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.
Benjamin A. Lipsky, Anthony R. Berendt, Paul B. Cornia, James C. Pile, Edgar J. G. Peters, David G. Armstrong, H. Gunner Deery, John M. Embil, Warren S. Joseph, Adolf W. Karchmer, Michael S. Pinzur, and Eric Senneville
Foot infections are a common and serious problem in persons with diabetes. Diabetic foot infections (DFIs) typically begin in a wound, most often a neuropathic ulceration. While all wounds are colonized with microorganisms, the presence of infection is defined by ≥2 classic findings of inflammation or purulence. Infections are then classified into mild (superficial and limited in size and depth), moderate (deeper or more extensive), or severe (accompanied by systemic signs or metabolic perturbations). This classification system, along with a vascular assessment, helps determine which patients should be hospitalized, which may require special imaging procedures or surgical interventions, and which will require amputation. Most DFIs are polymicrobial, with aerobic gram-positive cocci (GPC), and especially staphylococci, the most common causative organisms. Aerobic gram-negative bacilli are frequently copathogens in infections that are chronic or follow antibiotic treatment, and obligate anaerobes may be copathogens in ischemic or necrotic wounds.
Wounds without evidence of soft tissue or bone infection do not require antibiotic therapy. For infected wounds, obtain a post-debridement specimen (preferably of tissue) for aerobic and anaerobic culture. Empiric antibiotic therapy can be narrowly targeted at GPC in many acutely infected patients, but those at risk for infection with antibiotic-resistant organisms or with chronic, previously treated, or severe infections usually require broader spectrum regimens. Imaging is helpful in most DFIs; plain radiographs may be sufficient, but magnetic resonance imaging is far more sensitive and specific. Osteomyelitis occurs in many diabetic patients with a foot wound and can be difficult to diagnose (optimally defined by bone culture and histology) and treat (often requiring surgical debridement or resection, and/or prolonged antibiotic therapy). Most DFIs require some surgical intervention, ranging from minor (debridement) to major (resection, amputation). Wounds must also be properly dressed and off-loaded of pressure, and patients need regular follow-up. An ischemic foot may require revascularization, and some nonresponding patients may benefit from selected adjunctive measures. Employing multidisciplinary foot teams improves outcomes. Clinicians and healthcare organizations should attempt to monitor, and thereby improve, their outcomes and processes in caring for DFIs.
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: 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.
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)
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.
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.
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.
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)
Diabetic foot care management is directed at patients with a history of complications, especially those with rising levels of hemoglobin A1c, and those who have had diabetes for several years. The aim of this study was to cross-culturally adapt a French-language version of the Diabetic Foot Self-care Questionnaire of the University of Malaga (DFSQ-UMA) for use in France.
Cross-cultural adaptation was performed according to relevant international guidelines (International Society for Pharmacoeconomics and Outcomes Research), and the factor structure was determined. Internal consistency was measured using the Cronbach α. Item-total and inter-item correlations were assessed.
The French data set comprised 146 patients. The mean ± SD patient age was 62.60 ± 15.47 years. There were 47 women and 99 men. The structure matrix (with three factors) was tested by confirmatory factor analysis. The 16-item questionnaire had a Cronbach α of 0.92. The mean value for inter-item correlations was 0.48 (range, 0.17–0.86). The rotated solution revealed a three-factor structure that accounted for 48.10% of the variance observed. A significant inverse correlation was observed between questionnaire scores and hemoglobin A1c levels (r = –0.17; P < .01).
This study validates the French-language version of the DFSQ-UMA, which can be used as a self-reported outcome measure for French-speaking patients in France.
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)
We conducted a post-hoc retrospective analysis of patients enrolled in a randomized controlled trial to evaluate overall costs of negative pressure wound therapy (NPWT; V.A.C. Therapy; KCI USA, Inc, San Antonio, Texas) versus advanced moist wound therapy (AMWT) in treating grade 2 and 3 diabetic foot wounds during a 12-week therapy course.
Data from two study arms (NPWT [n = 169] or AMWT [n = 166]) originating from Protocol VAC2001-08 were collected from patient records and used as the basis of the calculations performed in our cost analysis.
A total of 324 patient records (NPWT = 162; AMWT = 162) were analyzed. There was a median wound area reduction of 85.0% from baseline in patients treated with NPWT compared to a 61.8% reduction in those treated with AMWT. The total cost for all patients, regardless of closure, was $1,941,472.07 in the NPWT group compared to $2,196,315.86 in the AMWT group. In patients who achieved complete wound closure, the mean cost per patient in the NPWT group was $10,172 compared to $9,505 in the AMWT group; the median cost per 1 cm2 of closure was $1,227 with NPWT and $1,695 with AMWT. In patients who did not achieve complete wound closure, the mean total wound care cost per patient in the NPWT group was $13,262, compared to $15,069 in the AMWT group. The median cost to close 1 cm2 in wounds that didn't heal using NPWT was $1,633, compared to $2,927 with AMWT.
Our results show greater cost effectiveness with NPWT versus AMWT in recalcitrant wounds that didn't close during a 12-week period, due to lower expenditures on procedures and use of health-care resources.