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The Potential use of Larval Therapy/Biogun and Silver to Reduce Colonisation of MRSA in Diabetic Foot Ulcers. - Use of Larvae/Biogun and Silver in Diabetic Foot Ulcers

Conditions
Methicillin Resistant Staphylococcus Aureus (MRSA)
Registration Number
EUCTR2007-002571-14-GB
Lead Sponsor
The University of Manchester
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Type 1 or 2 diabetes
Age 18-75
Active foot ulceration
Prsence of significant neuropathy: Vibration Perception Threshold > 25 volts and Neuropathy Disability Score >3/10
MRSA isolated from the active ulcer site on two consecutive specimens
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Presence of peripheral vascular disease requiring urgent surgical management
Wounds in which the MRSA is the primary infecying organism rather than colonisation
Known history of poor medical compliance
Wounds requiring systemic antibiotic treatment
Anti-coagulant therapy
Patients who do not consent
Pregnant or breastfeeding women

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: The eradication of MRSA in diabetic foot ulcers;Secondary Objective: Time to eradication<br>Mechanism of action of larvae in eradicating MRSA;Primary end point(s): Eradication of MRSA from colonized diabetic foot ulcers
Secondary Outcome Measures
NameTimeMethod
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