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Assessment of the safety of a 'medieval antibiotic' used to treat infected diabetic ulcers on the skin of healthy non-diabetic volunteers

Assessment of safety of a 'medieval antibiotic' to treat infected diabetic ulcers: a Phase 1 trial in healthy volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10773579
Enrollment
100
Registered
2021-01-08
Start date
2021-06-07
Completion date
Unknown
Last updated
2022-12-05

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

Conditions

Prevention/treatment of infection in diabetic foot and leg ulcers Infections and Infestations Ulcer infection in diabetes mellitus with peripheral circulatory complications

Interventions

Sticking plaster infused with one drop of the liquid ancientbiotic preparation will be applied to the skin of the upper arm and worn for 48 h. Ancientbiotic preparation is equal amounts by volume of g

Sponsors

University of Warwick
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime frame
There are no secondary outcome measures

Countries

England, United Kingdom

Contacts

Public ContactFreya Harrison
F.Harrison@warwick.ac.uk+442476524744

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026