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At least 19 recordsLinked to original sources

PubMedDate not supplied

Foot bearing pressure in patients with unilateral diabetic foot ulcers.

Foot ulceration due to neuropathy is a serious cause of morbidity in diabetes. Ulceration usually occurs at the part of the foot subjected to excessive mechanical pressure. A more generalized increase in pressure under the feet has also been shown to be a feature of many patients with diabetic neuropathy. In this study the electrodynogram was used to measure the pressure at seven positions under each foot. The maximum vertical foot bearing pressure was found to be higher in 11 diabetic patients with previously healed unilateral foot ulcers (10.6 +/- 5.9 kg cm-2) than in 11 diabetic patients who did not have such a history (4.2 +/- 1.3 kg cm-2). However there was no difference in pressure between the foot with previous ulceration and the contralateral foot (9.7 +/- 6.8 kg cm-2, 11.6 +/- 7.9 kg cm-2). Vertical foot bearing pressure was decreased by an average of 18% by wearing shoes padded with a Professional Protective Technology insole and the decrease was greater in patients with higher foot pressure. These results showed that increased vertical foot pressure is an important, but not the only, factor in determining the occurrence of foot ulcer.

Body Weight↗

PubMed2004

Optimal treatment of infected diabetic foot ulcers.

Foot ulceration can lead to devastating consequences in diabetic patients. They are not only associated with increased morbidity but also mortality. Foot infections result as a consequence of foot ulceration, which can occasionally lead to deep tissue infections and osteomyelitis; both of which can result in loss of limb. To prevent amputations prompt diagnosis and treatment is required. Understanding the pathology of the diabetic foot will help in the planning of appropriate investigations and treatment. Clinical diagnosis of infection is based on the presence of discharge from the ulcer, cellulitis, warmth and signs of toxicity; though the latter is uncommon. Deep tissue samples from the ulcer and/or blood cultures should be taken before, but without delaying the start of antibacterial treatment in limb and life-threatening infections. In milder infections wound sampling may direct appropriate antibacterial treatment. Staphylococcus aureus, followed by streptococci are the most common organisms causing infection and antibacterial treatment should be targeted against these organisms in mild infection possibly with monotherapy. But in serious infections combination therapy is required because these are usually caused by multiple organisms including anaerobes. Drug-resistant organisms are becoming more prevalent and methicillin-resistant infections can be treated effectively with a number of oral antibacterials either as monotherapy or in combination. Surgical treatment with debridement, for example, callus removal or drainage of pus form an important part of diabetic foot ulcer management especially in the presence of infection. Occasionally limited surgery including dead infected bone removal may be necessary for resolution of infection. Amputation is sometimes required as a last resort for limb or life preservation.

Anti-Bacterial Agents↗

PubMed1995

1995 William J. Stickel Gold Award. High strain rate tissue deformation. A theory on the mechanical etiology of diabetic foot ulcerations.

Foot ulcerations are one of the most common and dangerous complications associated with chronic diabetes mellitus. Many studies have focused on neuropathy, in conjunction with elevated ground reactive forces, as the principal cause of these ulcerations. The authors discuss the mechanical cause of diabetic ulcerations at the cellular level. It is hypothesized that increased rate of tissue deformation associated with foot slap secondary to progressive motor neuropathy is the actual culprit, and not the magnitude of local pressure applied. The authors present a cellular model that shows that high rates of tissue deformation may result in elevated intracellular calcium concentrations, which may lead to cellular death, while comparable loads gradually applied do not. Furthermore, there is no significant difference in the response observed at 5 psi and 10 psi. Based on these findings, it is hypothesized that techniques such as ankle foot orthoses, which control the velocity of foot strike, may be useful in treating diabetic foot ulcerations.

Awards and Prizes↗

PubMed1994

How to help diabetic patients avoid amputation. Prevention and management of foot ulcers.

Foot ulcers are a weighty complication of diabetes whose significance is often underestimated. They are associated with a high degree of morbidity and mortality, and treatment is laborious and costly. The problem of susceptibility to foot ulceration is best addressed through a prevention program emphasizing patient education, pedal hygiene, regular follow-up visits, and lifestyle modification. Such programs are most efficiently administered by a healthcare team. When ulcers do occur, it is important to take a systematic approach to management, stressing infection control, metabolic stabilization, thorough debridement, and meticulous wound care.

Amputation, Surgical↗

PubMed2003

Cost-effectiveness of becaplermin for nonhealing neuropathic diabetic foot ulcers.

Foot ulcers secondary to peripheral neuropathy and vascular disease are a commonly occurring complication for people with diabetes. Becaplermin, a genetically-engineered growth factor in a hydrogel vehicle, has been shown to be more effective than vehicle-only control in healing chronic foot ulcers of patients with adequate vasculature receiving best clinical care. To evaluate the cost-effectiveness of adding up to 20 weeks of becaplermin to a regimen of best clinical care, a 1-year decision-analytic model was developed and tested using data from a previously published controlled clinical study involving 251 people with diabetes (124 becaplermin/127 control) and adequate vasculature presenting with an infection-free ulcer that had failed to heal despite appropriate therapy. A 20-week healing rate was estimated based on the clinical trial data assuming becaplermin treatment was terminated at 10 weeks in non-responding ulcers, and follow-up data were extended to 1 year. Resource utilization was estimated by an expert panel using a modified Delphi approach. Using the model, it was found that incorporating becaplermin with best clinical care resulted in 26 fewer ulcer-days per patient per year compared to best clinical care alone with an incremental cost-effectiveness ratio of $6 per ulcer-day averted. Results were sensitive to becaplermin cost, efficacy, and effect on infection and recurrence rates. The clinical benefits of becaplermin deserve further investigation to enhance cost-effectiveness information for informed treatment decisions.

Anticoagulants↗

PubMed2003

Infections in diabetic foot ulcers.

Foot ulcers and infections are common in diabetic patients. A 30-month-long descriptive study was conducted in our hospital in which we analyzed microbiological isolates of all patients admitted with diabetic foot infections. The predominant flora identified were Staphylococcus aureus and coagulase-negative Staphylococcus, followed by Enterococcus spp., Streptococcus spp., and enterobacteriaceaes. In 27 positive cultures (42%) polymicrobial flora were found. There were only 5% anaerobic bacteria. There appears to be a relationship between the sample collection system and microbiological isolates.

Journal Article↗

PubMed2005

The comprehensive therapy of diabetic foot ulcers.

Foot wounds are a common complication of diabetes mellitus, and a significant number of them lead to amputation. Fortunately, the majority of diabetic foot wounds are preventable. In this article, we review the different factors leading to ulceration and outline the essentials of a thorough evaluation. Finally, we present the various management strategies available to the treating physician.

Bandages↗

PubMed2002

Bilayered bioengineered skin substitute (Apligraf): a review of its use in the treatment of venous leg ulcers and diabetic foot ulcers.

UNLABELLED: The bilayered bioengineered skin substitute (BBSS) [Apligraf] is used for the treatment of venous leg ulcers and diabetic foot ulcers. It has an epidermal layer formed from human keratinocytes and a dermal layer composed of human fibroblasts in a bovine type I collagen matrix. BBSS does not contain any antigen-presenting cells such as Langerhans cells, dermal dendritic cells, endothelial cells or leucocytes. In clinical trials, there was no evidence of clinical rejection and immunological tests indicated no humoral or cellular response to the keratinocytes or fibroblasts of BBSS. Further clinical trials are required to identify the exact mechanism of action of BBSS in chronic wounds. BBSS plus compression therapy was well tolerated and was superior in efficacy to compression therapy alone in a multicentre, randomised trial in patients with venous leg ulcers. At 6 months' follow-up, complete wound healing occurred in 63 versus 49% of patients and the median time to wound closure was 61 versus 181 days. In a subgroup of patients with hard-to-heal ulcers (>1 year's duration), wound healing was achieved in significantly more patients (47 vs 19%) and the median time to wound healing was significantly shorter (181 days vs not attained). In a multicentre, randomised trial, BBSS was well tolerated and effective in patients with full-thickness neuropathic diabetic foot ulcers. Ulcer healing occurred in significantly more patients (56 vs 38%) and the median time to wound healing was shorter (65 vs 90 days) with BBSS than with saline-moistened gauze at 12 weeks' follow-up. Patients in both groups also received standard diabetic foot care. The cost effectiveness of BBSS in patients with chronic ulcers has yet to be examined in well designed, prospective clinical trials. However, according to a modelled analysis incorporating data from a multicentre randomised trial, BBSS was cost effective in patients with hard-to-heal venous leg ulcers. The average annual medical cost of managing patients with ulcers of >1 year's duration was estimated to be 20,041 US dollars per patient treated with BBSS plus compression therapy and 27,493 US dollars per patient treated with compression therapy alone (1996 costs). CONCLUSIONS: Clinical trials have shown that BBSS in conjunction with standard compression therapy was effective and well tolerated in patients with venous leg ulcers, especially patients with ulcers of >6 months' duration or that extended to the subcutaneous tissue. In addition, BBSS in conjunction with standard diabetic foot care was effective and well tolerated in patients with full-thickness neuropathic diabetic foot ulcers. BBSS represents a useful adjuvant to standard ulcer therapy in patients with venous leg ulcers or full-thickness neuropathic diabetic foot ulcers that do not respond to conventional ulcer therapy.

Clinical Trials as Topic↗

PubMed2000

Pressure relieving interventions for preventing and treating diabetic foot ulcers.

BACKGROUND: Foot ulceration is thought to affect 15% of all people with diabetes at some time during their life. OBJECTIVES: To assess the effectiveness of pressure relieving interventions in the prevention and treatment of diabetic foot ulcers. SEARCH STRATEGY: Searches of 19 databases, hand searching of journals, bibliographies and identification of unpublished work by written communication with recognised experts in the diabetic foot. SELECTION CRITERIA: Randomised controlled trials evaluating pressure relieving interventions either in the prevention or the treatment of diabetic foot ulcers. There was no restriction on articles/trials based on language or publication status. DATA COLLECTION AND ANALYSIS: Data extraction and assessment of study quality was undertaken by two reviewers independently. Each trial was analysed separately, no pooling of results was possible due to the difference in patients, comparisons and outcomes. MAIN RESULTS: Prevention 4 RCTs of pressure relieving interventions were identified. Interventions for the prevention of diabetic foot ulcers indicated that in-shoe orthotics are of benefit. The relative merits of different in-shoe orthotics are unclear; cushioning and pressure redistribution appear of equal benefit. Other pressure relieving interventions such as running shoes have not been adequately evaluated and removable casts (Scotchcast or Hope) or foam inlays do not appear to have been evaluated at all in randomised controlled studies. Treatment 1 RCT of total contact casting indicated that it was effective in the treatment of diabetic ulcers although the evidence was limited. REVIEWER'S CONCLUSIONS: Prevention There is limited evidence of the effectiveness of orthotic interventions over removal of callus. There is some evidence evaluating the relative effectiveness of two types orthotic devices. There is very limited evidence of the effectiveness of therapeutic shoes. Treatment There is very limited evidence of the effectiveness of total contact casts in the treatment of diabetic foot ulcers. Overall there is a need to measure the effectiveness of the range of pressure relieving interventions for the prevention and treatment of diabetic foot ulcers as there is a small amount of poor quality research in this area.

Casts, Surgical↗

PubMed1996

The role of diabetic neuropathy and high plantar pressures in the pathogenesis of foot ulceration.

Diabetic foot ulceration is currently a serious medical problem and has, therefore, attracted much research attention during the last two decades. Previous foot ulceration, diabetic neuropathy, limited joint mobility, high plantar pressures, microangiopathy, macroangiopathy and diabetic nephropathy have already been identified as risk factors for future foot ulceration. Neuropathy has clearly been shown to be an essential permissive factor in the development of ulceration in the non-ischaemic foot. Moreover, the pathogenetic role of high plantar pressures is crucial in the presence of established clinical neuropathy. Nowadays, our therapeutic efforts clearly aim to prevent than treat foot ulcers. This demands specialist and team work in the setting up of a diabetic foot clinic in an attempt to identify and educate the diabetic patients at risk and, where possible to use suitable plantar pressure-reducing systems (footwear, hosiery etc.). Then only would it be reasonable to postulate that a significant reduction in amputations of diabetic aetiology could be achieved in the near future.

Diabetic Neuropathies↗

PubMed2002

Debridement of diabetic foot ulcers.

BACKGROUND: Foot ulceration is thought to affect 15% of people with diabetes at some time in their lives. OBJECTIVES: The aim of this review is to assess the evidence for the effectiveness of debridement as a treatment for diabetic foot ulcers. SEARCH STRATEGY: Searches of electronic databases, hand searching journals, bibliographies and identification of unpublished work by written communication with recognised experts in the diabetic foot. SELECTION CRITERIA: Randomised controlled trials evaluating a method of debridement in the treatment of diabetic foot ulcers. The outcome had to include either complete healing or rate of healing. There was no restriction on articles/trials based on language or publication status. DATA COLLECTION AND ANALYSIS: Data extraction and assessment of study quality were undertaken by one reviewer and checked by an Editor of the Wounds Group. MAIN RESULTS: 5 RCTs of debridement were identified; 3 RCTs assessed the effectiveness of a hydrogel as a debridement method, 1 RCT evaluated surgical debridement and 1 RCT evaluated larval therapy. Pooling the 3 hydrogel RCTs suggested that hydrogels are significantly more effective than gauze or standard care in healing diabetic foot ulcers (absolute risk difference 0.23; 95% CI: 0.10,0.36). Surgical debridement and larval therapy showed no significant benefit in these small trials. Other debridement methods such as enzyme preparations or polysaccharide beads have not been evaluated in RCTs of people with diabetes. REVIEWER'S CONCLUSIONS: There is evidence to suggest that hydrogel increases the healing rate of diabetic foot ulcers. More research is needed to evaluate the effects of a range of widely used debridement methods and of debridement per se.

Combined Modality Therapy↗

PubMed2026

Development of a core descriptor set for studies assessing interventions for diabetes-related foot ulceration.

AIMS/HYPOTHESIS: Foot ulceration is a common complication of diabetes and is associated with high mortality and costs. The quality of evidence to inform clinical practice is limited, partly because clinical studies do not consistently report baseline participant characteristics. This study aimed to develop a core descriptor set (CDS), a minimum set of descriptors to be measured in all studies evaluating interventions for people with diabetes-related foot ulceration. METHODS: A longlist of descriptors was generated through a systematic review of studies assessing interventions for diabetes-related foot ulcers, pre-registered with PROSPERO (CRD42019128250). The identified descriptors were then ranked based on perceived importance by healthcare professionals from different fields and geographical locations using a nine-point Likert scale in the first round of a Delphi survey. Using standardised criteria, descriptors without consensus were re-ranked in round two. Critical descriptors and those without consensus after the Delphi process were discussed in the consensus meeting to finalise the CDS. RESULTS: The systematic review yielded 95 candidate descriptors. The two Delphi rounds were completed by 102 and 69 healthcare professionals, respectively. The Delphi process identified 34 critically important descriptors and 13 descriptors without consensus, which were discussed in the consensus meeting. The ratified CDS included 28 descriptors across nine domains: demographic variables; individual factors; ulcer characteristics; limb characteristics; ongoing medical interventions; previous surgical interventions; medication history; biochemical measurements; and quality of life/function/symptoms. CONCLUSIONS/INTERPRETATION: This CDS reflects characteristics important to health professionals and researchers when reporting clinical studies on diabetes-related foot ulceration. Its use will aid the reporting of future studies.

Humans↗

PubMed1999

A prospective study of risk factors for diabetic foot ulcer. The Seattle Diabetic Foot Study.

OBJECTIVE: Little prospective research exists on risk factors for diabetic foot ulcer that considers the independent effects of multiple potential etiologic agents. We prospectively studied the effects of diabetes characteristics, foot deformity, behavioral factors, and neurovascular function on foot ulcer risk among 749 diabetic veterans with 1,483 lower limbs. RESEARCH DESIGN AND METHODS: Eligible subjects included all diabetic enrollees of a general internal medicine clinic without foot ulcer, of whom 83% agreed to participate. Baseline assessment included history and lower-limb physical examination, tests for sensory and autonomic neuropathy, and measurements of macro- and microvascular perfusion in the foot. Subjects were followed for the occurrence of a full thickness skin defect on the foot that took > 14 days to heal, with a mean follow-up of 3.7 years. RESULTS: Using stepwise Cox regression analysis, the following factors were independently related to foot ulcer risk: foot insensitivity to the 5.07 monofilament (relative risk [95% CI]) 2.2 (1.5-3.1), past history of amputation 2.8 (1.8-4.3) or foot ulcer 1.6 (1.2-2.3), insulin use 1.6 (1.1-2.2), Charcot deformity 3.5 (1.2-9.9), 15 mmHg higher dorsal foot transcutaneous PO2 0.8 (0.7-0.9), 20 kg higher body weight 1.2 (1.1-1.4), 0.3 higher ankle-arm index 0.8 (0.7-1.0), poor vision 1.9 (1.4-2.6), and 13 mmHg orthostatic blood pressure fall 1.2 (1.1-1.5). Higher ulcer risk was associated with hammer/claw toe deformity and history of laser photocoagulation in certain subgroups. Unrelated to foot ulcer risk in multivariate models were diabetes duration and type, race, smoking status, diabetes education, joint mobility, hallux blood pressure, and other foot deformities. CONCLUSIONS: Certain foot deformities, reduced skin oxygenation and foot perfusion, poor vision, greater body mass, and both sensory and autonomic neuropathy independently influence foot ulcer risk, thereby providing support for a multifactorial etiology for diabetic foot ulceration.

Amputation, Surgical↗

PubMed2006

Silver based wound dressings and topical agents for treating diabetic foot ulcers.

BACKGROUND: Foot ulceration affects 15-20% of people with diabetes. It is a major precursor to amputation in this patient group, and early and appropriate treatment provides the greatest opportunity for healing. The use of silver for its antimicrobial properties has re-emerged, and modern wound dressings that release a sustained amount of free silver ions, are now widely used in wound management. OBJECTIVES: To evaluate the effects of silver-containing dressings and topical agents on infection rates and healing of diabetes related foot ulcers. SEARCH STRATEGY: Searches were made of the Cochrane Wounds Group Specialised Register (August 2005), the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library Issue 3 2005) MEDLINE (1966 to October week 2 2004), EMBASE (1980 to October week 2 2004) and CINAHL (1982 to October week 2 2004). The Journal of Wound Care (Volume 12/13 Issues 1-10) was hand-searched. Manufacturers, researchers and local and international wound groups were contacted in order to identify unpublished trials. Web sites for wound groups and World Wide Wounds (www.worldwidewounds.com) were searched. SELECTION CRITERIA: Randomised controlled trials and non-randomised controlled clinical trials were considered for inclusion. Studies were included if they involved participants with Type 1 or Type 2 diabetes and related foot ulcers, met the requirements for randomisation, allocation and concealment where appropriate, and compared the intervention with a placebo or a sham dressing, an alternative non silver based dressing or no dressing, and reported outcomes that represent healing rate or infection. DATA COLLECTION AND ANALYSIS: Two authors independently evaluated the papers identified by the search strategy against the inclusion criteria but identified no trials eligible for inclusion in the review. It was not possible to perform planned subgroup and sensitivity analysis in the absence of data. In future, if eligible trials become available, a random effects model will be applied for meta-analysis in the presence of statistical heterogeneity (estimated using the I(2) statistic). Dichotomous outcomes will be reported as risk ratios with 95% confidence intervals (CI), and continuous outcomes as weighted mean differences (WMD) with 95% CI. Statistical significance will be set at P value < 0.05 for all outcomes and the magnitude of the effect will be estimated by calculating the number needed to treat (NNT) with 95% CI. MAIN RESULTS: No studies were identified that met with the inclusion criteria AUTHORS' CONCLUSIONS: Despite the widespread use of dressings and topical agents containing silver for the treatment of diabetic foot ulcers, no randomised trials or controlled clinical trials exist that evaluate their clinical effectiveness. Trials are needed to determine clinical and cost-effectiveness and long term outcomes including adverse events.

Administration, Topical↗

PubMedDate not supplied

The causes and management of foot ulceration.

Managing foot ulceration is a challenge for all concerned. This article argues that the key to successful management of ulceration lies with the accurate identification of the underlying cause of the ulcer and consideration of the additional factors that are likely to impair healing. The common causes of foot ulceration are discussed, the means of evaluation and assessment are outlined and appropriate management strategies are identified. As with all care pathways, patient concordance is essential in reaching successful clinical outcomes and foot ulceration is no exception.

Diabetic Foot↗

PubMed1996

Prevention and care of diabetic foot ulcers.

The foot is frequently overlooked in the management of diabetic patients. Failure to control diabetic foot ulcers at an early stage can lead to life-threatening infection or amputation. Preventive care should emphasize patient education, glycemic control, careful daily foot hygiene and appropriate footwear. Early management of a diabetic foot ulcer should include culture-directed antibiotic therapy when there is evidence of infection, moist dressings and adjustment of footwear or casting to avoid pressure on the wound site. All patients with foot ulcers should be evaluated for evidence of foot ischemia. Surgical intervention to debride infected tissue and bone or to revascularize ischemic tissue can aid in ulcer healing. Serious infection or severe ischemia, unfortunately, often necessitates amputation.

Diabetic Foot↗

PubMed2000

[New developments in the treatment of diabetic foot ulcers].

Diabetic foot ulcers are frequent: 12,000 Dutch diabetes patients have such an ulcer. The ulcers have a multifactorial aetiology: polyneuropathy, biomechanical stress, infection, deficient footwear and to a less extent ischaemia are the major factors. The principles of ulcer treatment are relief of pressure, restoration of skin perfusion, treatment of infection, intensive wound care, metabolic control, treatment of comorbidity, and instruction of the patient. Wound healing is slow. The impaired wound healing is probably caused by deficiencies in local growth factors, changes in the extracellular matrix, diminished fibroblast function, decreased antimicrobial activity of leukocytes and disturbances in the macro- and microcirculation. In recent years several new treatment strategies have been developed to stimulate wound healing in diabetic foot ulcers. These (partly experimental) treatments include: topical growth factors, extracellular matrix products, bioengineered human skin, granulocyte colony stimulating factor and hyperbaric oxygen therapy. In particular recombinant human platelet derived growth factor (becaplermin) has proved to be clinically effective in chronic neuropathic foot ulcer and has been approved in the Netherlands.

Becaplermin↗

PubMed2006

Emerging drugs for diabetic foot ulcers.

Diabetic foot ulceration results from factors extrinsic to the foot such as repeated trauma, ischaemia and infection, as well as intrinsic factors that lead to impairment of wound healing. Intrinsic factors are less well understood, but include deficiency of growth factors, changes in extracellular matrix components with excess proteases, reduced fibroblast activity, cellular abnormalities, deficiencies of angiogenesis, nitric oxide abnormalities and hyperglycaemia. The scientific rationale of therapy is to correct both the external factors that cause diabetic foot ulcers and the internal factors that lead to impairment of wound healing. Current research is leading to new therapies that can be divided into the following classes: growth factors, skin substitutes, extracellular matrix proteins, stem cell therapy, gene therapy, protease inhibitors, angiogenesis stimulants, nitric oxide-releasing agents, adenosine agonists, immunostimulants, vasoactive compounds and granulating agents. These therapies should be considered when existing treatments to correct extrinsic factors have failed to heal ulceration in the diabetic foot.

Diabetic Foot↗