Prevention/treatment of infection in diabetic foot and leg ulcers Infections and Infestations Ulcer infection in diabetes mellitus with peripheral circulatory complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Adverse effects (AE) over 48 h measured using: 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 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 1.3. A skin sample (in 5 participants) from participants with no AEs at 48 h | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom