Background: It is hypothesized that moisture regulation specific to the area of contact results in local wound conditions more amenable to healing, which would result in faster and more frequent wound closure. TheraGauze is a new polymer-impregnated dressing designed to regulate moisture to a varying degree over the entire surface of a wound.
Methods: This prospective, randomized, multicenter study examined outcomes from treatment of diabetic foot ulcers with TheraGauze and TheraGauze in conjunction with becaplermin. We also compared these outcomes with historical data from the literature that used saline-moistened gauze and becaplermin.
Results: The rates of wound closure with TheraGauze and TheraGauze + becaplermin were 0.37 and 0.41 cm2/week, respectively (P = .34). The difference between these values was not statistically significant. We also observed high closure rates at 12 weeks (46.2% in both groups) and 20 weeks (61.5% with TheraGauze alone and 69.2% with TheraGauze + becaplermin). These data were also compared with historical data for closure rates (0.18 cm2/week) and percentage of wounds closed using saline-moistened gauze alone and becaplermin with saline-moistened gauze (0.24 cm2/week) from a variety of studies.
Conclusions: Wounds in which moisture content was regulated with TheraGauze showed more rapid change in wound area and a higher percentage of wounds achieving closure at 12 and 20 weeks regardless of whether becaplermin was used. (J Am Podiatr Med Assoc 100(3): 155–160, 2010)
Offloading devices for diabetic foot ulcers (DFU) generally restrict exercise. In addition to traditional health benefits, exercise could benefit DFU by increasing blood flow and acting as thermotherapy. This study functionally evaluated a cycling cleat designed for forefoot DFU.
Fifteen individuals at risk of developing a DFU used a recumbent stationary bicycle to complete one 5-minute cycling bout with the DFU cleat on their study foot and one 5-minute bout without it. Foot stress was evaluated by plantar pressure insoles during cycling. Laser Doppler perfusion monitored blood flow to the hallux. Infrared photographs measured foot temperature before and after each cycling bout.
The specialized cleat significantly reduced forefoot plantar pressure (9.9 kPa versus 62.6 kPa, P < .05) and pressure time integral (15.4 versus 76.4 kPa*sec, P < .05). Irrespective of footwear condition, perfusion to the hallux increased (3.97 ± 1.2 versus 6.9 ± 1.4 tissue perfusion units, P < .05) after exercise. Infrared images revealed no changes in foot temperature.
The specialized cleat allowed participants to exercise with minimal forefoot stress. The observed increase in perfusion suggests that healing might improve if patients with active DFU were to use the cleat. Potential thermotherapy for DFU was not supported by this study. Evaluation of the device among individuals with active DFU is now warranted.
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.
Diabetic foot ulcer (DFU) is a serious health problem. Major amputation increases the risk of mortality in patients with DFU; therefore, treatment methods other than major amputation come to the fore for these patients. Graft applications create an appropriate environment for the reproduction of epithelial cells. Similarly, epidermal growth factor (EGF) also stimulates epithelization and increases epidermis formation. In this study, we aimed to compare patients with DFU treated with EGF and those treated with a split-thickness skin graft.
Patients who were treated for DFU in the general surgery clinic were included in the study. The patients were evaluated retrospectively according to their demographic characteristics, wound characteristics, duration of treatment, and treatment modalities.
There were 26 patients in the EGF group and 21 patients in the graft group. The mean duration of treatment was 7 weeks (4-8 weeks) in the EGF group and 5.3 weeks (4-8 weeks) in the graft group (P < .05). In the EGF group, wound healing could not be achieved in one patient during the study period. In the graft group, no recovery was achieved in three patients (14.2%) in the donor site. Graft loss was detected in four patients (19%), and partial graft loss was observed in three patients (14.2%). The DFU of these patients were on the soles (85.7%). These patients have multiple comorbidities.
EGF application may be preferred to avoid graft complications in the graft area and the donor site, especially in elderly patients with multiple comorbidities and wounds on the soles.
This study investigated the resistance of bacteria isolated from diabetic foot ulcers (DFUs) to antibiotics frequently used in the management of the diabetic foot infections, at a range of pH values (pH 6.5, 7.5, and 8.5) known to exist in DFU wound fluid. This study aimed to determine whether changes (or atypical stasis) in wound fluid pH modulate the antibiotic resistance of DFU isolates, with potential implications in relation to the suppression/eradication of bacterial infections in DFUs.
Thirty bacterial isolates were recovered from DFU wound fluid, including Staphylococcus spp, Staphylococcus aureus, Escherichia coli, Streptococcus spp, Pseudomonas spp, and Pseudomonas aeruginosa. The resistances of these isolates to a panel of antibiotics currently used in the treatment of infected or potentially infected DFUs, ie, ciprofloxacin, amoxicillin-clavulanate, doxycycline, and piperacillin-tazobactam, at the previously mentioned pH values were determined by a modification of the Kirby-Bauer assay.
The resistance of DFU isolates to clinically relevant antibiotics was significantly affected by the pH levels in DFU wound fluid.
These findings highlight the importance of a more comprehensive understanding of the conditions in DFUs to inform clinical decision making in the selection and application of antibiotics in treating these difficult-to-heal wounds. The scale of the differences in the efficacies of antibiotics at the different pH values examined is likely to be sufficient to suggest reconsideration of the antibiotics of choice in the treatment of DFU infection.
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)
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)
In the author's clinical experience in rating venous ulcers, human skin equivalent has been efficacious, safe, cost-effective, and easy to use. This innovation is likely to become an important therapeutic tool for podiatric physicians who treat venous ulcers. Leg ulcers are a large economic burden to society, both in direct and total costs, including patient time lost from work for labor- and time-intensive therapies. The cost-containing measures of the managed care environment encourage treatment of venous ulcers in an outpatient center. Because human skin equivalent can be applied in such a setting, podiatric physicians will be able to treat venous ulcers routinely without referring patients to more costly settings such as hospitals or surgical centers. Because human skin equivalent is an effective alternative to standard venous ulcer therapies, this agent, which is currently under review by the Food and Drug Administration, should provide a viable treatment that may reduce the total costs associated with venous ulcer care.
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.