DOMINO-DFU: A study looking at optimising diagnosis of bone infection in people with a diabetic foot ulcer

Not Applicable

• Conditions: Osteomyelitis in diabetes with foot ulcer; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN93847463
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-06
• Last Update Posted: 26 August 2024
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 4500

Inclusion Criteria

Full clinical cohort:
1. Aged 18 years or over
2. Diagnosed with diabetes mellitus (according to WHO criteria)
3. New active diabetic foot ulcer, as defined by a wound below the malleoli in a person with diabetes
4. Consent to participate (written/witnessed verbal informed consent)

High-risk clinical cohorts:
1. Exhibit one of the following high-risk features for DFO:
1.1. Clinical infection (IDSA criteria) + positive Probe to Bone (PTB); or
1.2. Ulcer with area =2 cm²; or
1.3. Ulcer PTB or
1.4. Ulcer depth =3 mm; or
1.5. Dactylitis; or
1.6. Hard-to-heal” as defined by failure to heal by >50% in the previous 4 weeks

High-risk phase 2 diagnostic concordance study cohort:
1. Provide second-level consent for both ‘through-the-ulcer’ and ‘remote’ bone biopsies

Exclusion Criteria

No exclusion criteria for full clinical cohort or phase 1 and 3 high-risk cohorts (as advised by PPI members).

High-risk phase 2 diagnostic concordance study cohort:
1. Unable to undergo both ‘through-the-ulcer’ and ‘remote’ bone biopsies
2. Would not be ethically appropriate to approach the patient e.g. on end of life care

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Clinical diagnosis of diabetic foot osteomyelitis (DFO) over 52 weeks from baseline collected from clinical notes (full cohort)<br>2. Standard care for DFO over 12 months collected from clinical notes (Phase 1)<br>3. Antibiotic use over 12 months collected from clinical notes (Phase 1)<br>4. Presence and subtype of histological evidence of DFO from bone sample taken at baseline (Phase 2)<br>5. Presence and number of pathogens per bone sample collected at baseline (Phase 2)<br>6. Clinical diagnosis of DFO over 52 weeks from baseline collected from clinical notes (Phase 3)