TY - JOUR
T1 - Using a BonE BiOPsy (BeBoP) to determine the causative agent in persons with diabetes and foot osteomyelitis
T2 - study protocol for a multicentre, randomised controlled trial
AU - Tila Tamara Gramberg, Meryl Cinzia
AU - Lagrand, Rimke Sabine
AU - Elizabeth Sabelis, Louise Willy
AU - den Heijer, Martin
AU - de Groot, Vincent
AU - Nieuwdorp, Max
AU - Kortmann, Willemijn
AU - Sieswerda, Elske
AU - Gerardus Peters, Edgar Josephus
N1 - Funding Information:
This work was supported by the Dutch Diabetes Research Foundation grant number 2017.82.014.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - 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.
AB - 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.
KW - Biopsy
KW - Diabetes Mellitus
KW - Diabetic Foot/diagnosis
KW - Humans
KW - Multicenter Studies as Topic
KW - Netherlands
KW - Osteomyelitis/diagnosis
KW - Quality of Life
KW - Randomized Controlled Trials as Topic
KW - Bone biopsy
KW - Osteomyelitis in diabetic foot
KW - Antibacterial therapy
UR - http://www.scopus.com/inward/record.url?scp=85111990639&partnerID=8YFLogxK
U2 - 10.1186/s13063-021-05472-6
DO - 10.1186/s13063-021-05472-6
M3 - Article
C2 - 34344428
SN - 1745-6215
VL - 22
SP - 1
EP - 10
JO - Trials
JF - Trials
IS - 1
M1 - 517
ER -