The effects of topical Benzalkonium chloride (BAC) wound gel on chronic infections in Diabetes Related Foot Ulcers (DRFUs): An in vivo proof of concept study

Not Applicable

• Conditions: diabetes; diabetic foot ulcer; chronic wound; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12623000154606
• Lead Sponsor: South Western Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-16
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Diagnosis of either 1 or type 2 diabetes mellitus
2. Aged over 18 years
3. Diabetes-related foot ulcer occurring below the malleolus stratified by; DRFU with a suspicion of chronic infection with foot ulcers greater than or equal to 5 week’s duration with no observed changes in wound metrics over a lead-in period of four consecutive weeks prior to enrolment.

Exclusion Criteria

1. Malignant ulcers
2. Ulcers associated with chemotherapy
3. Venous ulceration
4. Thermal injuries (burns)
5. Current uncontrolled anticoagulation therapy such as warfarin, clopidogrel and International Normalised Ratio (INR) >2.0
6. New acute diabetes related foot infection requiring new antibiotic regimen
7. Currently being treated for osteomyelitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified