Assessment of the safety of a 'medieval antibiotic' used to treat infected diabetic ulcers on the skin of healthy non-diabetic volunteers
Not Applicable
Completed
- Conditions
- Prevention/treatment of infection in diabetic foot and leg ulcersInfections and InfestationsUlcer infection in diabetes mellitus with peripheral circulatory complications
- Registration Number
- ISRCTN10773579
- Lead Sponsor
- niversity of Warwick
- Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36385621/ (added 18/11/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 109
Inclusion Criteria
1. Aged 18 to 79 years
2. Willing to provide signed consent to participate in the study
3. Fluent in spoken English to allow engagement with study
4. Willing to be contacted by telephone, email, or video-based platform at follow-up
5. Willing for the research team to hold a photographic image if any skin irritation occurs
Exclusion Criteria
1. Pregnancy
2. Diabetes
3. Any known allergies or recent infection (within 3 months), including COVID-19 infection
4. Any skin condition, including eczema or psoriasis, or broken skin on the upper arms
5. Any diagnosis of asthma
6. Unable to be contacted by email, phone, or video platform within 48 h of intervention delivery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Adverse effects (AE) over 48 h measured using:<br> 1.1. Participant questionnaire, where participants are asked to record the presence/absence of wound symptoms (erythema, spreading erythema, itch, discomfort, heat, pain, other adverse reactions) at 48 h<br> 1.2. Digital photographs of the affected area where any suspected AE has occurred (to record the type, number, and spread/distribution of AEs) at 48 h<br> 1.3. A skin sample (in 5 participants) from participants with no AEs at 48 h<br>
- Secondary Outcome Measures
Name Time Method There are no secondary outcome measures