Bedside Bone Biopsy in Diabetic Foot Osteomyelitis

Summary

During their lifetime, 15 to 25% of patients with diabetes mellitus will develop a Diabetic Foot Ulcer (DFU) related to neuropathy and/or peripheral arterial disease. DFU is the leading cause of non-traumatic lower-extremity amputation worldwide. Diabetic foot osteomyelitis (DFO), which complicates up to 60% of DFU, is a major trigger of amputation in over 80% of persons with diabetes resulting in subsequent loss of quality of life. It has been shown that medical treatment of DFO may prevent amputations with early diagnosis of osteomyelitis and appropriate use of antibiotics. Empirical antimicrobial treatment is not recommended for DFO as for other chronic infections. Surgically or radiologically acquired bone sample for culture is the reference standard recommended by the International Working Group of Diabetic Foot (IWGDF) to diagnose DFO and to determine the causative bacteria and their susceptibility. However, defining appropriate antimicrobial therapy directed to the causative bacteria in DFO is challenging since it requires bone biopsy (BB) procedures which are underused in clinical practice for various reasons: lack of availability, cost, and delay. Some clinicians also find bone biopsy cumbersome or too invasive.

To overcome these barriers, we have set up for a few years a bedside blind BB procedure performed by diabetologists at the bedside in the clinical ward. Since then, this method has been used in more than 200 patients with DFO in the diabetology departments of Lariboisiere Hospital and Bichat Hospital (Paris). We have recently published our observational data of 79 patients showing that bedside BB is a simple, safe and efficient procedure for the diagnosis of DFO with a similar rate of complete healing at 12 months compared to conventional surgical or radiological bone biopsies. In order to extend and confirm these preliminary and observational results, the aim of this study is to compare the efficiency and safety of bedside BB versus conventional bone biopsy in a randomized controlled trial (RCT) of patients with DFO. Our hypothesis is that bedside BB is non-inferior to conventional bone biopsy in DFO and can be used as a simpler alternative procedure to document DFO

Conditions

• Subjects With Diabetes and DFU With a Suspicion of DFO

Interventions

PROCEDURE

Bedside blind bone biopsy procedure

It was performed in the patient's room under aseptic conditions. Pain relievers were given orally within the hour preceding the procedure. Superficial anesthesia was performed firstly subcutaneously and then on the periosteum, Inhaled anesthesia was started concomitantly. Following a short incision with a scalpel, the trocar inside a cannula was inserted through healthy skin at a minimum distance of 2 cm from the ulcer edge, close to the bone, preferentially on dorsal foot side. When the trocar was firmly inserted into the bone, it was pulled out from the cannula. Biopsy needle was then slipped into the cannula and twisted into the bone clockwise. Biopsy needle was then pulled out and the bone was pushed out with the ejector pin into a sterile surgical drape and divided in two parts.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Louis Potier, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-14

Primary Completion

2027-03-31

Completion

2027-10-31

Countries

• France

Study Locations