Search Results
Background: In diabetic patients with complications from peripheral neuropathy, the hyperpressure areas can rapidly lead to ulcerative lesions in the absence of protective sensation. Partial digital silicone orthoses could provide an innovative and functional therapeutic solution in the management of preulcerative areas of the forefoot in neuropathic diabetic patients. We clinically tested this hypothesis.
Methods: Digital off-loading silicone padding was prepared for 89 neuropathic patients with deformities and localized hyperkeratosis in the forefoot. After 3 months and in basal conditions, the number of areas of hyperkeratosis was evaluated together with the hardness of the skin, the number of active lesions, and any adverse events associated with use of the orthosis. The patients were compared to a control group of 78 randomized patients undergoing standard therapy. In a subgroup of 10 patients, a static and dynamic biomechanical evaluation was also conducted with a computerized podobarometric platform.
Results: Both the number of lesions and the prevalence of hyperkeratosis and skin hardness were significantly lower (P < .01) in the group treated with the silicone orthoses than in the control group. No adverse events were reported during the 3 months of observation. The podobarometric analysis highlighted a significant (P < .001) reduction of peak pressure in the areas undergoing orthotic correction.
Conclusions: Silicone padding is effective and safe in the prevention of lesions in neuropathic patients at high risk of ulceration and significantly reduces the incidence of new lesions in the 3-month follow-up period compared to standard treatment. (J Am Podiatr Med Assoc 99(1): 28–34, 2009)
An Assessment of Intralesional Epidermal Growth Factor for Treating Diabetic Foot Wounds
The First Experiences in Turkey
Background:
Intralesional epidermal growth factor (EGF) has been available as a medication in Turkey since 2012. We present the results of our experience using intralesional EGF in Turkey for patients with diabetic foot wounds.
Methods:
A total of 174 patients from 25 Turkish medical centers were evaluated for this retrospective study. We recorded the data on enrolled individuals on custom-designed patient follow-up forms. Patients received intralesional injections of 75 μg of EGF three times per week and were monitored daily for adverse reactions to treatment. Patients were followed up for varying periods after termination of EGF treatments.
Results:
Median treatment duration was 4 weeks, and median frequency of EGF administration was 12 doses. Complete response (granulation tissue >75% or wound closure) was observed in 116 patients (66.7%). Wounds closed with only EGF administration in 81 patients (46.6%) and in conjunction with various surgical interventions after EGF administration in 65 patients (37.3%). Overall, 146 of the wounds (83.9%) were closed at the end of therapy. Five patients (2.9%) required major amputation. Adverse effects were reported in 97 patients (55.7%).
Conclusions:
In patients with diabetic foot ulcer who received standard care, additional intralesional EGF application after infection control provided high healing rates with low amputation rates.
Background:
Below-the-knee amputation (BKA) can be a detrimental outcome of diabetic foot osteomyelitis (DFO). Ideal treatment of DFO is controversial, but studies suggest minor amputation reduces the risk of BKA. We evaluated risk factors for BKA after minor amputation for DFO.
Methods:
This is a retrospective cohort of patients discharged from Denver Health Medical Center from February 1, 2012, through December 31, 2014. Patients who underwent minor amputation for diagnosis of DFO were eligible for inclusion. The outcome evaluated was BKA in the 6 months after minor amputation.
Results:
Of 153 episodes with DFO that met the study criteria, 11 (7%) had BKA. Failure to heal surgical incision at 3 months (P < .001) and transmetatarsal amputation (P = .009) were associated with BKA in the 6 months after minor amputation. Peripheral vascular disease was associated with failure to heal but not with BKA (P = .009). Severe infection, bacteremia, hemoglobin A1c, and positive histopathologic margins of bone and soft tissue were not associated with BKA. The median antibiotic duration was 42 days for positive histopathologic bone resection margin (interquartile range, 32–47 days) and 16 days for negative margin (interquartile range, 8–29 days). Longer duration of antibiotics was not associated with lower risk of BKA.
Conclusions:
Patients who fail to heal amputation sites in 3 months or who have transmetatarsal amputation are at increased risk for BKA. Future studies should evaluate the impact of aggressive wound care or whether failure to heal is a marker of another variable.
Background:
Although total-contact cast (TCC) systems are considered the gold standard for off-loading plantar ulcers, less than 6% of patients with diabetic foot ulcers receive them due to negative perceptions of special technique requirements and time investment in their application and removal. We compared the ease of use and casting time of four TCC systems.
Methods:
Four novice casters applied each of the four TCC systems three times using the manufacturer's written instructions for cast application and removal of each cast type. For each TCC system, casters also provided ratings of quality and effectiveness, their level of confidence in applying each system, and overall ease of use.
Results:
The time to complete the first application of each cast type was not different among TCC systems. However, by the third application, TCC-EZ had a significantly faster application time than the other three TCC systems. In addition, TCC-EZ was considered better overall in packaging and instructions, quality of cast components, and casting method than the other TCC systems. Half of the casters rated TCC-EZ and MedE-Kast as the easiest to apply after the third and final trial, and TCC-EZ and MedE-Kast were rated as being the cast chosen to use in the casters' clinical practices.
Conclusions:
One of the obstacles to use of TCC systems, despite being recognized as the gold standard of off-loading, is the perception of a prolonged learning curve on application. This study demonstrated that TCC-EZ can be applied by novice casters in less than 14 minutes after their third application experience.
Background: The selection of materials for the production of multilayer insoles for diabetic feet is a difficult task owing to the lack of technical information about these materials. Therefore, objective criteria were established for the selection of these materials.
Methods: Mechanical- and comfort-related tests for the mechanical characterization of different materials and their combinations were considered. These tests were conducted according to standardized test methods for polymeric cellular materials.
Results: Criteria for the use of cellular materials were obtained. The properties of accommodation, cushioning, and filling materials were established and the most adequate polymer nature for each of the three applications was identified. Variables that affect the properties of these material combinations were studied.
Conclusions: These test results will allow podiatrists to select insoles in a more objective way, thus achieving a more successful treatment for diabetic foot-related injuries. (J Am Podiatr Med Assoc 98(3): 229–238, 2008)
Background
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.
Methods
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.
Results
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.
Conclusions
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.
Is TCC-EZ a Suitable Alternative to Gold Standard Total-Contact Casting?
A Plantar Pressure Analysis
Background
The total-contact cast (TCC) is the gold standard for off-loading diabetic foot ulcers (DFUs) given its nonremovable nature. However, this modality remains underused in clinical settings due to the time and experience required for appropriate application. The TCC-EZ is an alternative off-loading modality marketed as being nonremovable and having faster and easier application. This study aims to investigate the potential of the TCC-EZ to reduce foot plantar pressures.
Methods
Twelve healthy participants (six males, six females) were fitted with a removable cast walker, TCC, TCC-EZ, and TCC-EZ with accompanying brace removed. These off-loading modalities were tested against a control. Pedar-X technology measured peak plantar pressures in each condition. Statistical analysis of four regions of the foot (rearfoot, midfoot, forefoot, and hallux) was conducted with Friedman and Wilcoxon signed rank tests. Significance was set at P < .05.
Results
All of the off-loading conditions significantly reduced pressure compared with the control, except the TCC-EZ without the brace in the hallux region. There was no statistically significant difference between TCC-EZ and TCC peak pressure in any foot region. The TCC-EZ without the brace obtained significantly higher peak pressures than with the brace. The removable cast walker produced similar peak pressure reduction in the midfoot and forefoot but significantly higher peak pressures in the rearfoot and hallux.
Conclusions
The TCC-EZ is a viable alternative to the TCC. However, removal of the TCC-EZ brace results in minimal plantar pressure reduction, which might limit clinical applications of the TCC-EZ.
Background
Toe amputation is the most common partial foot amputation. Controversy exists regarding whether to primarily close toe amputations or to leave them open for secondary healing. The purpose of this study was to evaluate the results of closed toe amputations in diabetic patients, with respect to wound healing, complications, and the need for further higher level amputation.
Methods
We retrospectively reviewed the results of 40 elective or semi-elective toe amputations with primary closure performed in 35 patients treated in a specialized diabetic foot unit. Patients with abscesses or necrotizing fasciitis were treated emergently and were excluded. Patients in whom clean margins could not be achieved due to extensive cellulitis or tenosynovitis and patients requiring vascular intervention were excluded as well. Outcome endpoints included wound healing at 3 weeks, delayed wound healing, or subsequent higher level amputation.
Results
Out of 40 amputations, 38 healed well. Thirty amputations healed by the time of stitch removal at 3 weeks and eight had delayed healing. In two patients the wounds did not heal and subsequent higher level amputation was eventually required.
Conclusions
In carefully selected diabetic foot patients, primary closure of toe amputations is a safe surgical option. We do not recommend primary closure when infection control is not achieved or in patients requiring vascular reconstruction. Careful patient selection, skillful assessment of debridement margins and meticulous technique are required and may be offered by experienced designated surgeons in a specialized diabetic foot unit.
The Achilles tendon of the patient with Charcot’s foot neuroarthropathy has significantly altered physical properties compared with a normal tendon. Twenty-nine Achilles tendons from patients with Charcot’s foot (n = 20) and non-Charcot’s foot controls (n = 9) were loaded onto a biomechanical testing instrument. The biomechanical properties of the Charcot and control tendons were determined and the tendons were evaluated for differences in ultimate tensile strength and elasticity (Young’s modulus). Biomechanical test data show that there is a significant difference in ultimate tensile strength and elasticity between tendons of patients with Charcot’s foot and those of non-Charcot’s controls. The term diabetic tendo Achillis equinus is introduced as a new finding in diabetic neuroarthropathy. (J Am Podiatr Med Assoc 95(3): 242–246, 2005)
Background
We sought to assess the biomechanical characteristics of the feet of patients with Charcot neuro-osteoarthropathy and to determine reulceration rates before and after personalized conservative orthotic treatment.
Methods
A longitudinal prospective study was performed in 35 patients with Charcot's foot. Although some patients had a history of ulcers, at the study outset no patient had ulcers. All of the patients underwent biomechanical testing and a radiographic study. A radiophotopodogram was prepared by superimposing an imprint of the sole on a plantar radiograph. Based on the results of these tests, an orthopedic insole was prepared and therapeutic footwear prescribed for each foot. The following variables were compared between the Charcot and unaffected feet: previous ulcers and ulcer sites, reulcerations produced after treatment, type of foot (neuropathic/neuroischemic), ankle mobility, first-ray mobility, and relaxed calcaneal stance position. Treatment efficacy was determined by comparing ulcers presenting in patients in the year leading up to the study period and the year in which treatment was received.
Results
In a 1-year period, 70 feet received orthotic treatment, of which 41 were Charcot's feet. Ulceration rates before the study were 73.2% in feet with Charcot's and 31.0% in those without. After 1 year of wearing the customized orthoses, rates fell significantly to 9.8% in the Charcot feet and 0% in the feet without this condition.
Conclusions
Conservative customized orthotic treatment was effective at preventing ulcers and the complications that often lead these patients to surgery.
