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

2012 ◽  
Vol 102 (3) ◽  
pp. 223-232 ◽  
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)

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

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)

scholarly journals Nutritional Supplementation Concurrent with Nutrition Education Accelerates the Wound Healing Process in Patients with Diabetic Foot Ulcers

Biomedicines ◽  
2020 ◽  
Vol 8 (8) ◽  
pp. 263 ◽  
Author(s):  
Raedeh Basiri ◽  
Maria T. Spicer ◽  
Cathy W. Levenson ◽  
Michael J. Ormsbee ◽  
Thomas Ledermann ◽  
...  
Keyword(s):  
Wound Healing ◽  
Treatment Group ◽  
Nutrition Education ◽  
Diabetic Foot ◽  
Healing Process ◽  
Standard Of Care ◽  
Control Group ◽  
Wound Age ◽  
Wound Area ◽  
Nutrition Supplementation

Trials on nutritional supplements for the treatment of diabetic foot ulcer (DFU) have only evaluated the effects of supplementation with specific nutrients. Additionally, nutrition education has not been a systematic part of these studies. The aim of this study was to evaluate the effects of a nutrient-dense formula combined with nutrition education on wound healing in DFU patients. Twenty-nine patients were randomly assigned to the treatment group (n = 15) receiving two servings of supplements daily plus nutrition education or control group (n = 14) that received the standard of care but no additional nutritional or educational intervention. Both groups were followed for a maximum of 12 weeks. Wound healing, as measured by planimetry, was examined at baseline and every four weeks until complete wound closure or up to 12 weeks. There were no significant differences between groups for BMI, age, duration of diabetes, wound age estimation, or wound area at baseline. The treatment group experienced a faster wound healing rate (6.43 mm2/week more reduction in the wound area) than the control group. The mean reduction in the wound area during the first four weeks of the study was almost 13-fold greater in the treatment group compared to the control group (18.0 mm2/week vs. 1.4 mm2/week, respectively). Our findings showed that nutrition supplementation plus nutrition education significantly accelerated wound healing in DFU patients compared to those who just received a standard-of-care regimen.

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

2019 ◽  
Author(s):  
Felix WA Waibel ◽  
Martin Berli ◽  
Sabrina Catanzaro ◽  
Kati Sairanen ◽  
Madlaina Schöni ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Antibiotic Therapy ◽  
Diabetic Foot ◽  
Primary Outcome ◽  
Randomized Clinical Trials ◽  
Antibiotic Use ◽  
Wound Debridement ◽  
Diabetic Foot Infections ◽  
Systemic Antibiotic Therapy

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)

scholarly journals Nutritional Intervention Improves the Dietary Intake of Essential Micronutrients in Patients with Diabetic Foot Ulcers

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 8-8
Author(s):  
Raedeh Basiri ◽  
Maria Spicer ◽  
Joseph Munoz ◽  
Bahram Arjmandi
Keyword(s):  
Wound Healing ◽  
Treatment Group ◽  
Dietary Intake ◽  
Diabetic Foot ◽  
Foot Ulcer ◽  
Standard Of Care ◽  
Nutritional Intervention ◽  
Food Sources ◽  
Control Group ◽  
Essential Nutrients

Abstract Objectives Diabetic foot ulcer (DFU) is a chronic wound and a common cause of lower limb amputation. A majority of DFU patients are suffering from undernutrition or malnutrition. The purpose of this randomized trial was to evaluate the combined effects of complete nutrition supplementation and education on the dietary intake of DFU patients. Methods A total of 29 patients with at least one grade 1 A foot ulcer based on the University of Texas Diabetic Wound Classification were assigned to the treatment or control. Aside from the standard of care for DFU, participants in the treatment group were provided with a dietary supplement twice a day between meals and were educated about consuming better food sources of essential nutrients for wound healing. The supplement provided 500 kcal of energy and at least 50% of RDA recommendations for protein, vitamin C, E, A, zinc, and copper. Participants in the control group only received standard of care for wound healing from the clinic. Dietary intake data were recorded at baseline and every four weeks up to 12 weeks or until the complete wound closure using 24-hour food recall questionnaire. Results The mean age of the study population was 53.3 ± 11.1 years. There were no significant differences in age, ethnicity, body mass index, hemoglobin A1C, duration of diabetes, wound age estimation, indicators of socioeconomic status and other factors involved in dietary intake including cultural and religious dietary restrictions, appetite problems, and previous unintentional weight loss between groups at baseline. Having routine visits with a registered dietitian was not part of the standard care for this population. When compared with RDA, dietary intake of zinc (33.2% to 89.2%, P = 0.02), copper (26% to 114%, P < 0.001), vitamins A (30.6 to 72.9, P = 0.001), C (117% to 403%, P = < 0.001), and E (7.29% to 306%, P = < 0.001) was significantly improved in the treatment group during the study period but there were no significant changes in dietary intake of protein or energy. There were also no significant changes in the dietary intake of the mentioned nutrients in the control group. Conclusions Our findings showed that the dietary intake of essential nutrients in wound healing was alarmingly low in DFU patients. Hence, nutritional intervention is essential and should be a part of routine care in this population. Funding Sources Florida State University.

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

Trials ◽  
2020 ◽  
Vol 21 (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.

scholarly journals The Influence of Diabetic Foot Exercise in Sensory Peripheral Neuropathy with Monofilament Test on Diabetes Mellitus Clients

Jurnal NERS ◽  
2020 ◽  
Vol 14 (3) ◽  
pp. 340
Author(s):  
Tintin Sukartini ◽  
Candra Panji Asmoro ◽  
Nandani Alifah
Keyword(s):  
Diabetes Mellitus ◽  
Peripheral Neuropathy ◽  
Treatment Group ◽  
Diabetic Foot ◽  
Rank Test ◽  
Control Group ◽  
Sensory Peripheral Neuropathy ◽  
Signed Rank ◽  
Wilcoxon Signed Rank Test ◽  
Signed Rank Test

Background: Peripheral neuropathy is a long-term complication that attacks the nerves and loses the sensation of protection which affects about 50% of people with diabetes mellitus (DM). Diabetic foot exercises can help blood circulation, especially in the legs or lower limbs. This researched aimed to analyze the effect of diabetic foot exercise on sensory peripheral neuropathy in DM clients.Method: The study design used quasi-experimental pre-post test with control group. Samples were 28 respondents using purposive sampling and divided into two groups of 14 respondents each. The independent variable is diabetic foot training, and the dependent variable is peripheral sensory neuropathy. Interventions are carried out 3 times a week for 4 weeks. The research instrument was Weinstein Monofilament 10 g Semmes and a diabetic foot training checklist. Data analysis using the Wilcoxon-signed rank test and Mann Whitney test with α≤0.05.Result: The Wilcoxon-signed rank test in the treatment group showed differences in sensory peripheral neuropathy after treatment (p=0,000) and no difference in the control group (p=0.564). The Mann Whitney test results showed differences in sensory peripheral neuropathy between the treatment group and the control group after treatment p=0.039.Conclusion: Diabetic foot exercises can be used as an alternative measure to improve sensory peripheral neuropathy.

Assessing Diabetic Foot Infections With the ThermoScale: A Comparative Thermometry Device Designed as a Patient Self-Screening Tool

2020 ◽  
pp. 153473462094830
Author(s):  
Laure Arts ◽  
Johan De Neve ◽  
Samira Baharlou ◽  
Nathalie Denecker ◽  
Laura Kerselaers ◽  
...  
Keyword(s):  
Temperature Measurement ◽  
Diabetic Foot ◽  
Characteristic Curve ◽  
Screening Method ◽  
Area Under The Curve ◽  
Control Group ◽  
Measurement Technology ◽  
Diabetic Patients ◽  
Home Setting ◽  
Diabetic Foot Infections

Diabetic foot infection (DFI) is an important risk factor for amputation, and late diagnosis or referral is often incriminated for poor outcome. To enable an earlier diagnosis of DFI, comparative foot thermometry has been suggested as a self-screening method for patients in a home setting. We validated the efficacy of the ThermoScale, a weighing scale outfitted with temperature sensors that allows accurate temperature measurement in both feet. Temperature differentials in DFI patients (n = 52) were compared with a control group of similar diabetic patients (n = 45) without any foot wounds. Based on these findings, we drafted a receiver operating characteristic curve to determine an area-under-the-curve of 0.8455. This value suggests that the ThermoScale, as a diagnostic test, is reasonably accurate. A cutoff value of 2.15 °C temperature difference corresponded with a sensitivity of 88.9% and a specificity of 61.5%. As wearables, portable health electronics, and telemedicine become increasingly popular, we think that comparative temperature measurement technology is valuable in improving early diagnosis of DFIs.

scholarly journals Efficacy of topical vancomycin and gentamicin loaded calcium sulfate beads or systemic antibiotics in eradicating polymicrobial biofilms isolated from diabetic foot infections within an in vitro wound model

2021 ◽  
Author(s):  
G.S. Crowther ◽  
N. Callaghan ◽  
M Bayliss ◽  
A Noel ◽  
R. Morley ◽  
...  
Keyword(s):  
Antibiotic Therapy ◽  
Systemic Therapy ◽  
Diabetic Foot ◽  
Calcium Sulfate ◽  
Antibiotic Administration ◽  
Systemic Delivery ◽  
Management Options ◽  
Diabetic Foot Infections ◽  
Wound Model

Diabetic foot ulcers are notoriously difficult to heal, with ulcers often becoming chronic, in many cases leading to amputation despite weeks or months of antibiotic therapy in addition to debridement and offloading. Alternative wound biofilm management options such as topical rather than systemic delivery of antimicrobials have been investigated by clinicians in order to improve treatment outcomes. Here, we collected blood and tissue from six subjects with diabetic foot infections, measured the concentration of antibiotics in the samples after treatment, and compared the microbiota within the tissue before treatment and after seven days of antibiotic therapy. We used an in vitro model of polymicrobial biofilm infection inoculated with isolates from the tissue we collected to simulate different methods of antibiotic administration by simulated systemic therapy or topical release from calcium sulfate beads. We saw no difference in biofilm bioburden in the models after simulated systemic therapy (representative of antibiotics used in the clinic) but we did see reductions in bioburden of between five and eight logs in five of the six biofilms that we tested with topical release of antibiotics via calcium sulfate beads. Yeast is insensitive to antibiotics and was a component of the sixth biofilm. These data support further studies of topical release of antibiotics from calcium sulfate beads in diabetic foot infections to combat the aggregate issues of infectious organisms taking the biofilm mode of growth, compromised immune involvement and poor systemic delivery of antibiotics via the bloodstream to the site of infection in patients with diabetes.

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