Study Protocol: Optimization of the surgical and medical management of diabetic foot infections

Abstract Background: Few studies address the appropriate duration of antibiotic therapy for diabetic foot infections (DFI); with or without amputation. We perform two randomized clinical trials (RCT) to reduce the antibiotic use and associated adverse events in DFI. Methods: We hypothesize that shorter durations of post-debridement systemic antibiotic therapy are non-inferior (10% margin, 80% power, ɑ 5%) to existing (long) durations and perform two unblinded RCTs with a total of 400 DFI episodes (randomization 1:1) from 2019 to 2022. The primary outcome for both RCT is “remission of infection” after a minimal follow-up of two months. The 1 st RCT allocates the amputations in two arms of 50 patients each: 1 vs. 3 weeks of antibiotic therapy for residual osteomyelitis (positive microbiological samples of the residual bone stump); or 1 vs. 4 days for remaining soft tissue infection. The 2 nd RCT randomizes the conservative approach in two arms with 50 patients each: 10 vs. 20 days of antibiotic therapy for soft tissue infections; and 3 vs. 6 weeks for osteomyelitis. All participants have professional wound debridement, adequate off-loading, angiology evaluation, and a concomitant surgical, re-educational, internist and infectiology care. During the surgeries, we collect tissues for BioBanking and future laboratory studies. Discussion: Both parellel RCT will enable to prescribe less antibiotics for DFI; for a conservative therapy and after amputation. Trial registration: ClinicalTrial.gov NCT04081792. Registered on 4 th September 2019. Protocol version : 2 (15 th July 2019)

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Optimization of the antibiotic management of diabetic foot infections - Protocol for two randomized controlled trials

10.21203/rs.2.15844/v2 ◽

2019 ◽

Author(s):

Felix WA Waibel ◽

Martin Berli ◽

Sabrina Catanzaro ◽

Kati Sairanen ◽

Madlaina Schöni ◽

...

Keyword(s):

Soft Tissue ◽

Adverse Events ◽

Antibiotic Therapy ◽

Diabetic Foot ◽

Randomized Clinical Trials ◽

Antibiotic Use ◽

Wound Debridement ◽

Diabetic Foot Infections ◽

Systemic Antibiotic Therapy ◽

Antibiotic Management

Abstract Background: Few studies address the appropriate duration of antibiotic therapy for diabetic foot infections (DFI); with or without amputation. We will perform two randomized clinical trials (RCT) to reduce the antibiotic use and associated adverse events in DFI. Methods: We hypothesize that shorter durations of post-debridement systemic antibiotic therapy are non-inferior (10% margin, 80% power, ɑ 5%) to existing (long) durations and we will perform two unblinded RCTs with a total of 400 DFI episodes (randomization 1:1) from 2019 to 2022. The primary outcome for both RCT is “remission of infection” after a minimal follow-up of two months. The secondary outcomes for both RCT are the incidence of adverse events and the overall treatment costs. The First RCT will allocate the total therapeutic amputations in two arms of 50 patients each: 1 vs. 3 weeks of antibiotic therapy for residual osteomyelitis (positive microbiological samples of the residual bone stump); or 1 vs. 4 days for remaining soft tissue infection. The Second RCT will randomize the conservative approach (only surgical debridement without in toto amputation) in two arms with 50 patients each: 10 vs. 20 days of antibiotic therapy for soft tissue infections; and 3 vs. 6 weeks for osteomyelitis. All participants will have professional wound debridement, adequate off-loading, angiology evaluation, and a concomitant surgical, re-educational, podiatric, internist and infectiology care. During the surgeries, we will collect tissues for BioBanking and future laboratory studies. Discussion: Both parellel RCTs will repond to frequent questions regarding the duration of antibiotic use in the both major subsets of DFIs, to assure the quality of care, and to avoid unnecessary excesses in terms of surgery and antibiotic use. Trial registration: ClinicalTrial.gov NCT04081792. Registered on 4th September 2019. Protocol version: 2 (15th July 2019)

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Optimization of the antibiotic management of diabetic foot infections: protocol for two randomized controlled trials

Trials ◽

10.1186/s13063-019-4006-z ◽

2020 ◽

Vol 21 (1) ◽

Cited By ~ 1

Author(s):

Felix Waibel ◽

Martin Berli ◽

Sabrina Catanzaro ◽

Kati Sairanen ◽

Madlaina Schöni ◽

...

Keyword(s):

Soft Tissue ◽

Adverse Events ◽

Antibiotic Therapy ◽

Diabetic Foot ◽

Randomized Clinical Trials ◽

Antibiotic Use ◽

Wound Debridement ◽

Diabetic Foot Infections ◽

Systemic Antibiotic Therapy ◽

Antibiotic Management

Abstract Background Few studies have addressed the appropriate duration of antibiotic therapy for diabetic foot infections (DFI) with or without amputation. We will perform two randomized clinical trials (RCTs) to reduce the antibiotic use and associated adverse events in DFI. Methods We hypothesize that shorter durations of postdebridement systemic antibiotic therapy are noninferior (10% margin, 80% power, alpha 5%) to existing (long) durations and we will perform two unblinded RCTs with a total of 400 DFI episodes (randomization 1:1) from 2019 to 2022. The primary outcome for both RCTs is remission of infection after a minimal follow-up of 2 months. The secondary outcomes for both RCTs are the incidence of adverse events and the overall treatment costs. The first RCT will allocate the total therapeutic amputations in two arms of 50 patients each: 1 versus 3 weeks of antibiotic therapy for residual osteomyelitis (positive microbiological samples of the residual bone stump); or 1 versus 4 days for remaining soft tissue infection. The second RCT will randomize the conservative approach (only surgical debridement without in toto amputation) in two arms with 50 patients each: 10 versus 20 days of antibiotic therapy for soft tissue infections; and 3 versus 6 weeks for osteomyelitis. All participants will have professional wound debridement, adequate off-loading, angiology evaluation, and a concomitant surgical, re-educational, podiatric, internist and infectiology care. During the surgeries, we will collect tissues for BioBanking and future laboratory studies. Discussion Both parallel RCTs will respond to frequent questions regarding the duration of antibiotic use in the both major subsets of DFIs, to ensure the quality of care, and to avoid unnecessary excesses in terms of surgery and antibiotic use. Trial registration ClinicalTrials.gov, NCT04081792. Registered on 4 September 2019.

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Topical Application of a Gentamicin-Collagen Sponge Combined with Systemic Antibiotic Therapy for the Treatment of Diabetic Foot Infections of Moderate Severity

Journal of the American Podiatric Medical Association ◽

10.7547/1020223 ◽

2012 ◽

Vol 102 (3) ◽

pp. 223-232 ◽

Cited By ~ 26

Author(s):

Benjamin A. Lipsky ◽

Michael Kuss ◽

Michael Edmonds ◽

Alexander Reyzelman ◽

Felix Sigal

Keyword(s):

Treatment Group ◽

Antibiotic Therapy ◽

Diabetic Foot ◽

Clinical Cure ◽

Standard Of Care ◽

Collagen Sponge ◽

Control Group ◽

Moderate Severity ◽

Diabetic Foot Infections ◽

Systemic Antibiotic Therapy

Background: The aim of this pilot study was to determine the safety and potential benefit of adding a topical gentamicin-collagen sponge to standard of care (systemic antibiotic therapy plus standard diabetic wound management) for treating diabetic foot infections of moderate severity. Methods: We randomized 56 patients with moderately infected diabetic foot ulcers in a 2:1 ratio to receive standard of care plus the gentamicin-collagen sponge (treatment group, n = 38) or standard of care only (control group, n = 18) for up to 28 days of treatment. Investigators performed clinical, microbiological, and safety assessments at regularly scheduled intervals and collected pharmacokinetic samples from patients treated with the gentamicin-collagen sponge. Test of cure was clinically assessed 14 days after all antibiotic therapy was stopped. Results: On treatment day 7, we noted clinical cure in no treatment patients and three control patients (P = .017). However, for evaluable patients at the test-of-cure visit, the treatment group had a significantly higher proportion of patients with clinical cure than did the control group (22 of 22 [100.0%] versus 7 of 10 [70.0%]; P =.024). Patients in the treatment group also had a higher rate of eradication of baseline pathogens at all visits (P ≤ .038) and a reduced time to pathogen eradication (P < .001). Safety data were similar for both groups. Conclusions: Topical application of the gentamicin-collagen sponge seems safe and may improve clinical and microbiological outcomes of diabetic foot infections of moderate severity when combined with standard of care. These pilot data suggest that a larger trial of this treatment is warranted. (J Am Podiatr Med Assoc 102(3): 223-232, 2012)

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320. Does Guideline-Based Management of Diabetic Foot Osteomyelitis Reduce Risk of Further Proximal Amputations?

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.516 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S232-S232

Author(s):

Eugene Lee ◽

Jakrapun Pupaibool ◽

Laura Certain

Keyword(s):

Antibiotic Therapy ◽

Diabetic Foot ◽

Primary Outcome ◽

Adherence To Guidelines ◽

Diabetic Foot Infections ◽

Significant Difference ◽

Antibiotic Management ◽

Reduce Risk ◽

Reduced Risk ◽

Diabetic Foot Osteomyelitis

Abstract Background The antibiotic management of diabetic foot osteomyelitis involving surgical limb-sparing amputation is controversial. While there are several guidelines that provide recommendations regarding antibiotic therapy for diabetic foot osteomyelitis after amputation, we do not know of any studies that show that adherence to guidelines improves clinical outcomes. We assessed whether adherence to antibiotic choice and duration in accordance with our institution’s guidelines, which are based on IDSA guidelines, reduced risk of future amputations. Methods We conducted a retrospective cohort study of 110 patients with diabetic foot osteomyelitis treated with limb-sparing amputations at a VA hospital. We collected relevant clinical data such as patient comorbidities, antibiotic allergies, labs, imaging, culture data, histopathologic reports, pre-op and post-op antibiotics. We used our institutional guidelines, which are based on the 2012 IDSA Guidelines for the Diagnosis and Treatment of Diabetic Foot Infections, to assess antibiotic choice and duration for diabetic foot osteomyelitis therapy after amputation. We stratified cases as either adherent or non-adherent based on whether antibiotic choice and duration were both in accordance with our institutional guideline. For each case, we recorded the primary outcome of further proximal amputation occurring within six months or death from all causes within three months. Results We found a significant difference in primary outcomes between the groups that were treated with antibiotics adherent with guidelines and antibiotics non-adherent with guidelines. For patients who were treated with antibiotics that were non-adherent to guidelines, 15 of 36 (42%) patients needed further amputation or died. Of the patients treated according to guidelines, 12 of 74 (16%) patients needed further amputation or died. There was a statistically significant difference between these two groups (p=0.004). Conclusion Our study showed that guideline-based antibiotic therapy for diabetic foot osteomyelitis treated with amputation significantly lowered rates of further amputation compared to antibiotic therapies that were not adherent to guidelines. Disclosures All Authors: No reported disclosures

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Punch Grafting for the Management of Hard-to-Heal Diabetic Foot Ulcers: A Prospective Case Series

The International Journal of Lower Extremity Wounds ◽

10.1177/15347346211031085 ◽

2021 ◽

pp. 153473462110310

Author(s):

Marta García-Madrid ◽

Irene Sanz-Corbalán ◽

Aroa Tardáguila-García ◽

Raúl J. Molines-Barroso ◽

Mateo López-Moral ◽

...

Keyword(s):

Wound Healing ◽

Clinical Outcomes ◽

Diabetic Foot ◽

Donor Site ◽

Case Series ◽

Foot Ulcers ◽

Diabetic Foot Ulcers ◽

Wound Debridement ◽

Prospective Case Series

Punch grafting is an alternative treatment to enhance wound healing which has been associated with promising clinical outcomes in various leg and foot wound types. We aimed to evaluate the clinical outcomes of punch grafting as a treatment for hard-to-heal diabetic foot ulcers (DFUs). Six patients with chronic neuropathic or neuroischemic DFUs with more than 6 months of evolution not responding to conventional treatment were included in a prospective case series between May 2017 and December 2020. All patients were previously debrided using an ultrasound-assisted wound debridement and then, grafted with 4 to 6 mm punch from the donor site that was in all cases the anterolateral aspect of the thigh. All patients were followed up weekly until wound healing. Four (66.7%) DFUs were located in the heel, 1 (16.7%) in the dorsal aspect of the foot and 1 (16.7%) in the Achilles tendon. The median evolution time was 172 (interquartile range [IQR], 25th-75th; 44-276) weeks with a median area of 5.9 (IQR; 1.87-37.12) cm2 before grafting. Complete epithelization was achieved in 3 (50%) patients at 12 weeks follow-up period with a mean time of 5.67 ± 2.88 weeks. Two of the remaining patients achieved wound healing at 32 and 24 weeks, respectively, and 1 patient showed punch graft unsuccessful in adhering. The median time of wound healing of all patients included in the study was 9.00 (IQR; 4.00-28.00) weeks. The wound area reduction (WAR) at 4 weeks was 38.66% and WAR at 12 weeks was 88.56%. No adverse effects related to the ulcer were registered through the follow-up period. Autologous punch graft is an easy procedure that promotes healing, achieving wound closure in chronic DFUs representing an alternative of treatment for hard-to-heal DFUs in which conservative treatment has been unsuccessful.

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Joint Consultation Clinic by Infectious Diseases Specialists and Podiatry team (ID-POD) Compliments the Care of Diabetic Patients with Foot Infections by Reducing Cost and Decreasing Outpatient Clinic Visits

Open Forum Infectious Diseases ◽

10.1093/ofid/ofx163.776 ◽

2017 ◽

Vol 4 (suppl_1) ◽

pp. S328-S328

Author(s):

Pushpalatha Bangalore Lingegowda ◽

Say-Tat Ooi ◽

Jyoti Somani ◽

Chelsea Law ◽

Boon Kiak Yeo

Keyword(s):

Infectious Diseases ◽

Diabetic Foot ◽

Wound Care ◽

Cost Savings ◽

Outpatient Setting ◽

Multidisciplinary Teams ◽

Diabetic Patients ◽

Wound Debridement ◽

Diabetic Foot Infections ◽

Before And After

Abstract Background Management of diabetic foot infections (DFI) is challenging and involves multidisciplinary teams to improve outcomes (1). Appropriate wound care of patients with DFI plays an important role in successfully curing infections and promote wound healing. In Singapore, Infectious Diseases (ID) specialists help in the management of DFI by recommending appropriate antibiotics for infected wounds while wound debridement are managed by Podiatrists (POD). When patients are hospitalized multidisciplinary teams including Vascular Surgery review patients. In the outpatient setting patients have multiple appointments including ID and Endocrinology etc. The time spent and costs incurred by patients for traveling to multiple appointments is considerable. A joint ID-POD clinic was initiated to reduce the cost and inconvenience for patients. Methods A joint weekly clinic was initiated in October’16 and the data was analyzed upto May’17. Finance was involved in deriving costs. The service costs for consultations payable by patients before and after the initiation of the joint clinic were compared. Results First 6 months experience of initiating the joint ID-POD clinic is reported. 35 unique patients had a total of 88 visits. 1/third of the patients had more than 2 visits to the joint clinic. For each visit to the joint clinic the patient paid 25% less compared with having separate clinics. The hospital lowered the service cost for the new clinic by 11%. This was done by minimizing the time involvement of the ID physician. Conclusion Joint ID-POD clinic for managing diabetic patients with foot infections revealed several advantages. Hospital outpatient visits for each patient decreased by 50% for those requiring care of both ID and POD, without compromising care. With the consolidation of care each individual patient had a cost savings of 25% for the joint consultation. This joint clinic while making it convenient for patients has revealed significant cost savings to patients especially for those requiring multiple visits. We recommend hospitals with high prevalence of Diabetes and Diabetic foot infections to consider joint ID-POD clinics to reduce hassle and increase saving for patients. Disclosures All authors: No reported disclosures.

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