Antibiotics vs Surgery for Diabetic Foot Osteomyelitis
Antibiotics vs Surgery for Diabetic Foot Osteomyelitis
Objective: No prospective trials have been carried out comparing antibiotic treatment alone with primarily surgical treatment in patients with diabetes and foot osteomyelitis. The aim of the current study was to compare the outcomes of the treatment of diabetic foot osteomyelitis in patients treated exclusively with antibiotics versus patients who underwent conservative surgery, following up the patients for a period of 12 weeks after healing.
Research design and methods: Between 1 January 2010 and 31 December 2012, a prospective randomized comparative trial (clinical trial reg. no. NCT01137903,clinicaltrials.gov) of patients with diabetes who had received a diagnosis of neuropathic foot ulcers complicated by osteomyelitis was carried out at the Diabetic Foot Unit at the Complutense University of Madrid. Patients were randomized into the following two groups: the antibiotics group (AG) and the surgical group (SG). Antibiotics were given for a period of 90 days in the AG. Patients in the SG received conservative surgery with postoperative antibiotic treatment for 10 days.
Results: Eighteen patients (75%) achieved primary healing in the AG, and 19 (86.3%) in the SG (P = 0.33). The median time to healing was 7 weeks (quartile [Q] 1 to Q5, Q3–Q8) in the AG and 6 weeks (Q1–Q3, Q3–Q9) in the SG (P = 0.72). The conditions of four patients from the AG worsened (16.6%), and they underwent surgery. Three patients from the SG required reoperation. No difference was found between the two groups regarding minor amputations (P = 0.336).
Conclusions: Antibiotic therapy and surgical treatment had similar outcomes in terms of healing rates, time to healing, and short-term complications in patients with neuropathic forefoot ulcers complicated by osteomyelitis without ischemia or necrotizing soft tissue infections.
Osteomyelitis in the feet of patients with diabetes is one of the most controversial issues when dealing with diabetic foot syndrome. It is generally accepted that bacteria reach the bone by first involving soft tissue and then involving cortical bone and/or the bone marrow. The diagnosis can be a challenge and may require advanced imaging studies in some cases. However, definitive diagnosis requires removing bone samples for both microbiological and histopathological studies.
The choice of treatment is based on the anatomical site of infection, the local vascular supply, the extent of soft tissue and bone destruction, the presence of necrosis, systemic signs of infection, and the clinician's and patient's preferences. The optimum approach is currently being debated, and the definitive role of surgery and antibiotic treatment is not sufficiently well clarified.
Several retrospective studies have reported good results when treating diabetic foot osteomyelitis (DFO) exclusively with antibiotics for a variable period However, these studies have been criticized because the remission of inflammatory signs, "apparent remission," or limb salvage are not appropriate end points for demonstrating that the bone infection has actually been eradicated. Additionally, previous studies have been criticized because DFO was not diagnosed by bone biopsy, there was no comparator group, or long-term follow-up was lacking in most patients.
The main advantage of treating DFO with antibiotics is that it reduces the biomechanical changes that occur in the feet after surgical procedures, and avoids the financial cost and potential medical/surgical complications of surgical procedures, although it remains to be demonstrated that using primarily nonsurgical treatment is a more cost-effective approach. However, studies using antibiotics exclusively have failed to demonstrate this because short-term and mid-term follow-up was not carried out. On the other hand, the biomechanical disturbance that was the cause of the index ulcer would remain as it was, becoming a risk zone after successful antibiotic treatment. Finally, when antibiotic therapy alone is chosen to treat DFO, one cannot predict with certainty the patients in whom medical therapy will fail, and failure could be associated with a more proximal level of amputation.
Surgery has been used for many years and is the mainstay of treatment of DFO. Several authors have reported the efficacy of surgical treatment of osteomyelitis Furthermore, the development of conservative surgery to remove the bone infection while avoiding amputation is an attractive option. However, surgery, including conservative procedures, leads to biomechanical changes and reulceration due to pressure transfer syndrome, even though removing a bone deformity could have a prophylactic effect. According to a recent report, conservative surgery could also reduce the period of antibiotic therapy with a high rate of limb salvage.
It is very difficult to compare a series treating patients with antibiotics with a series consisting of surgically treated patients for several reasons: different end points were used; the characteristics of patients included in the series differed; the studies were carried out in different clinical settings; and histopathological confirmation of bone infection is not usually carried out.
The aim of the current study was to compare the outcomes of the treatment of DFO in patients treated exclusively with antibiotics to those of patients who underwent conservative surgery, following up the patients for a period of 12 weeks after healing.
Abstract and Introduction
Abstract
Objective: No prospective trials have been carried out comparing antibiotic treatment alone with primarily surgical treatment in patients with diabetes and foot osteomyelitis. The aim of the current study was to compare the outcomes of the treatment of diabetic foot osteomyelitis in patients treated exclusively with antibiotics versus patients who underwent conservative surgery, following up the patients for a period of 12 weeks after healing.
Research design and methods: Between 1 January 2010 and 31 December 2012, a prospective randomized comparative trial (clinical trial reg. no. NCT01137903,clinicaltrials.gov) of patients with diabetes who had received a diagnosis of neuropathic foot ulcers complicated by osteomyelitis was carried out at the Diabetic Foot Unit at the Complutense University of Madrid. Patients were randomized into the following two groups: the antibiotics group (AG) and the surgical group (SG). Antibiotics were given for a period of 90 days in the AG. Patients in the SG received conservative surgery with postoperative antibiotic treatment for 10 days.
Results: Eighteen patients (75%) achieved primary healing in the AG, and 19 (86.3%) in the SG (P = 0.33). The median time to healing was 7 weeks (quartile [Q] 1 to Q5, Q3–Q8) in the AG and 6 weeks (Q1–Q3, Q3–Q9) in the SG (P = 0.72). The conditions of four patients from the AG worsened (16.6%), and they underwent surgery. Three patients from the SG required reoperation. No difference was found between the two groups regarding minor amputations (P = 0.336).
Conclusions: Antibiotic therapy and surgical treatment had similar outcomes in terms of healing rates, time to healing, and short-term complications in patients with neuropathic forefoot ulcers complicated by osteomyelitis without ischemia or necrotizing soft tissue infections.
Introduction
Osteomyelitis in the feet of patients with diabetes is one of the most controversial issues when dealing with diabetic foot syndrome. It is generally accepted that bacteria reach the bone by first involving soft tissue and then involving cortical bone and/or the bone marrow. The diagnosis can be a challenge and may require advanced imaging studies in some cases. However, definitive diagnosis requires removing bone samples for both microbiological and histopathological studies.
The choice of treatment is based on the anatomical site of infection, the local vascular supply, the extent of soft tissue and bone destruction, the presence of necrosis, systemic signs of infection, and the clinician's and patient's preferences. The optimum approach is currently being debated, and the definitive role of surgery and antibiotic treatment is not sufficiently well clarified.
Several retrospective studies have reported good results when treating diabetic foot osteomyelitis (DFO) exclusively with antibiotics for a variable period However, these studies have been criticized because the remission of inflammatory signs, "apparent remission," or limb salvage are not appropriate end points for demonstrating that the bone infection has actually been eradicated. Additionally, previous studies have been criticized because DFO was not diagnosed by bone biopsy, there was no comparator group, or long-term follow-up was lacking in most patients.
The main advantage of treating DFO with antibiotics is that it reduces the biomechanical changes that occur in the feet after surgical procedures, and avoids the financial cost and potential medical/surgical complications of surgical procedures, although it remains to be demonstrated that using primarily nonsurgical treatment is a more cost-effective approach. However, studies using antibiotics exclusively have failed to demonstrate this because short-term and mid-term follow-up was not carried out. On the other hand, the biomechanical disturbance that was the cause of the index ulcer would remain as it was, becoming a risk zone after successful antibiotic treatment. Finally, when antibiotic therapy alone is chosen to treat DFO, one cannot predict with certainty the patients in whom medical therapy will fail, and failure could be associated with a more proximal level of amputation.
Surgery has been used for many years and is the mainstay of treatment of DFO. Several authors have reported the efficacy of surgical treatment of osteomyelitis Furthermore, the development of conservative surgery to remove the bone infection while avoiding amputation is an attractive option. However, surgery, including conservative procedures, leads to biomechanical changes and reulceration due to pressure transfer syndrome, even though removing a bone deformity could have a prophylactic effect. According to a recent report, conservative surgery could also reduce the period of antibiotic therapy with a high rate of limb salvage.
It is very difficult to compare a series treating patients with antibiotics with a series consisting of surgically treated patients for several reasons: different end points were used; the characteristics of patients included in the series differed; the studies were carried out in different clinical settings; and histopathological confirmation of bone infection is not usually carried out.
The aim of the current study was to compare the outcomes of the treatment of DFO in patients treated exclusively with antibiotics to those of patients who underwent conservative surgery, following up the patients for a period of 12 weeks after healing.