Diabetic foot ulcer infection Infections and Infestations
Conditions
Interventions
The trial is a multi-centre, Phase III, open, prospective, parallel group, randomised controlled trial (RCT) comparing two sample collection techniques (swab and tissue sampling) in clinically infecte
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. 18 years of age or older at the time of signing the consent form 2. Diagnosis of diabetes mellitus (according to WHO criteria) 3. Presence of a DFU that is suspected as a mild or moderate soft tissue infection (as per IDSA guidelines) 4. Able and willing to provide informed consent for participation in the study 5. Consent for foot photography
Exclusion criteria
Exclusion criteria: 1. Index ulcer present for > 2 years 2. Presence of suspected osteomyelitis of the index limb 3. Previous participation in the trial 4. Not expected to comply with the sampling strategies (i.e. has a preference) 5. Not expected to comply with the follow-up schedule 6. In the opinion of the local investigator the participant’s foot infection is too severe to include them in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Healing of Index Ulcer: Time from randomisation to healing of index ulcer (up to maximum follow-up of 104 weeks). Healing defined as complete epithelialisation, confirmed by a blinded assessor within 3 days after first report of healing; Timepoint(s): End of follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Baseline sampling compliance: Binary (Compliant / Not compliant, according to whether sampling at baseline was as randomised), Timepoints: Randomisation 2. Full sampling compliance: Binary (Compliant / Not compliant, according to whether sampling at baseline and all subsequent sampling was as randomised) Timepoints: from randomisation to 52 weeks (to 104 weeks for patients randomised in the first year) or until healing/amputation/withdrawal/death, if observed first 3. Healing status: Binary (Healed / Not healed, according to primary outcome measure definition) at the timepoint. Timepoints: 12 weeks, 26 weeks, 39 weeks, 52 weeks. (and 104 weeks for those randomised in the first year) 4. Antibiotic prescribing over 52/104 weeks: number of days during follow-up where at least one antibiotic agent was prescribed for the foot of the index ulcer. Timepoint: From randomisation to end of follow-up: either date of death/withdrawal/loss to follow-up, or 52 weeks (for later-randomised participants) or 104 weeks (for participants randomised in the first year) 5. Ulcer area (cm-squared) at 4 weeks post randomisation 6. Quality of life, measured using the 6 subscales of the DFS-SF questionnaire derived from the 29 questions of the full questionnaire. Timepoints: 4 weeks, 12 weeks, 26 weeks, 39 weeks, 52 weeks, 104 weeks 7. Quality of life, measured using the Utility score obtained from the 5 3-level questions of the EQ5D-3L questionnaire tool. Timepoints: 4 weeks, 12 weeks, 26 weeks, 39 weeks, 52 weeks, 104 weeks. 8. Adverse events: counts of number of adverse events relating to diabetic foot ulcer, the sampling technique and antibiotic use. Timepoints: From randomisation to 52 weeks (104 weeks for those randomised in first year) 9. Number of days in hospital: count of number of days admitted related to diabetic foot ulcer over the time at risk (i.e. up to death/withdrawal/loss to follow-up or maximum of 52/104 weeks). Timepoints: From randomisation to either death/withdrawal | — |
Countries
England, United Kingdom
Contacts
Public ContactRachael Gilberts
Outcome results
None listed