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. 2021 Aug 3;22(1):517.
doi: 10.1186/s13063-021-05472-6.

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

Meryl Cinzía Tila Tamara Gramberg  1 , Rimke Sabine Lagrand  2 , Louise Willy Elizabeth Sabelis  2 , Martin den Heijer  3 , Vincent de Groot  2 , Max Nieuwdorp  4 , Willemijn Kortmann  5 , Elske Sieswerda  6 , Edgar Josephus Gerardus Peters  3
Affiliations

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

Meryl Cinzía Tila Tamara Gramberg et al. Trials. .

Abstract

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.

Keywords: Antibacterial therapy; Bone biopsy; Osteomyelitis in diabetic foot.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow chart of study design
Fig. 2
Fig. 2
Flow chart of study courses. *We will perform additional analysis allowing for antibacterial therapy longer than 6 weeks and treatment based on unblinded cultures
See this image and copyright information in PMC

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