Journal Article

Using a BonE BiOPsy (BeBoP) to determine the causative agent in persons with diabetes and foot osteomyelitis: study protocol for a multicentre, randomised controlled trial

Lagrand, Rimke Sabine, Peters, Edgar Josephus Gerardus, den Heijer, Martin, de Groot, Vincent, Nieuwdorp, Max, Sieswerda, Elske, Gramberg, Meryl Cinzía Tila Tamara, Kortmann, Willemijn, Sabelis, Louise Willy Elizabeth

2021

Overview

Background Diabetic foot osteomyelitis (DFO) poses a major disease burden. It can generally be treated with long-term antibacterial therapy. International guidelines recommend to base antibacterial therapy choices on percutaneous bone biopsy culture, while in practice, therapy is frequently based on (less invasive) ulcer bed cultures. It is currently unknown if treatment outcomes of DFO differ depending on the chosen diagnostic strategy. Methods The BeBoP trial is a multicentre; randomised controlled; physician-, researcher- and subject-blinded; clinical trial comparing two diagnostic strategies in persons with DFO. Culture-directed antibacterial therapy will be based on either percutaneous bone biopsy culture results (intervention group) or ulcer bed biopsy culture results (comparison group). We will enrol 80 subjects with diabetes mellitus (≥ 18 years) and DFO, and we will use block randomisation stratified per centre to randomise them in a 1:1 allocation. The primary outcome is remission of DFO 12 months after enrolment. The secondary outcomes are the time to remission, signs of inflammation or ulceration at the primary location of infection at 6 and 12 months, microbiological and molecular profiles of culture outcomes, surgical interventions including amputation, total antibacterial therapy duration, infection-free survival days, adverse events, quality of life and survival. We will compare the outcomes by intention-to-treat and per-protocol analysis. Discussion We aim to compare clinical remission in persons with DFO treated with antibacterial therapy based on either percutaneous bone biopsy culture results or ulcer bed biopsy culture results. Trial registration Netherlands Trial Register NL 7582 . Registered on 05 March 2019

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Abscesses / Amputation / Antibacterial therapy / Bacteria / Biomedicine / Biopsy / Bone biopsy / Causes of / Cohort analysis / Compartment syndrome / Development and progression / Diabetes / Diabetes Mellitus / Diabetic foot / Diabetic Foot - diagnosis / Diabetic Foot - drug therapy / Diagnosis / Foot diseases / Health Sciences / Humans / Infections / Inflammation / Informed consent / Intervention / Medicine / Medicine & Public Health / Multicenter Studies as Topic / Netherlands / Osteomyelitis / Osteomyelitis - diagnosis / Osteomyelitis - drug therapy / Osteomyelitis in diabetic foot / Pathogens / Quality of Life / Randomized Controlled Trials as Topic / Statistics for Life Sciences / Study Protocol / Ulcers