Mupirocin with Sucralfate combination in chronic skin ulcers.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/12/006443
Enrollment
90
Registered
2015-12-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Chronic skin ulcers

Interventions

Intervention1: SUCRALFATE WITH MUPIROCIN: Topical mupirocin 2% with Sucralfate 7% to be applied 3 times daily for 6 weeks or until ulcer healing whichever is earlier Control Intervention1: MUPIROCIN:

Sponsors

Strassenburg Pharmaceuticals Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 A Grade 1 Superficial ulcer B Grade 2 Ulcer extension 1. Involves ligament, tendon, joint capsule or fascia 2. No abscess or osteomyelitis C Grade 3 Deep ulcer with abscess or osteomyelitis D Grade 4 Gangrene E Grade 5 Extensive gangrene

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Reduction in ulcer area from baseline. Number of subjects achieving at least or more than 50% reduction in ulcer area . Timepoint: 6 weeks

Secondary

MeasureTime frame
Ulcer qualitative parameters on a 3 point scale â?? Wound infection score.Timepoint: day0,3 weeks,6 weeks

Countries

India

Contacts

Public ContactDr Subhrangsu Chatterjee

Institute of Postgraduate Medical Education & Research, Kolkata â?? 700020

blowfans@yahoo.co.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 2, 2026