Non-surgical management of osteomyelitis in the diabetic foot

NewsBot · Jan 10, 2008

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OUTCOME OF DIABETIC FOOT OSTEOMYELITIS TREATED NON-SURGICALLY: A RETROSPECTIVE COHORT STUDY
Eric Senneville, Audrey Lombart, Eric Beltrand, Michel Valette, Laurence Legout, Marie Cazaubiel, Yazdan Yazdanpanah and Pierre Fontaine
Diabetes Care Publish Ahead of Print published online ahead of print January 9, 2008

Objective: To identify criteria predictive of remission in non-surgical treatment of diabetic foot osteomyelitis.

Research Design And Methods: Diabetic patients were identified who were initially treated without orthopedic surgery for osteomyelitis of the toe or metatarsal head of a non-ischemic foot, between June 2002 and June 2003 in 9 French diabetic foot centers, and their medical records were reviewed. Remission was defined as the absence of any sign of infection at the initial or contiguous site assessed at least one year after the end of treatment. A total of 24 demographic, clinical and therapeutic variables including bone versus swab-culture-based antibiotic therapy were analyzed.

Results: Fifty consecutive patients with a mean age of 62.2 ± 11.1 years and mean diabetes duration of 16 ± 10.9 years were included. The mean duration of antibiotic treatment was 11.5 ± 4.21 weeks. Bone biopsy was routinely available in 4 of the 9 centers. Overall patient management was similar in the different centers except for the use of rifampin, which was recorded more frequently in patients from centers where bone biopsy was available. At the end of a 12.8 month post-treatment mean follow-up, 32 patients (64%) were in remission. Bone-culture-based antibiotic therapy was the only variable associated with remission, as determined by both univariate [18/32 (56.3%) vs. 4/18 (22.2%), P=0.02] and multivariate analysis (OR 4.78, 95% IC 1.0-22.7, P=0.04).

Conclusions: Bone-culture-based antibiotic therapy is a factor predictive of success in diabetic patients treated non-surgically for osteomyelitis of the foot.
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NewsBot · Apr 4, 2008

Primarily non-surgical management of osteomyelitis of the foot in diabetes.
Game FL, Jeffcoate WJ.
Diabetologia. 2008 Apr 3 [Epub ahead of print]

AIMS/HYPOTHESIS: We examined the use of surgery and assessed the response to non-surgical management of osteomyelitis of the foot in diabetic patients. METHODS: We reviewed the records of all patients presenting to a single specialist centre with osteomyelitis complicating a diabetic foot ulcer over a 5 year period. Details were extracted on antibiotic choice and treatment duration, hospital admission, incidence of minor and major amputation, and 12 month outcomes.

RESULTS: There were 147 patients, with mean age 64.7 years (66% men). Of these, 26 (18%) were admitted to hospital at the time of presentation and managed with intravenous antibiotics; the remainder were managed with oral antibiotics as outpatients. Surgery was undertaken because of life- or limb-threatening infection, or failure to respond, in 34 (23%) patients (minor amputation 28, major amputation six patients). The remaining 113 were managed non-surgically. Remission was induced in 66 (58.4% of 113), while 35 (31%) had a relapse. Of those experiencing relapse, 27 (77%) achieved apparent arrest of the infection with a further course of antibiotics; six underwent minor and two underwent major amputation. Of all 113 whose infection was initially managed without surgery, apparent remission was achieved with antibiotics alone in 93 (82.3%).

CONCLUSIONS/INTERPRETATION: As these observations were made in an unselected case series, they give more insight into the respective roles of surgical and non-surgical management. The results confirm that although urgent surgery is indicated in some patients, non-surgical management of those without limb-threatening infection is associated with a high rate of apparent remission.
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NewsBot · Apr 22, 2008

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OUTCOME OF DIABETIC FOOT OSTEOMYELITIS TREATED NON-SURGICALLY: A RETROSPECTIVE COHORT STUDY
Eric Senneville, Audrey Lombart, Eric Beltrand, Michel Valette, Laurence Legout, Marie Cazaubiel, Yazdan Yazdanpanah and Pierre Fontaine
Diabetes Care Publish Ahead of Print published online ahead of print January 9, 2008
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Reuters have a press release on this paper:
Bone biopsy can help treat diabetic foot infection

A biopsy of the bone can help doctors determine what antibiotic is the best to use in treating diabetic patients with serious foot infections, according to findings published in the journal Diabetes Care. This approach may help patients avoid surgery.

Due to circulation problems and decreased nerve sensation, diabetics are at increased risk for foot injuries that can go unnoticed. What may start as a simple blister can soon spiral into a serious skin infection, including one that extends down to the bone, referred to as osteomyelitis.

"The question of surgical versus nonsurgical treatment for diabetic patients with osteomyelitis of the foot remains subject to debate," Dr. Eric Senneville, of Dron Hospital, Tourcoing, France, and colleagues write. It has usually been though that these infections could not be successfully treated without removing a portion of the infected bone.

In the present study, the authors reviewed the medical records of 50 diabetic patients who were treated without surgery for osteomyelitis of various foot bones at 9 French diabetic foot centers. Among the various research questions addressed was whether a bone biopsy was better than a simple skin swab to determine the best antibiotic to combat the infection.

On average, the study subjects were 62 years old and had been diabetic for about 16 years. The average wound duration was 20 weeks, and the average duration of antibiotic treatment was 11.5 weeks. Overall, 22 patients (44 percent) underwent bone biopsy-based therapy, and 28 (56 percent) had swab-based therapy.

Success was defined as the absence of any sign of infection at the initial or a contiguous site at least 1 year after the end of treatment.

After an average follow-up of 12.8 months, success was achieved in 18 (81.8 percent) patients treated on the basis of bone culture results and in 14 (50 percent) of patients with swab-based therapy, the researchers report.

"Our results provide arguments for recommending the use of bone biopsy in diabetic patients treated nonsurgically for osteomyelitis of the foot," the team concludes
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NewsBot · Jan 11, 2020

A multicenter randomized placebo controlled trial of rifampin to reduce pedal amputations for osteomyelitis in veterans with diabetes (VA INTREPID).
Bessesen MT et al
BMC InfectDis. 2020 Jan 8;20(1):23

BACKGROUND:
The prevalence of diabetes mellitus continues to inexorably rise in the United States and throughout the world. Lower limb amputations are a devastating comorbid complication of diabetes mellitus. Osteomyelitis increases the risk of amputation fourfold and commonly presages death. Antimicrobial therapy for diabetic foot osteomyelitis (DFO) varies greatly, indicating that high quality data are needed to inform clinical decision making. Several small trials have indicated that the addition of rifampin to backbone antimicrobial regimens for osteomyelitis outside the setting of the diabetic foot results in 28 to 42% higher cure rates.

METHODS/DESIGN:
This is a prospective, randomized, double-blind investigation of the addition of 6 weeks of rifampin, 600 mg daily, vs. matched placebo (riboflavin) to standard-of-care, backbone antimicrobial therapy for DFO. The study population are patients enrolled in Veteran Health Administration (VHA), ages ≥18 and ≤ 89 years with diabetes mellitus and definite or probable osteomyelitis of the foot for whom an extended course of oral or intravenous antibiotics is planned. The primary endpoint is amputation-free survival. The primary hypothesis is that using rifampin as adjunctive therapy will lower the hazard rate compared with the group that does not use rifampin as adjunctive therapy. The primary hypothesis will be tested by means of a two-sided log-rank test with a 5% significance level. The test has 90% power to detect a hazard ratio of 0.67 or lower with a total of 880 study participants followed on average for 1.8 years.

DISCUSSION:
VA INTREPID will test if a rifampin-adjunctive antibiotic regimen increases amputation-free survival in patients seeking care in the VHA with DFO. A positive finding and its adoption by clinicians would reduce lower extremity amputations and their associated physical and emotional impact and reduce mortality for Veterans and for the general population with diabetic foot osteomyelitis. Given that rifampin-adjunctive regimens are currently employed for therapy for the majority of DFO cases in Europe, and only in a small minority of cases in the United States, the trial results will impact therapeutic decisions, even if the null hypothesis is not rejected.
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NewsBot · Jun 3, 2020

Adjunctive rifampin therapy for diabetic foot osteomyelitis
A protocol for systematic review and meta-analysis
Zhang, Yanli SD; Wang, Shengju MD; Liu, Min SD; Yao, Shasha SD; Fang, Song SD; Cheng, Haiping SD; Chen, Qiu MD∗Author Information
Medicine: May 29, 2020 - Volume 99 - Issue 22 - p e20375

Introduction:
The prevalence of diabetes continues to rise around the world. Diabetic foot is a serious complication of diabetes, and diabetic patients with diabetic foot osteomyelitis (DFO) have a fourfold increased risk of amputation, usually indicating death. Therefore, it is particularly important to seek a more effective treatment for DFO. The treatment of DFO varies from person to person, and antimicrobial therapies vary widely. A large number of clinical studies have shown that rifampicin adjuvant therapy can reduce the rate of amputation and mortality in DFO patients. However, there is no systematic summary of clinical evidence, which limits the clinical application of rifampicin. Therefore, we attempted to provide high-quality evidence for the clinical efficacy and safety of rifampin in the adjuvant treatment of DFO through this meta-analysis.

Methods:
English literature is mainly searched in Cochrane Library, PubMed, EMBASE and Web of Science, while Chinese literature is from CNKI, CBM, VIP and Wangfang databases. At the same time, we will search clinical registration tests and gray literature. Two methodologically trained researchers will read the title, abstract, and full text, and independently select qualified literature based on inclusion and exclusion criteria. Binary data is expressed as relative risk, continuous data is expressed as mean difference or standard mean difference. The final data are synthesized using a fixed effect model or a random effect model, depending on the presence of heterogeneity. In the end, the patient's amputation rate and mortality were the main research indicators. Survival rate, HbA1c, serum creatinine, changes in ulcer area, and SF-36 quality of life assessment were used as secondary indicators. We will perform a sensitivity analysis to assess the stability of the results. Then the publication bias was evaluated by funnel plot analysis and Egger test. Finally, we will use a “recommendation grading, evaluation, formulation and evaluation” system to assess the quality of the evidence. All data analysis will be meta-analyzed by the statistical software RevMan software version 5.3.

Results:
This study will provide a high-quality comprehensive report on the effectiveness and safety of rifampicin in the treatment of DFO, and our findings will be published in peer-reviewed journals.

Conclusion:
This systematic review and meta-analysis will provide a comprehensive summary and careful evaluation of rifampicin as an adjuvant treatment of DFO with a view to providing multiple options for clinical treatment of the disease.
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NewsBot · Mar 8, 2021

Conservative surgery for chronic diabetic foot osteomyelitis: Procedures and recommendations
José Luis Lázaro-Martínez et al
J Clin Orthop Trauma. 2020 Dec 15

Osteomyelitis (OM) is the most frequent infection associated with diabetic foot ulcers (DFU) that typically involve the forefoot, the most common location of DFU. Conservative surgical procedures could be attractive alternative that reduces minor and major amputations and avoid future recurrence thus preserving the functionally of the foot. This review aimed to analyze and describe the current evidence on conservative diabetic foot osteomyelitis (DFO) surgical procedures depending on DFU location and indications. A narrative revision of the evidence was carried out by searching Medline through PubMed databases from inception to late July 2020 to identify retrospective, prospective, and randomized controlled trials pertaining to conservative DFO procedures on the forefoot. Seven types of conservative surgical procedures for DFO treatment in the forefoot are described in this review: (1) partial or total distal phalangectomy, (2) arthroplasty of the proximal or distal interphalangeal joint, (3) distal Syme amputation, (4) percutaneous flexor tenotomy, (5) sesamoidectomy, (6) arthroplasty of the metatarsophalangeal joint, and (7) metatarsal head resection. When indicated, conservative surgery for DFUs in patients with chronic forefoot OM is a safe and effective option that increases the chances of healing and reduces the possibility of limb loss and death compared with radical amputation procedures. Since a lack of sufficient evidence supporting this procedure exists, future investigations should be focused on the random clinical trial (RCT) design. The results of prospective trials could help surgeons select the appropriate procedure in each case in order to minimize complications.
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NewsBot · Aug 8, 2021

Complex Foot Infection Treated With Surgical Debridement and Antibiotic Loaded Calcium Sulfate—A Retrospective Cohort Study of 137 Cases
Robert Morley, MSc et al
JFAS: July 22, 2021

Complex foot infections involving bone and soft tissue in patients with co-morbidities such as diabetes and peripheral arterial disease (PAD) are a cause of significant hospital admission. They are associated with substantial economic costs to health services worldwide. Historically, severe foot infection has been treated with surgical debridement and prolonged courses of systemic antibiotics. Prolonged systemic antibiotic use increases the risk of drug side effects, antimicrobial resistance and Clostridium difficile infection. The purpose of this study was to investigate whether surgical debridement and implantation of antibiotic loaded calcium sulfate is effective in the resolution of foot infection and wound healing. A retrospective cohort study of 137 consecutive cases of osteomyelitis (127) or significant soft tissue infection (10) over 62 months from 02/2013 to 04/2018 was conducted following local ethical approval. All cases of infection were treated with surgical debridement and local antibiotic-loaded calcium sulfate. The primary outcomes of infection resolution, time to healing and duration of postoperative antibiotics were measured. In 137 cases, 88.3% of infections resolved. Infection was eradicated in 22 patients without postoperative systemic antibiotics. About 82.5% of wounds healed, with an average healing time of 11.3 weeks. Healing time was significantly increased for the co-morbidities of diabetes and PAD (p =< .05) and for those requiring prolonged systemic postoperative antibiotics. Conservative surgical debridement and implantation of local antibiotic impregnated calcium sulfate is safe and effective in managing complex foot infections. We advocate early surgical intervention before deeper tissue involvement to help preserve lower limb structure and function.
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NewsBot · Nov 5, 2021

Antibiotic-Impregnated Calcium Sulfate vs. Wound Irrigation-Suction to Treat Chronic Calcaneal Osteomyelitis
Lei Xu et al
Foot Ankle Int. 2021 Nov 1

Background: Chronic osteomyelitis of calcaneus is not rare but is very hard to treat. Irrigation-suction and antibiotic-impregnated calcium sulfate following debridement are commonly used in managing chronic osteomyelitis, but their effects have rarely been compared. We aimed to compare the effectiveness of antibiotic-impregnated calcium sulfate with irrigation-suction in the treatment of patients with chronic calcaneal osteomyelitis.

Methods: From January 2011 to June 2018, adult patients at our institute with chronic osteomyelitis receiving treatment of either antibiotic-impregnated calcium sulfate (CS group) or irrigation-suction (IS group) following thorough debridement were screened and selected according to the inclusion and exclusion criteria. The clinical presentation, laboratory tests, complications, and the ultimate single-staged cure rate and recurrence were compared.

Results: A total of 61 patients, including 41 in the CS group and 20 in the IS group, were included in our study. Of the patients, 85.4% in the CS group and 60.0% in the IS group (P = .006) were successfully cured in the single stage, respectively, without infection recurrence. Lower infection recurrence rates with shorter hospital stay were found in the CS group than the IS group. Inflammatory biomarkers after surgery with both treatments were slightly decreased and not significantly different from preoperative or between-groups postoperative. Exudate from incision was found primarily in the CS group.

Conclusion: This study demonstrates that both antibiotic-impregnated calcium sulfate and irrigation-suction after careful and thorough surgical debridement are generally effective in treating chronic calcaneal osteomyelitis. Antibiotic-impregnated calcium sulfate achieved a higher single-staged cure rate but was associated with an increased postoperative wound exudate.
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NewsBot · Dec 27, 2021

Oral Versus Intravenous Antibiotics for Residual Osteomyelitis After Amputation in the Diabetic Foot
Ankurpreet Singh Gill et al
J Foot Ankle Surg. 2021 Nov 23

The standard management for residual osteomyelitis following amputation in a diabetic foot infection includes a prolonged course of intravenous antibiotic agents. The purpose of this analysis was to investigate whether oral antibiotic therapy led to treatment failure more than intravenous antibiotic therapy for this indication. The primary endpoint was treatment failure within one year of the initial amputation, defined by re-operation for residual osteomyelitic infection or a remaining nonhealing wound at the surgical site. All patients received at least 4 weeks of antibiotics and were chosen for oral or intravenous route of administration by infectious disease specialists. Characteristics including age, sex, hemoglobin A1c, BMI, tobacco use, PVD, homelessness and IDSA classification were also assessed for influence on antibiotic success and failure. Of the 65 patients meeting inclusion criteria, treatment failure occurred in 32 and treatment success occurred in 33. Of the treatment failures, 17 (53%) were in the intravenous group, and 15 (47%) were in the oral group. The differences between the modalities of antibiotic administration and their failure rates were not found to be statistically significant (p = .28 (proportional difference: -14%, 95% confidence interval [CI]:-36% to 10%)).
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NewsBot · Jun 8, 2022

Intravenous vs. Oral Antibiotics for Nonhematogenous
Osteomyelitis: A Review
Tal Boussi B.S. and Aleksa Martin B.S.
Extremitas

Objective: The objective of this review is to assess studies which compare the efficacy of oral antibiotics to
intravenous antibiotics for the treatment of nonhematogenous osteomyelitis.
Methods: A search on PubMed was conducted to isolate studies from the past twenty years, 2001–21, which focused
on oral and intravenous antibiotic therapy in cases of nonhematogenous osteomyelitis.
Results: Three studies were selected for review. A randomized open-label trial by Lipsky et al. compared oral linezolid
with intravenous aminopenicillin/beta-lactamase-inhibitors for treatment in patients with various severities of diabetic
foot infections. A retrospective study by Embil et al. evaluated cases of nonhematogenous osteomyelitis of the foot
treated with oral antibiotics plus or minus debridement. Li et al. conducted a noninferiority trial which evaluated the
one-year post-therapy outcomes of intravenous antibiotic therapy versus oral antibiotic therapy for osteomyelitis when
given in the first six weeks of treatment.
Conclusion: There is a noninferiority to the use of oral antibiotics when compared to intravenous therapy for treating
nonhematogenous osteomyelitis.
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NewsBot · Dec 17, 2023

Outcome of Chronic Foot Osteomyelitis Treated With Hyperbaric Oxygen: An Observational Study
Serdar Menekse
Int J Low Extrem Wounds. 2023 Dec 10

Chronic refractory osteomyelitis of the foot stands as a formidable challenge in medical care, associated with significant morbidity and escalating healthcare costs. Traditional therapeutic approaches, including surgical debridement and systemic antibiotics, often fall short, leaving patients and clinicians in search of more efficacious interventions. Hyperbaric oxygen therapy (HBOT), an innovative therapeutic modality, has recently emerged as a promising adjunct therapy, offering a beacon of hope in this therapeutic conundrum. In this groundbreaking observational study, we meticulously analyzed the experiences of 80 patients suffering from chronic refractory osteomyelitis of the foot. Following surgical debridement and tailored antibiotic therapy, each patient was treated with HBOT at 2.5 atmospheres absolute for 120 min, 5 days a week, spanning an average of 50 days. Our primary endpoints focused on complete eradication of infection, recurrence metrics, and any adverse effects linked to HBOT. Astonishingly, 68 of the 80 patients (85%) achieved a total infection clearance, maintaining this status through a mean follow-up period of 36 months, all without a single report of HBOT-induced complications. Our compelling findings advocate that HBOT, synergized with standard surgical and antibiotic regimens, can revolutionize the treatment landscape for chronic refractory osteomyelitis of the foot. Given these promising preliminary results, there's an imperative need for extensive research to delineate the long-term advantages and to fine-tune HBOT protocols, potentially paving the way for a new therapeutic gold standard.
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