Background: Multiple organizations have issued guidelines to address the prevention, diagnosis, and management of diabetic foot ulcers (DFUs) based on evidence review and expert opinion. We reviewed these guidelines to identify consensus (or lack thereof) on the nature of these recommendations, the strength of the recommendations, and the level of evidence.
Methods: Ovid, PubMed, Web of Science, Cochrane Library, and Embase were searched in October 2018 using the MESH term diabetic foot, the key word diabetic foot, and the filters guideline or practice guideline. To minimize recommendations based on older literature, guidelines published before 2012 were excluded. Articles without recommendations characterized by strength of recommendation and level of evidence related specifically to DFU were also excluded. A manual search for societal recommendations yielded no further documents. Recommendations were ultimately extracted from 12 articles. Strength of evidence and strength of recommendation were noted for each guideline recommendation using the Grading of Recommendations Assessment, Development, and Evaluation system or the Centre for Evidence-Based Medicine system. To address disparate grading systems, we mapped the perceived level of evidence and strength of recommendations onto the American Heart Association guideline classification schema.
Results: Recommendations found in two or more guidelines were collected into a clinical checklist characterized by strength of evidence and strength of recommendation. Areas for future research were identified among recommendations based on minimal evidence, areas of controversy, or areas of clinical care without recommendations.
Conclusions: Through this work we developed a multidisciplinary set of DFU guidelines stratified by strength of recommendation and quality of evidence, created a clinical checklist for busy practitioners, and identified areas for future focused research. This work should be of value to clinicians, guideline-issuing bodies, and researchers. We also formulated a method for the review and integration of guidelines issued by multiple professional bodies.
Clinical recommendations for the prevention and healing of diabetic foot ulcers (DFUs) are somewhat clear. However, assessment and quantification of the mechanical stress responsible for DFU remain complex. Different pressure variables have been described in the literature to better understand plantar tissue stress exposure. This article reviews the role of pressure and shear forces in the pathogenesis of plantar DFU.
We performed systematic searches of the PubMed and Embase databases, completed by a manual search of the selected studies. From 535 potentially relevant references, 70 studies were included in the full-text review.
Variables of plantar mechanical stress relate to vertical pressure, shear stress, and temporality of loading. At this time, in-shoe peak plantar pressure (PPP) is the only reliable variable that can be used to prevent DFU. Although it is a poor predictor of in-shoe PPP, barefoot PPP seems complementary and may be more suitable when evaluating patients with diabetes mellitus and peripheral neuropathy who seem noncompliant with footwear. An in-shoe PPP threshold value of 200 kPa has been suggested to prevent DFU. Other variables, such as peak pressure gradient and peak maximal subsurface shear stress and its depth, seem to be of additional utility.
To better assess the at-risk foot and to prevent ulceration, the practitioner should integrate quantitative models of dynamic foot plantar pressures, such as in-shoe and barefoot PPPs, with the regular clinical screening examination. Prospective studies are needed to evaluate causality between other variables of mechanical stress and DFUs. (J Am Podiatr Med Assoc 103(4): 322–332, 2013)
Foot ulcers are among the most serious complications of diabetes and can lead to amputation. Diabetic foot ulcers (DFUs) often fail to heal with standard wound care, thereby making new treatments necessary. This case series describes the addition of a dehydrated amniotic membrane allograft (DAMA) to standard care in unresolved DFUs.
This is a single-center retrospective chart review of eight patients who had one to three applications of DAMA to nine DFUs that had failed to resolve despite offloading, other standard care, and adjuvant therapies. Following initial DAMA placement, wound size (length, width, depth) was measured every 1 to 2 weeks until closure. The principal outcome assessed was mean time to wound closure; other outcomes included mean percent reduction from baseline in wound area and volume at weeks 2 to 8.
All wounds were closed a mean of 9.2 weeks after the first DAMA application (range, 3.0–13.5 weeks). Compared with baseline, wound area and volume, respectively, were reduced by a mean of 48% and 60% at week 2 and by 89% and 91% at week 8. Time to closure was shorter among four patients who had three DAMA applications (mean, 8.3 weeks; range, 4.0–11.0 weeks) than among three patients who had only one application (mean, 12.1 weeks; range, 9.5–13.5 weeks).
Chronic, unresolved DFUs treated with DAMA rapidly improved and reached closure in an average of 9.2 weeks. These cases suggest that DAMA can facilitate closure of DFUs that have failed to respond to standard treatments.
Background: Diabetic foot ulceration is a severe complication of diabetes characterized by chronic inflammation and impaired wound healing. This study aimed to evaluate the effect of a medical device gel based on adelmidrol + trans-traumatic acid in the healing process of diabetic foot ulcers.
Methods: Thirty-seven diabetic patients with foot ulcers of mild/moderate grade were treated with the gel daily for 4 weeks on the affected area. The following parameters were evaluated at baseline and weekly: 1) wound area, measured by drawing a map of the ulcer and then calculated with photo editing software tools, and 2) clinical appearance of the ulcer, assessed by recording the presence/absence of dry/wet necrosis, infection, fibrin, neoepithelium, exudate, redness, and granulation tissue.
Results: Topical treatment led to progressive healing of diabetic foot ulcers with a significant reduction of the wound area and an improvement in the clinical appearance of the ulcers. No treatment-related adverse events were observed.
Conclusions: The results of this open-label study show the potential benefits of adelmidrol + trans-traumatic acid topical administration to promote reepithelialization of diabetic foot ulcers. Further studies are needed to confirm the observed results.
Background: Diabetic foot ulcers (DFUs) are the main cause of hospitalizations and amputations in diabetic patients. Failure of standard foot care is the most important cause of impaired DFU healing. Dakin’s solution (DS) is a promising broad-spectrum bactericidal antiseptic for management of DFUs. Studies investigating the efficacy of using DS on the healing process of DFUs are scarce. Accordingly, this is the first evidence-based, randomized, controlled trial conducted to evaluate the effect of using diluted DS compared with the standard care in the management of infected DFUs.
Methods: A randomized controlled trial was conducted to assess the efficacy of DS in the management of infected DFUs. Patients were distributed randomly to the control group (DFUs irrigated with normal saline) or the intervention group (DFUs irrigated with 0.1% DS). Patients were followed for at least 24 weeks for healing, reinfection, or amputations. In vitro antimicrobial testing on DS was performed, including determination of its minimum inhibitory concentration, minimum bactericidal concentration, minimum biofilm inhibitory concentration, minimum biofilm eradication concentration, and suspension test.
Results: Replacing normal saline irrigation in DFU standard care with 0.1% DS followed by soaking the ulcer with commercial sodium hypochlorite (0.08%) after patient discharge significantly improved ulcer healing (P < .001) and decreased the number of amputations and hospitalizations (P < .001). The endpoint of death from any cause (risk ratio, 0.13; P = .029) and the amputation rate (risk ratio, 0.27; P < .001) were also significantly reduced. The effect on ulcer closure (OR, 11.9; P < .001) was significantly enhanced in comparison with the control group. Moreover, DS irrigation for inpatients significantly decreased bacterial load (P < .001). The highest values for the in-vitro analysis of DS were as follows: minimum inhibitory concentration (MIC), 1.44%; minimum bactericidal concentration (MBC), 1.44%; minimum biofilm inhibitory concentration (MBIC), 2.16%; and minimum biofilm eradication concentration (MBEC), 2.87%.
Conclusions: Compared with standard care, diluted DS (0.1%) was more effective in the management of infected DFUs. Dakin’s solution (0.1%) irrigation with debridement followed by standard care is a promising method in the management of infected DFUs.
Background: Silicone gel sheeting is an effective therapeutic intervention in the management of scar tissue. This pilot study was designed to examine the effect of silicone gel sheeting in preventing reulceration at former wound sites in diabetic patients.
Methods: Thirty patients with diabetes and a healed plantar neuropathic foot ulcer were enrolled and investigated in this randomized controlled trial. Participants with a newly healed ulcer were assigned to use either silicone gel sheeting or emollient cream daily for 3 months.
Results: Compared with emollient cream use, the use of silicone gel sheeting did not diminish and may have potentially increased the risk of reulceration.
Conclusions: Silicone gel sheeting does not seem to reduce the risk of reulceration in diabetic patients. The results of this trial should be viewed with caution given the small sample size. (J Am Podiatr Med Assoc 101(2): 116–123, 2011)
Background: Neurologic screening tests are often used to identify and stratify patients at risk for diabetic foot complications such as infections, ulcers, and amputations. Two of the most commonly cited methods are the 5.07 Semmes-Weinstein monofilament (SWM) for loss of protective sensation and vibratory sensation testing. The aim of this study was to determine whether combined SWM and the timed vibration test (TVT) more effectively predicts diabetic foot ulcer (DFU) development compared with each test alone.
Methods: An electronic medical record database search was performed restricted to podiatric medical clinic patients with diabetes and DFU ICD-10 diagnosis codes. Of 200 patients who met the criteria, 24 developed DFUs. A statistical analysis was performed comparing the SWM and TVT at various cutoff times and the combined SWM/TVT in their ability to predict DFUs.
Results: Statistical analysis revealed that the TVT cutoff time of less than 4 sec was superior to the other times for prediction of DFUs. The combined SWM/TVT results at less than 4 sec were superior to each test individually: sensitivity, 87.5%; specificity, 84.7%; positive predictive value, 43.8%; and receiver operating characteristics area under the curve, 0.86.
Conclusions: The SWM combined with TVT was shown to be superior compared with either test alone in discriminating DFU risk. In addition, the TVT cutoff time of less than 4 sec proved to have greater diagnostic yield than other times, including 0 sec. This unexpected finding might impact providers relying on the absence of vibration sensation via tuning fork testing as an optimal marker of DFU risk.
Integra bilayer wound matrix (IBWM) is a bilayer skin replacement system composed of a dermal regeneration layer and a temporary epidermal layer. It is used to treat various types of deep, large wounds via an inpatient procedure in an operating room. We sought to determine ease of use and effectiveness of IBWM in an outpatient clinical setting when treating diabetic foot ulcers. In addition, no epidermal autografting was performed in conjunction with the IBWM after silicone release, as is common in the inpatient setting.
This 12-week, single-arm, prospective pilot study was conducted in three outpatient clinics. Weekly evaluations included monitoring the wound for signs of infection during the 12-week follow-up phase.
Eleven patients with diabetic foot ulcers who met the inclusion and exclusion criteria were enrolled. One patient was discontinued from the study owing to noncompliance leading to a serious adverse event. Therefore, ten patients who received the study intervention were included in the per-protocol population reported herein. The mean patient age was 60.6 years, with an average 11-year history of diabetes mellitus. Each ulcer was located on the plantar aspect of the foot. No infection was reported during the study. Patients treated with IBWM showed progressive wound healing over time: the greatest mean wound reduction was approximately 95% in week 12. Seven of ten patients (70%) achieved complete wound closure by week 12. No recurrent ulcers were reported during follow-up.
These results are consistent with the hypothesis that IBWM is easy to use, safe, and effective when used on diabetic foot ulcers in an outpatient clinical setting without the secondary procedure of autografting for closure. (J Am Podiatr Med Assoc 103(4): 274–280, 2013)
Background: The removal of necrotic tissue from chronic wounds is required for wound healing to occur. Hydrodebridement (jet lavage) and superoxidized aqueous solution have been independently used for debriding wounds. We sought to investigate the use of superoxidized aqueous solution with a jet lavage system.
Methods: Twenty patients with diabetic foot ulcers were randomly assigned in a 1:1 ratio to receive jet lavage debridement with either superoxidized aqueous solution or standard saline weekly.
Results: There was no significant difference between the two treatments in the reduction of bacterial load or wound size in 4 weeks. No adverse reactions were reported for either treatment.
Conclusions: The use of superoxidized aqueous solution for jet lavage debridement seemed to be as safe and effective as saline. Future investigations should concentrate on whether superoxidized aqueous solution may reduce the bacterial air contamination associated with hydrodebridement. (J Am Podiatr Med Assoc 101(2): 124–126, 2011)
Background: Point-of-care testing for infection might help podiatric physicians optimize management of diabetic foot ulcers (DFUs). Glycologic’s proprietary GLYWD product has been developed to detect changes in a patient’s immunologic/inflammatory response related to wound infection. We evaluated how bacterial presence in DFUs relates to GLYWD test outcome.
Methods: This was a single-organization, prospective, controlled cohort study of clinical opinion versus GLYWD test result for DFU infection status and the appraisal of bacterial presence in the wounds and semiquantitative microbiology swab at weeks 0, 3, 6, 12, and 18. Spearman correlation, backward elimination linear regression, and principal components analysis were applied to determine which variables, including degree of bacterial load, are associated with a positive clinical opinion or GLYWD result for DFU infection.
Results: Forty-eight patients were enrolled, and 142 complete wound appraisals were conducted; a consensus outcome between clinical opinion and GLYWD result was achieved in most (n = 122, 86%). Clinical opinion significantly correlated with a higher bacterial load (Spearman rho = 0.38; P < .01), whereas GLYWD did not (rho = –0.010; P = .91). This observation was corroborated with logistic regression analysis, in which a previous observation of both clinical opinion and GLYWD associating with wound purulence and erythema was also confirmed.
Conclusions: Podiatric physicians are guided by hallmark signs of DFU infection, such as erythema and purulence; furthermore, we found that clinical opinion of infection correlates with increased bacterial load. GLYWD test results match clinical opinion in most cases, although the results obtained with this point-of-care method suggest that the degree of bacterial presence might not necessarily mean a higher chance of inducing an immunologic/inflammatory host response to said bacteria.