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Biomedical subjects

Andrew J M Boulton

Publications and source records attributed to Andrew J M Boulton.

At least 19 recordsLinked to original sources
PubMed2007

The neuropathic diabetic foot.

Diabetic foot problems are common throughout the world, and result in major medical, social and economic consequences for the patients, their families, and society. Foot ulcers are likely to be of neuropathic origin and, therefore, are eminently preventable. Individuals with the greatest risk of ulceration can easily be identified by careful clinical examination of their feet: education and frequent follow-up is indicated for these patients. When infection complicates a foot ulcer, the combination can be limb-threatening, or life-threatening. Infection is defined clinically, but wound cultures assist in identification of causative pathogens. Tissue specimens are strongly preferred to wound swabs for wound cultures. Antimicrobial therapy should be guided by culture results, and although such therapy may cure the infection, it does not heal the wound. Alleviation of the mechanical load on ulcers (offloading) should always be a part of treatment. Plantar neuropathic ulcers typically heal in 6 weeks with nonremovable casts, because pressure at the ulcer site is mitigated and compliance is enforced. The success of other approaches to offloading similarly depends on the patient's adherence to the strategy used for pressure relief.

Algorithms↗
PubMed2007

Does treatment with duloxetine for neuropathic pain impact glycemic control?

OBJECTIVE: We examined changes in metabolic parameters in clinical trials of duloxetine for diabetic peripheral neuropathic pain (DPNP). RESEARCH DESIGN AND METHODS: Data were pooled from three similarly designed clinical trials. Adults with diabetes and DPNP (n = 1,024) were randomized to 60 mg duloxetine q.d., 60 mg b.i.d., or placebo for 12 weeks. Subjects (n = 867) were re-randomized to 60 mg duloxetine b.i.d. or routine care for an additional 52 weeks. Mean changes in plasma glucose, lipids, and weight were evaluated. Regression and subgroup analyses were used to identify relationships between metabolic measures and demographic, clinical, and electrophysiological parameters. RESULTS: Duloxetine treatment resulted in modest increases in fasting plasma glucose in short- and long-term studies (0.50 and 0.67 mmol/l, respectively). A1C did not increase in placebo-controlled studies; however, a greater increase was seen relative to routine care in long-term studies (0.52 vs. 0.19%). Short-term duloxetine treatment resulted in mean weight loss (-1.03 kg; P < 0.001 vs. placebo), whereas slight, nonsignificant weight gain was seen in both duloxetine and routine care groups with longer treatment. Between-group differences were seen for some lipid parameters, but these changes were generally small. Metabolic changes did not appear to impact improvement in pain severity seen with duloxetine, and nerve conduction was also not significantly impacted by treatment. CONCLUSIONS: Duloxetine treatment was associated with modest changes in glycemia in patients with DPNP. Other metabolic changes were limited and of uncertain significance. These changes did not impact the significant improvement in pain observed with duloxetine treatment.

Adult↗
PubMed2006

Evidence-based protocol for diabetic foot ulcers.

BACKGROUND: Diabetic foot ulcers are the single biggest risk factor for nontraumatic foot amputations in persons with diabetes. Foot ulcers occur in 12 to 25 percent of persons with diabetes and precede 84 percent of all nontraumatic amputations in this growing population. Because of the high incidence of foot ulcers, amputations remain a source of morbidity and mortality in persons with diabetes. Strict adherence to evidence-based protocols as described herein will prevent the majority of these amputations. METHODS: The collective experience of treating patients with neuropathic diabetic foot ulcers in four major diabetic foot programs in the United States and Europe was analyzed. RESULTS: The following protocol was developed for patients with diabetic foot ulcers: (1) establishment of good communication among the patient, the wound healing team, and the primary medical doctor; (2) comprehensive, protocol-driven care of the entire patient, including hemoglobin A1c, microalbuminuria, and cholesterol as well as early treatment of retinopathy, nephropathy, and cardiac disease; (3) weekly objective measurement of the wound with digital photography, planimetry, and documentation of the wound-healing process using the Wound Electronic Medical Record, if available; (4) objective evaluation of blood flow in the lower extremities (e.g., noninvasive flow studies); (5) débridement of hyperkeratotic, infected, and nonviable tissue; (6) use of systemic antibiotics for deep infection, drainage, and cellulitis; (7) off-loading; (8) maintenance of a moist wound bed; (9) use of growth factor and/or cellular therapy if the wound is not healing after 3 weeks with this protocol; and (10) consideration of the use of vacuum-assisted therapy in complex wounds. CONCLUSIONS: In diabetic foot ulcers, availability of the above modalities, in combination with early recognition and comprehensive treatment, ensures rapid healing, minimizes morbidity and mortality rates, and eliminates toe and limb amputations in the absence of ischemia and osteomyelitis.

Anti-Bacterial Agents↗
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

Charcot neuroarthropathy: an unusual case and a review of the literature.

Charcot neuroarthropathy is a devastating consequence of diabetes, requiring early identification and immediate management. A differentiation should be made from osteomyelitis and other pathologies. The authors describe a case of Charcot foot with radiological findings of complete fragmentation of the calcaneum. Further investigation with magnetic resonance and white cell-labeled imaging revealed osteomyelitis. Below-knee amputation was the only therapeutic option in this hindfoot collapse complicated with osteomyelitis.

Adult↗
PubMed2006

Patient Interpretation of Neuropathy (PIN) questionnaire: an instrument for assessment of cognitive and emotional factors associated with foot self-care.

OBJECTIVE: Using the common-sense model of illness behavior, we developed and validated a self-report instrument for assessment of patients' cognitive and emotional representations of diabetic peripheral neuropathy (DPN) influencing foot self-care. RESEARCH DESIGN AND METHODS: The Patient Interpretation of Neuropathy (PIN) questionnaire, generated from discussions with clinicians and interviews with patients with DPN, was administered to patients with DPN attending U.K. (n = 325) and U.S. (n = 170) diabetes centers. Psychometric tests of the PIN questionnaire comprised factor analysis, internal consistency, and test-retest reliability. Partial correlations and multivariate regressions established construct and criterion-related validity. The associations of PIN scales to past foot ulceration and foot self-care behaviors were compared with those using a generic measure of illness perception and emotion, the Revised Illness Perception Questionnaire (IPQ-R), which was adapted to neuropathy. RESULTS: Factor analysis of the PIN questionnaire produced 11 scales, which explained 69% of item variance. Nine factors measured patients' common-sense beliefs about DPN and their levels of understanding of DPN-related medical information. Two factors assessed the emotions of worry about potential consequences and anger at practitioners. Most scales demonstrated adequate internal (Cronbach's alpha = 0.62-0.90) and test-retest reliability (Pearson's r = 0.51-0.64). Partial correlations between the PIN and IPQ-R scales in corresponding domains were significant but modest (rp = 0.15-0.26). Finally, PIN scales showed significant associations with past foot ulceration and foot self-care behaviors, thereby confirming criterion validity. CONCLUSIONS: The 39-item PIN questionnaire is a reliable and valid measure of patients' cognitive and emotional representations of neuropathy affecting foot self-care.

Aged↗
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

The global burden of diabetic foot disease.

Diabetic foot problems are common throughout the world, resulting in major economic consequences for the patients, their families, and society. Foot ulcers are more likely to be of neuropathic origin, and therefore eminently preventable, in developing countries, which will experience the greatest rise in the prevalence of type 2 diabetes in the next 20 years. People at greatest risk of ulceration can easily be identified by careful clinical examination of the feet: education and frequent follow-up is indicated for these patients. When assessing the economic effects of diabetic foot disease, it is important to remember that rates of recurrence of foot ulcers are very high, being greater than 50% after 3 years. Costing should therefore include not only the immediate ulcer episode, but also social services, home care, and subsequent ulcer episodes. A broader view of total resource use should include some estimate of quality of life and the final outcome. An integrated care approach with regular screening and education of patients at risk requires low expenditure and has the potential to reduce the cost of health care.

Amputation, Surgical↗
PubMed2005

Diabetic peripheral neuropathy and depressive symptoms: the association revisited.

OBJECTIVE: We examined the association between severity of diabetic peripheral neuropathy and depressive symptoms and investigated the potential mediators of this association. RESEARCH DESIGN AND METHODS: The Hospital Anxiety and Depression Scale (HADS) was used to assess depressive symptoms in 494 patients (mean age 62 years; 70% male; 72% type 2 diabetic) with diabetic neuropathy diagnosed by the Neuropathy Disability Score (NDS) and the Vibration Perception Threshold (VPT). Diabetic neuropathy symptoms, activities of daily living (ADLs), and social self-perception were measured by the neuropathy and foot ulcer-specific quality-of-life instrument, NeuroQoL; perceptions of diabetic neuropathy symptom unpredictability and the lack of effective treatment were assessed by the revised Illness Perception Questionnaire. RESULTS: Both the NDS and VPT were significantly associated with the HADS after controlling for demographic and disease variables. Although diabetic neuropathy symptoms mediated this association, with unsteadiness being most strongly associated with HADS, the relationship between foot ulceration and depression was nonsignificant. The association between diabetic neuropathy symptoms and HADS was partially mediated by two sets of psychosocial variables: 1) perceptions of diabetic neuropathy symptom unpredictability and the lack of treatment control and 2) restrictions in ADLs and changes in social self-perception. CONCLUSIONS: These findings establish the association between diabetic neuropathy and depressive symptoms and identify potential targets for interventions to alleviate depressive symptoms in persons affected by diabetic peripheral neuropathy.

Activities of Daily Living↗
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↗
PubMed2005

A randomized trial of two irremovable off-loading devices in the management of plantar neuropathic diabetic foot ulcers.

OBJECTIVE: The purpose of this study was to compare the effectiveness of a removable cast walker (RCW) rendered irremovable (iTCC) with the total contact cast (TCC) in the treatment of diabetic neuropathic plantar foot ulcers. RESEARCH DESIGN AND METHODS: In a prospective, randomized, controlled trial, 41 consecutive diabetic patients with chronic, nonischemic, neuropathic plantar foot ulcers were randomly assigned to one of two groups: a RCW rendered irremovable by wrapping it with a single layer of fiberglass casting material (i.e., an iTCC) or a standard TCC. Primary outcome measures were the proportion of patients with ulcers that healed at </=12 weeks, healing rates, complication rates, cast placement/removal times, and costs. RESULTS: The proportions of patients with ulcers that healed within 12 weeks in the iTCC and TCC groups were 80 and 74%, respectively (94 and 93%, respectively, when patients who were lost to follow-up were excluded). Survival analysis (healing rates) was statistically equivalent in the two groups, as were complication rates, but with a trend toward benefit in the iTCC group. The iTCC took significantly less time to place and remove than the TCC with 39% and 36% reductions, respectively. There was also an overall lower cost associated with the use of the iTCC compared with the TCC. CONCLUSIONS: The iTCC may be equally efficacious, faster to place, easier to use, and less expensive than the TCC in the treatment of diabetic plantar neuropathic foot ulcers.

Adult↗
PubMed2005

Efficacy of multilayered hosiery in reducing in-shoe plantar foot pressure in high-risk patients with diabetes.

OBJECTIVE: High plantar pressure is an acknowledged risk factor in the development of plantar ulcers in the diabetic neuropathic foot. This study examines the ability of preventive foot care (PFC) socks to reduce plantar foot pressures in a sample of high-risk patients with diabetes. RESEARCH DESIGN AND METHODS: Nineteen patients with established peripheral neuropathy attending a complications clinic of the Manchester Diabetes Centre were recruited to the study. Fifteen (78%) of the patients were male, 40-80 years of age, and ulcer-free at the time of recruitment. In-shoe plantar pressure measurements were recorded using the F-Scan and compared PFC socks with ordinary supermarket socks. The analysis measured differences in maximum foot contact area and plantar pressure for the whole foot, forefoot, and peak plantar pressure areas. RESULTS: The results showed a significant increase in maximum foot contact area of 11 cm2 (95% CI 7-11) when subjects wore the PFC socks (P < 0.01). This was accompanied by 5.4 kPa (3.5-7.3) or 9% reduction in total foot pressure (P < 0.01). Similar results were observed at the forefoot, which showed a 14.2% increase in contact area and a 10.2% reduction in peak forefoot pressure. CONCLUSIONS: These results suggest that the wearing of PFC socks increases the underfoot contact area and hence decreases plantar foot pressures. Further studies are required to determine whether the pressure and friction reductions achieved by this simple intervention would be effective in reducing the incidence of foot ulcers in high-risk patients.

Adult↗
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↗