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Biomedical subjects

Lawrence A Lavery

Publications and source records attributed to Lawrence A Lavery.

At least 19 recordsLinked to original sources
PubMed2007

Preventing diabetic foot ulcer recurrence in high-risk patients: use of temperature monitoring as a self-assessment tool.

OBJECTIVE: The purpose of this study was to evaluate the effectiveness of a temperature monitoring instrument to reduce the incidence of foot ulcers in individuals with diabetes who have a high risk for lower extremity complications. RESEARCH DESIGN AND METHODS: In this physician-blinded, randomized, 15-month, multicenter trial, 173 subjects with a previous history of diabetic foot ulceration were assigned to standard therapy, structured foot examination, or enhanced therapy groups. Each group received therapeutic footwear, diabetic foot education, and regular foot care. Subjects in the structured foot examination group performed a structured foot inspection daily and recorded their findings in a logbook. If standard therapy or structured foot examinations identified any foot abnormalities, subjects were instructed to contact the study nurse immediately. Subjects in the enhanced therapy group used an infrared skin thermometer to measure temperatures on six foot sites each day. Temperature differences >4 degrees F (>2.2 degrees C) between left and right corresponding sites triggered patients to contact the study nurse and reduce activity until temperatures normalized. RESULTS: The enhanced therapy group had fewer foot ulcers than the standard therapy and structured foot examination groups (enhanced therapy 8.5 vs. standard therapy 29.3%, P = 0.0046 and enhanced therapy vs. structured foot examination 30.4%, P = 0.0029). Patients in the standard therapy and structured foot examination groups were 4.37 and 4.71 times more likely to develop ulcers than patients in the enhanced therapy group. CONCLUSIONS: Infrared temperature home monitoring, in serving as an "early warning sign," appears to be a simple and useful adjunct in the prevention of diabetic foot ulcerations.

Adult↗
PubMed2006

Validation of a diabetic foot surgery classification.

The purpose of this project was to evaluate associations of increasing diabetic foot surgery stage with postoperative outcome. This project, designed as a retrospective cohort model, was conducted at three large, urban referral-based diabetic foot clinics. The investigators abstracted medical records from 180 patients with diabetes, 76.1% male, aged 57.8 +/- 11.2 years, falling equally into four classes of a previously reported diabetic foot surgery classification system. These classes included class 1 (elective), class 2 (prophylactic), class 3 (curative) and class 4 (emergency). There was a significant trend towards increasing risk of ulceration/reulceration (chi2(trend) = 17.8, P = 0.0001), peri-postoperative infection (chi2(trend) = 96.9, P = 0.0001), all-level amputation (chi2(trend) = 41.7, P = 0.001) and major amputation (chi2(trend) = 8.6, P = 0.003), with increasing class of foot surgery. The results of this study suggest that a non vascular foot surgery classification system including variables such as the presence or absence of neuropathy, an open wound and acute infection may be predictive of peri- and postoperative complications. This may assist the surgeon in better identifying risk when determining a rationale for and type of surgery in persons with diabetes.

Aged↗
PubMed2006

Risk factors for foot infections in individuals with diabetes.

OBJECTIVE: To prospectively determine risk factors for foot infection in a cohort of people with diabetes. RESEARCH DESIGN AND METHODS: We evaluated then followed 1,666 consecutive diabetic patients enrolled in a managed care-based outpatient clinic in a 2-year longitudinal outcomes study. At enrollment, patients underwent a standardized general medical examination and detailed foot assessment and were educated about proper foot care. They were then rescreened at scheduled intervals and also seen promptly if they developed any foot problem. RESULTS: During the evaluation period, 151 (9.1%) patients developed 199 foot infections, all but one involving a wound or penetrating injury. Most patients had infections involving only the soft tissue, but 19.9% had bone culture-proven osteomyelitis. For those who developed a foot infection, compared with those who did not, the risk of hospitalization was 55.7 times greater (95% CI 30.3-102.2; P < 0.001) and the risk of amputation was 154.5 times greater (58.5-468.5; P < 0.001). Foot wounds preceded all but one infection. Significant (P < 0.05) independent risk factors for foot infection from a multivariate analysis included wounds that penetrated to bone (odds ratio 6.7), wounds with a duration >30 days (4.7), recurrent wounds (2.4), wounds with a traumatic etiology (2.4), and presence of peripheral vascular disease (1.9). CONCLUSIONS: Foot infections occur relatively frequently in individuals with diabetes, almost always follow trauma, and dramatically increase the risk of hospitalization and amputation. Efforts to prevent infections should be targeted at people with traumatic foot wounds, especially those that are chronic, deep, recurrent, or associated with peripheral vascular disease.

Adult↗
PubMed2006

Consensus statement on negative pressure wound therapy (V.A.C. Therapy) for the management of diabetic foot wounds.

UNLABELLED: In 2004, a multidisciplinary expert panel convened at the Tucson Expert Consensus Conference (TECC) to determine appropriate use of negative pressure wound therapy as delivered by a Vacuum Assisted Closure device (V.A.C. THERAPY, KCI, San Antonio, Texas) in the treatment of diabetic foot wounds. These guidelines were updated by a second multidisciplinary expert panel at a consensus conference on the use of V.A.C. THERAPY, held in February 2006, in Miami, Florida. This updated version of the guidelines summarizes current clinical evidence, provides practical guidance, offers best practices to clinicians treating diabetic foot wounds, and helps direct future research. The Miami consensus panel discussed the following 12 key questions regarding V.A.C. THERAPY: (1) How long should V.A.C. THERAPY be used in the treatment of a diabetic foot wound? (2) Should V.A.C." THERAPY be applied without debriding the wound? (3) How should the patient using V.A.C. THERAPY be evaluated on an outpatient basis? (4) When should V.A.C. THERAPY be applied following revascularization? (5) When should V.A.C. THERAPY be applied after incision, drainage, and debridement of infection? (6) Should V.A.C. THERAPY be applied over an active soft tissue infection? (7) How should V.A.C. THERAPY be used in patients with osteomyelitis? (8) How should noncompliance to V.A.C. THERAPY be defined? (9) How should V.A.C. THERAPY be used in combination with other modalities? (10) Should small, superficial wounds be considered for V.A.C. THERAPY? (11) How should success in the use of V.A.C. THERAPY be defined? (12) How can one combine effective offloading and V.A.C. THERAPY?

Algorithms↗
PubMed2005

Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial.

BACKGROUND: Diabetic foot wounds, particularly those secondary to amputation, are very complex and difficult to treat. We investigated whether negative pressure wound therapy (NPWT) improves the proportion and rate of wound healing after partial foot amputation in patients with diabetes. METHODS: We enrolled 162 patients into a 16-week, 18-centre, randomised clinical trial in the USA. Inclusion criteria consisted of partial foot amputation wounds up to the transmetatarsal level and evidence of adequate perfusion. Patients who were randomly assigned to NPWT (n=77) received treatment with dressing changes every 48 h. Control patients (n=85) received standard moist wound care according to consensus guidelines. NPWT was delivered through the Vacuum Assisted Closure (VAC) Therapy System. Wounds were treated until healing or completion of the 112-day period of active treatment. Analysis was by intention to treat. This study has been registered with , number NCT00224796. FINDINGS: More patients healed in the NPWT group than in the control group (43 [56%] vs 33 [39%], p=0.040). The rate of wound healing, based on the time to complete closure, was faster in the NPWT group than in controls (p=0.005). The rate of granulation tissue formation, based on the time to 76-100% formation in the wound bed, was faster in the NPWT group than in controls (p=0.002). The frequency and severity of adverse events (of which the most common was wound infection) were similar in both treatment groups. INTERPRETATION: NPWT delivered by the VAC Therapy System seems to be a safe and effective treatment for complex diabetic foot wounds, and could lead to a higher proportion of healed wounds, faster healing rates, and potentially fewer re-amputations than standard care.

Air Pressure↗
PubMed2005

Disease management for the diabetic foot: effectiveness of a diabetic foot prevention program to reduce amputations and hospitalizations.

OBJECTIVE: To demonstrate the effectiveness of a diabetic foot disease management program in a managed care organization. METHODS: We implemented a lower extremity disease management program consisting of screening and treatment protocols for diabetic members in a managed care organization. Screening consisted of evaluation of neuropathy, peripheral vascular disease, deformities, foot pressures, and history of lower extremity pathology. We stratified patients into low and high-risk groups, and implemented preventive or acute care protocols. Utilization was tracked for 28 months and compared to 12 months of historic data prior to implementation of the disease management program. RESULTS: After we implemented the disease management program, the incidence of amputations decreased 47.4% from 12.89 per 1000 diabetics per year to 6.18 (p<0.05). The number of foot-related hospital admissions decreased 37.8% from 22.86 per 1000 members per year to 14.23 (37.8%). The average inpatient length-of-stay (LOS) was reduced 21.7% from 4.75 to 3.72 days (p<0.05). In addition, there was a 69.8% reduction in the number of skilled nursing facility (SNF) admissions per 1000 members per year (Table 1) and a 38.2% reduction in the average SNF LOS from 8.72 to 6.52 days (p<0.05). CONCLUSION: A population-based screening and treatment program for the diabetic foot can dramatically reduce hospitalizations and clinical outcomes.

Adult↗
PubMed2005

Wear and biomechanical characteristics of a novel shear-reducing insole with implications for high-risk persons with diabetes.

OBJECTIVE: This study was designed to measure pressure and shear reduction of a novel insole design. METHODS: We compared three multilayer viscoelastic insoles to a novel insole design (Glide-Soft, Xilas Medical, Inc., San Antonio, TX). The bottom pad of each insole was fabricated from firm-density Plastazote [Apex Foot Products (now Aetrex), South Hackensack, NJ] with an upper of Plastazote, ethyl vinyl acetate, or PORON (Langer Biomechanics Group, Inc., Deer Park, NY). The GlideSoft design used the same materials with two intervening thin sheets of a low friction material. We measured foot pressures, shear, and material stiffness prospectively as the insoles aged during daily usage in 30 healthy adults. We used the F-Scan (Tekscan, Inc., Boston, MA) to determine in-shoe foot pressures and the Automated Stress-relaxation Creep Indenter System (Xilas Medical) to measure material stiffness. To evaluate shear force, the insole was placed on the slide assembly of a custom-designed shear tester equipped with a reciprocating mechanism and force transducers. RESULTS: The GlideSoft exhibited 57% less peak shear force than the standard insole (P < 0.05) in laboratory testing under simulated conditions. Ethyl vinyl acetate had higher compressive stiffness values than Plastazote and PORON at all test intervals (P < 0.05). There were no statistical differences between any of the insoles for peak in-shoe pressure measurements (P > 0.05). CONCLUSIONS: The GlideSoft design demonstrated a significant reduction in shear while maintaining equivalent pressure reduction compared with standard insole designs with three different material combinations for up to 320,000 steps.

Diabetic Foot↗
PubMed2005

Evaluation of removable and irremovable cast walkers in the healing of diabetic foot wounds: a randomized controlled trial.

OBJECTIVE: The purpose of this study was to evaluate the effectiveness of a removable cast walker (RCW) and an "instant" total contact cast (iTCC) in healing neuropathic diabetic foot ulcerations. RESEARCH DESIGN AND METHODS: We randomly assigned 50 patients with University of Texas grade 1A diabetic foot ulcerations into one of two off-loading treatment groups: an RCW or the same RCW wrapped with a cohesive bandage (iTCC) so patients could not easily remove the device. Subjects were evaluated weekly for 12 weeks or until wound healing. RESULTS: An intent-to-treat analysis showed that a higher proportion of patients had ulcers that were healed at 12 weeks in the iTCC group than in the RCW group (82.6 vs. 51.9%, P = 0.02, odds ratio 1.8 [95% CI 1.1-2.9]). Of the patients with ulcers that healed, those treated with an iTCC healed significantly sooner (41.6 +/- 18.7 vs. 58.0 +/- 15.2 days, P = 0.02). CONCLUSIONS: Modification of a standard RCW to increase patient adherence to pressure off-loading may increase both the proportion of ulcers that heal and the rate of healing of diabetic neuropathic wounds.

Casts, Surgical↗
PubMed2004

It's not what you put on, but what you take off: techniques for debriding and off-loading the diabetic foot wound.

The basic etiology of neuropathic diabetic foot wounds involves pressure in conjunction with cycles of repetitive stress, leading to failure of skin and soft tissue. The central tenet of any treatment plan addressing neuropathic diabetic foot wounds is the appropriate debridement of nonviable tissue coupled with adequate pressure relief (off-loading). Although numerous advances have been made in the treatment of diabetic foot wounds, including bioengineered tissues, autologous and exogenous cytokine delivery systems, and potentially effective topical antimicrobial modalities, none will succeed without addressing effective debridement and off-loading. Specific debridement and off-loading techniques are discussed, along with available supporting evidence. This includes the use of the "instant" total contact cast, among other modalities.

Debridement↗
PubMed2004

Decreasing foot pressures while implementing topical negative pressure (vacuum-assisted closure) therapy.

Over the past generation, there have been a number of significant advances in wound healing in general. Unfortunately, much of this has not translated into increased success in healing wounds on the sole of the foot. We believe that much of this therapeutic disconnect has to do with an inadequate merging of pressure off-loading technologies and active wound-healing technologies. This article discusses such a merger between removable cast walkers and topical negative pressure (also known as vacuum-assisted closure).

Journal Article↗
PubMed2004

Home monitoring of foot skin temperatures to prevent ulceration.

OBJECTIVE: To evaluate the effectiveness of at-home infrared temperature monitoring as a preventative tool in individuals at high risk for diabetes-related lower-extremity ulceration and amputation. RESEARCH DESIGN AND METHODS: Eighty-five patients who fit diabetic foot risk category 2 or 3 (neuropathy and foot deformity or previous history of ulceration or partial foot amputation) were randomized into a standard therapy group (n = 41) or an enhanced therapy group (n = 44). Standard therapy consisted of therapeutic footwear, diabetic foot education, and regular foot evaluation by a podiatrist. Enhanced therapy included the addition of a handheld infrared skin thermometer to measure temperatures on the sole of the foot in the morning and evening. Elevated temperatures (>4 degrees F compared with the opposite foot) were considered to be "at risk" of ulceration due to inflammation at the site of measurement. When foot temperatures were elevated, subjects were instructed to reduce their activity and contact the study nurse. Study subjects were followed for 6 months. RESULTS: The enhanced therapy group had significantly fewer diabetic foot complications (enhanced therapy group 2% vs. standard therapy group 20%, P = 0.01, odds ratio 10.3, 95% CI 1.2-85.3). There were seven ulcers and two Charcot fractures among standard therapy patients and one ulcer in the enhanced therapy group. CONCLUSIONS: These results suggest that at-home patient self-monitoring with daily foot temperatures may be an effective adjunctive tool to prevent foot complications in individuals at high risk for lower-extremity ulceration and amputation.

Diabetes Complications↗
PubMed2004

Variability in activity may precede diabetic foot ulceration.

OBJECTIVE: To evaluate the role of activity in the development of neuropathic foot ulceration in individuals with diabetes. RESEARCH DESIGN AND METHODS: We evaluated the first 100 consecutive individuals with diabetes (95.0% male, aged 68.5 +/- 10.0 years with concomitant neuropathy, deformity, and/or a history of lower-extremity ulceration/partial foot amputation) enrolled in an ongoing prospective longitudinal activity study. Subjects used a high-capacity continuous computerized activity monitor. Data were collected continuously over a minimum of 25 weeks (or until ulceration) with daily activity units expressed as means +/- SD. RESULTS: Eight subjects ulcerated during the evaluation period of 37.1 +/- 12.3 weeks. The average daily activity was significantly lower in individuals who ulcerated compared with individuals who did not ulcerate (809.0 +/- 612.2 vs. 1,394.5 +/- 868.5, P = 0.03). Furthermore, there was a large difference in variability between groups. The coefficient of variation was significantly greater in the ulceration group compared with the no ulceration group (96.4 +/- 50.3 vs. 44.7 +/- 15.4%, P = 0.0001). In the 2 weeks preceding the ulcerative event, the coefficient of variation increased even further (115.4 +/- 43.0%, P = 0.02), but there was no significant difference in average daily activity during that period (P = 0.5). CONCLUSIONS: The results of this study suggest that individuals with diabetes who develop ulceration may actually have a lower overall activity than their counterparts with no ulceration, but the quality of that activity may be more variable. Perhaps modulating the "peaks and valleys" of activity in this population through some form of feedback might prove to reduce risk for ulceration in this very-high-risk population.

Activities of Daily Living↗
PubMed2004

Guidelines regarding negative wound therapy (NPWT) in the diabetic foot.

The purpose of these guidelines is to the summarize consensus of a multidisciplinary expert advisory panel convened to determine appropriate use of negative pressure wound therapy (NPWT), also known as Vacuum-Assisted Closure or V.A.C. Therapy, in the treatment of diabetic foot wounds. The Tucson Expert Consensus Conference (TECC) on V.A.C. Therapy was convened in an effort to guide the direction for future research either to confirm or refute current consensus while providing practical guidance to the clinician currently treating diabetic foot wounds. The consensus committee discussed and commented on the following ten key questions regarding NPWT: 1) How long should NPWT be used in the treatment of a diabetic foot wound? 2) Should NPWT be applied to a wound that has not been debrided? 3) How should the patient using NPWT be evaluated on an outpatient basis? 4) When should NPWT be applied following lower-extremity bypass? 5) When should NPWT be applied after incision and drainage of infection? 6) How should NPWT be used in patients with osteomyelitis? 7) How should nonadherence (i.e., noncompliance) be defined in the patient on NPWT? When should NPWT be discontinued in this population? 8) How should NPWT be used in combination with other modalities? 9) Should small, superficial, noninfected wounds be considered for NPWT? 10) How should we define success in future studies of NPWT?

Contraindications↗
PubMed2003

Clinical efficacy of the first metatarsophalangeal joint arthroplasty as a curative procedure for hallux interphalangeal joint wounds in patients with diabetes.

OBJECTIVE: To evaluate the safety and efficacy of first metatarsophalangeal joint arthroplasty compared with standard, nonsurgical management of wounds at the plantar hallux interphalangeal joint in patients with diabetes. RESEARCH DESIGN AND METHODS: We evaluated 41 patients with ulcers classified as University of Texas Grade 1A or 2A at the plantar aspect of the hallux interphalangeal joint using a case-control model [correction]. Case subjects were patients treated with resectional arthroplasty and control subjects received standard nonsurgical care. Both groups received standard off-loading and wound care. Outcomes included time to healing, reulceration, infection, and amputation. RESULTS: The surgery group healed significantly faster than patients in the standard therapy group (standard 67.1 +/- 17.1 versus surgery 24.2 +/- 9.9 days, P = 0.0001), and they had fewer recurrent ulcers (standard 35.0 versus surgery 4.8%, P = 0.02, odds ratio 7.6, 95% CI 1.1-261.7) Both groups had similar rates of infection (standard 38.1 versus surgery 40.0%, P = 0.9) and amputation (standard 10.0 versus surgery 4.8%, P = 0.5). CONCLUSIONS: Results suggest that resectional arthroplasty is a safe and effective procedure to treat wounds of the plantar hallux compared with nonsurgical therapy.

Age of Onset↗
PubMed2003

Predictive value of foot pressure assessment as part of a population-based diabetes disease management program.

OBJECTIVE: To evaluate the effectiveness of dynamic plantar pressure assessment to determine patients at high risk for neuropathic ulceration. In choosing the cut point, we looked for an optimum combination of sensitivity and specificity of plantar pressure to screen for neuropathic ulceration. RESEARCH DESIGN AND METHODS: A total of 1,666 consecutive individuals with diabetes (50.3% male) presenting to a large urban managed care-based outpatient clinic were enrolled in this longitudinal 2-year outcome study. Patients received a standardized medical and musculoskeletal assessment at the time of enrollment, including evaluation in an onsite gait laboratory. RESULTS: Of the entire population, 263 patients (15.8%) either presented with or developed an ulcer during the 24-month follow-up period. As expected, baseline peak plantar pressure was significantly higher in the ulcerated group than in the group who did not ulcerate (95.5 +/- 26.4 vs. 85.1 +/- 27.3 N/cm(2), P < 0.001). There was also a trend toward increased pressure with increasing numbers of foot deformities, as well as with increasing foot risk classification (P = 0.0001). Peak pressure was not a suitable diagnostic tool by itself to identify high-risk patients. After eliminating patients without loss of protective sensation, using receiver operating characteristic (ROC) analysis, the optimal cut point, as determined by a balance of sensitivity and specificity, was 87.5 N/cm(2), yielding a sensitivity of 63.5% and a specificity of 46.3%. CONCLUSIONS: The data from this evaluation continue to support the notion that elevated foot pressure is an important risk factor for foot complications. However, the ROC analysis suggests that foot pressure is a poor tool by itself to predict foot ulcers.

Aged↗
PubMed2003

Diabetic foot syndrome: evaluating the prevalence and incidence of foot pathology in Mexican Americans and non-Hispanic whites from a diabetes disease management cohort.

OBJECTIVE: To report the incidence of diabetes-related lower-extremity complications in a cohort of patients enrolled in a diabetes disease management program. RESEARCH DESIGN AND METHODS: We evaluated screening results and clinical outcomes for the first 1,666 patients enrolled in a disease management program for a period of 24 months (50.3% men, aged 69.1 +/- 11.1 years). RESULTS: The incidence of ulceration, infection, amputation, and lower-extremity bypass was 68.4, 36.5, 5.9, and 7.7 per 1,000 persons with diabetes per year. Amputation incidence was higher in Mexican Americans than in non-Hispanic whites (7.4/1,000 vs. 4.1/1,000; P = 0.003, odds ratio [OR] 1.8, 95% CI 1.2-2.7). The amputation-to-ulcer ratio was 8.7%. The incidence of Charcot arthropathy was 8.5/1,000 per year. Charcot was more common in non-Hispanic whites than in Mexican Americans (11.7/1,000 vs. 6.4/1,000; P = 0.0001, 1.8, 1.3-2.5). The prevalence of peripheral vascular disease was 13.5%, with no significant difference based on ethnicity (P = 0.3). There was not a significant difference in incidence of foot infection (P = 0.9), lower-extremity bypass (P = 0.3), or ulceration (P = 0.1) based on ethnicity. However, there were more failed bypasses in Mexican Americans (33%) than in non-Hispanic whites (7.1%). Mexican Americans were 3.8 times more likely to have a failed bypass (leading to an amputation) or be diagnosed as "nonbypassable" than non-Hispanic whites (75.0 vs. 44.0%; P = 0.01, 3.8, 1.2-11.8). CONCLUSIONS: The incidence of amputation is higher in Mexican Americans, despite rates of ulceration, infection, vascular disease, and lower-extremity bypass similar to those of non-Hispanic whites. There may be factors associated with failed or failure to bypass that mandate further investigation.

Age of Onset↗
PubMed2003

Activity patterns of patients with diabetic foot ulceration: patients with active ulceration may not adhere to a standard pressure off-loading regimen.

OBJECTIVE: To evaluate the activity of patients with diabetic foot ulcerations and their adherence to their pressure off-loading device. RESEARCH DESIGN AND METHODS: We enrolled 20 subjects treated for neuropathic diabetic foot wounds corresponding to University of Texas grade 1 stage A. All were off-loaded using a removable cast walker (RCW). We recorded the total activity (measured in activity steps per day) taken on a waist-worn computerized accelerometer. We subsequently correlated this to activity recorded on an RCW-mounted accelerometer, which was not readily accessible to the patient. RESULTS: There were a mean 1219.1 +/- 821.2 activity units (steps) taken per patient per day. Patients logged significantly more daily activity units with the protective RCW off than with it on (873.7 +/- 828.0 vs. 345.3 +/- 219.1, P = 0.01). This amounts to only 28% of total daily activity recorded while patients were wearing their RCW. Although a total of 30% of the patients in the study recorded more daily activity units while wearing the device, this subset most adherent to their off-loading regimen still only wore the device for a total of 60% of their total daily activity. CONCLUSIONS: Subjects with diabetic foot ulcerations appear to wear their off-loading devices for only a minority of steps taken each day. This may partially explain the poor results reported from many trials of agents designed to help speed the healing of these wounds. Control of this important aspect of care with less easily removable devices may increase the prevalence of healing.

Age of Onset↗