Health service organisation impact on lower extremity amputations in people with type 2 diabetes with foot ulcers: systematic review and meta-analysis.

AIMS: Despite the evidence available on the epidemiology of diabetic foot ulcers and associated complications, it is not clear how specific organizational aspects of health care systems can positively affect their clinical trajectory. We aim to evaluate the impact of organizational aspects of care on lower extremity amputation rates among people with type 2 diabetes affected by foot ulcers. METHODS: We conducted a systematic review of the scientific literature published between 1999 and 2019, using the following key terms as search criteria: people with type 2 diabetes, diagnosed with diabetic foot ulcer, treated with specific processes and care pathways, and LEA as primary outcome. Overall results were reported as pooled odds ratios and 95% confidence intervals obtained using fixed and random effects models. RESULTS: A total of 57 studies were found eligible, highlighting the following arrangements: dedicated teams, care pathways and protocols, multidisciplinary teams, and combined interventions. Among them, seven studies qualified for a meta-analysis. According to the random effects model, interventions including any of the four arrangements were associated with a 29% reduced risk of any type of lower extremity amputation (OR = 0.71; 95% CI 0.52-0.96). The effect was larger when focusing on major LEAs alone, leading to a 48% risk reduction (OR = 0.52; 95% CI 0.30-0.91). CONCLUSIONS: Specific organizational arrangements including multidisciplinary teams and care pathways can prevent half of the amputations in people with diabetes and foot ulcers. Further studies using standardized criteria are needed to investigate the cost-effectiveness to facilitate wider implementation of improved organizational arrangements. Similarly, research should identify specific roadblocks to translating evidence into action. These may be structures and processes at the health system level, e.g. availability of professionals with the right skillset, reimbursement mechanisms, and clear organizational intervention implementation guidelines.

Risk assessment for foot ulcers among Tunisian subjects with diabetes: a cross sectional outpatient study.

BACKGROUND: Diabetic foot is an underestimated and redoubtable diabetes complication. The aims of our study were to assess diabetic foot ulcer risk factors according to International Working Group on the Diabetic Foot (IWGDF) classification, stratify patients into risk categories and identify factors associated with higher-risk grade. METHODS: Cross-sectional setting over a period of 07 months, patients were randomly selected from the diabetic outpatients attending our unit of diabetology. Questionnaire and clinical examination were made by the same physician. Patients free of active foot ulcer were included. RESULTS: Among 230 patients evaluated, 10 had an active foot ulcer and were excluded. Five patients (2.27%) had a history of foot ulcer and 3(1.36%) had a lower-limb amputation. Sensory neuropathy, as measured by the 5.07(10 g) Semmes-Weinstein monofilament testing, was present in 23.63% of patients, whereas 36.82% had a peripheral arterial disease based on clinical findings, and 43.63% had foot deformities. According to the IWGDF classification, Group 0: 72.72%, Group 1: 5.9%, Group 2: 17.73% and Group 3: 3.63%. After univariate analysis, patients in higher-risk groups were significantly more often female, had higher age and BMI, longer diabetes duration, elevated waist circumference, low school level, retinopathy and hyperkeratosis. Multivariate logistic regression analysis identified 3 significant independent factors associated with high-risk groups: retinopathy (OR = 2.529, CI95 [1.131-5.655], p = 0.024), hyperkeratosis (OR = 2.658, CI95 [1.222-5.783], p = 0.014) and school level (OR = 0.489, CI95 [0.253-9.44], p = 0.033). CONCLUSIONS: Risk factors for foot ulceration were rather common in outpatients with diabetes. The screening of patients at risk for foot ulceration should start early, integrated with sustainable patient education.

Assessment of Outcomes of a Metatarsal Bone Ostectomy for Chronic Plantar Ulcers: A Preliminary Study.

BACKGROUND: Clinical management of chronic plantar ulcers is a difficult issue in medical practice. Pressure overloading is a problem that needs to be resolved. Herein, we report a surgical method to reduce plantar pressure: a dorsal approach to a metatarsal ostectomy. METHODS: From March 2011 to October 2016, 16 patients suffering from chronic plantar ulcers underwent ostectomy procedures at Taipei Wan-Fang Municipal Hospital (Taipei Medical University). A bone segment about 0.5 to 1 cm long was removed via a dorsal foot approach. The plantar wound was treated with debridement only or was simultaneously covered with a skin graft. In total, 16 patients with an average age of 57.81 (SD, 11.6) years (12 males and 4 females) were included; 15 patients (93.75%) had a diagnosis of type 2 diabetes for a mean of 20.66 years (range, 5-30 years). The mean glycated hemoglobin was 9.14 g/dL (range, 5.2-13.2 g/dL). The mean plantar wound size was 5.72 cm. Four patients (25%) needed to receive a skin graft with a mean skin graft size of 8.13 cm. RESULTS: The mean follow-up time was 15.2 months. The plantar wounds completely healed in 14 patients (87.5%) in an average of 2.14 months. No plantar ulcer was complicated with recurrence, but transfer ulcers developed in 2 patients (12.5%) at an average of 7.5 months postoperatively. CONCLUSIONS: Metatarsal ostectomy surgery via a dorsal foot approach is an efficient way to reduce pressure overloading of chronic plantar wounds. Our study provides an alternative method to treat this difficult problem with a high wound healing rate and less recurrence.

In-office distal Symes lesser toe amputation: a safe, reliable, and cost-effective treatment of diabetes-related tip of toe ulcers complicated by osteomyelitis.

Diabetes-related tip of lesser toe ulcers have typically been associated with both underlying hammertoe contracture and peripheral neuropathy. The combination of digital deformity and neuropathy commonly results in non-healing, deep sores that frequently become complicated by osteomyelitis. We report on a well-known, but poorly reported, technique for surgical management of non-healing tip of lesser toe ulcers. After approval by the institutional review board, a review was performed of consecutive patients who had undergone office-based distal Symes toe amputation for a non-healing tip of lesser toe ulcer from January 2007 to December 2012. A variety of clinical, laboratory, and radiographic data were collected. A total of 48 consecutive patients (48 toe ulcers) were identified for inclusion in the present study. All patients had ulcers at the time of surgery, and no patient developed repeat ulceration of the involved digit postoperatively. Of the 48 patients, 44 (92%) had hammertoe deformity preoperatively. Also, 30 patients (63%) had positive probe-to-bone results, and 29 (97%) of these patients had culture or histologic findings positive for osteomyelitis. Of the 48 patients (48 ulcers), 73% had positive bone cultures, 69% had positive pathologic findings demonstrating osteomyelitis, and 100% had clean margins. Methicillin-resistant Staphylococcus epidermidis was the most common pathogen isolated (13 of 48, 27%). No patient required additional amputation related to the operative digit. The mean follow-up period was 28.79 months. Our results have shown that in-office distal Symes lesser toe amputation is a safe, reliable, and likely cost-effective treatment of non-healing tip of lesser toe ulcers complicated by osteomyelitis. This office-based procedure allows bone biopsy diagnosis, removes the non-healing ulcer, confirms clear margins regarding the osteomyelitis, and addresses the underlying toe deformity to minimize the chances of repeat ulceration.

Older adults with heel ulcers in the acute care setting: frequency of noninvasive vascular assessment, surgical intervention, and 1-year mortality.

OBJECTIVES: To examine how often hospitalized older adults with a diagnosis of heel ulcers are evaluated with noninvasive vascular tests and to determine the impact of invasive vascular or surgical procedures on 1-year mortality. DESIGN: Retrospective review using an electronic database and chart review of all patients discharged with a diagnosis of heel ulcer between 2006 and 2009. SETTING: Urban teaching hospital. PARTICIPANTS: A total of 506 participants aged 65 years and older. MEASUREMENTS: Data collected included resident characteristics (demographics, medical history, and severity of illness using the Charlson comorbidity index), staging of heel ulcers, rates of noninvasive vascular assessments, vascular and surgical procedures, length of stay, and 1-year mortality. RESULTS: Thirty-one percent (155/506) of patients with a heel ulcer underwent noninvasive vascular testing and of these 83% (129/155) were found to have underlying ischemia. Twenty-six percent (130/506) of patients underwent at least 1 vascular or surgical procedure. The 1-year mortality rate for patients with stage 1 or 2 disease was 55%; this rose to 70% for patients with stage 3 or 4 ulcers (P = .01), and could not be explained by differences in the Charlson comorbidity index. Patients who underwent a vascular or surgical procedure had a significantly lower mortality compared with those who did not (59% vs 68% P = .04). CONCLUSION: Older adults with a heel ulcer in the acute care setting are frequently not assessed for underlying ischemia of the lower extremities. The diagnosis carries high 1-year mortality rates. Evidence-based protocols need to be developed to determine which older adults should have a vascular assessment and then undergo an invasive procedure.

Initial clinical assessment of a novel wound management system: a case series.

The importance of exudate management for maintaining local moisture balance and avoiding maceration in the chronic wound environment is well established. The authors performed the initial clinical testing of a novel wound management system, Sepaderm (Aalnex, Inc, Irvine, California), designed to vertically wick and sequester excess exudate away from wound/periwound tissues to promote a healthy wound environment. In this series of 14 patients with lower-extremity chronic venous leg and diabetic foot ulcers, the 3-component system was well tolerated and demonstrated the ability to prevent exudate leakage onto periwound tissue and reduce existing pain and itching. All ulcers lasting 1.2 to 360 months were previously treated with standard therapies, including human cell-derived skin substitutes in some of the patients. After treatment with the new system for 7 to 174 days, 8 patients had various degrees of wound closure, ranging from 44% to 100%. The 6 patients who failed to show wound closure were treated with the new system for an average of 5.7 days, but demonstrated other clinical benefits. Future studies in larger patient populations with quantitative wound closure assessments, as well as measurements of exudate, periwound maceration, and pain management, are needed.

A retrospective assessment of partial calcanectomies and factors influencing postoperative course.

Partial calcanectomies are a common procedure for the treatment of chronic heel ulcers. We reviewed 50 cases from patients who had partial calcanectomies to determine what factors, if any, affect the rate of healing. Each case was followed up for 1 to 6 years after surgery. We found that calcanectomy wounds were difficult to heal, regardless of the etiology. We examined a multitude of factors to determine which ones affected the rate of closure, including body mass index, vascular status, preoperative albumin levels, wound grade, presence of methacillin-resistant Staphylococcus aureus, and other factors. We found that the average total closure rate for patients undergoing partial calcanectomy was between 51% and 83% after 1 year, depending on various preoperative conditions. Our data suggest that even though the procedure itself is fairly straightforward, the course of recovery is complex, with a fairly high rate of failure after 1 year. We found that preoperative infections with methacillin-resistant Staphylococcus aureus, vascular disease, albumin levels, and preoperative ulcer grade had a significant bearing on the outcomes. We also identified other factors that did not seem to affect surgical outcomes. Based on these findings, the authors suggest some factors that should be considered when performing partial calcanectomies.

Immunomodulatory role of Tinospora cordifolia as an adjuvant in surgical treatment of diabetic foot ulcers: a prospective randomized controlled study.

BACKGROUND: Chronic diabetic patients with wounds have deficient growth factors and impaired local and systemic cellular immunity. Treatment with growth factors is expensive with risk of infection transmission and these factors may not achieve optimum wound concentration. We evaluated the role of generalized immunomodulation in diabetic ulcers by using Tinospora cordifolia as an adjuvant therapy and studied its influence on parameters/determinants of healing, on bacterial eradication and on polymorphonuclear phagocytosis. MATERIALS AND METHODS: A prospective double-blind randomized controlled study lasting for over 18 months in 50 patients. The ulcer was classified by wound morphology and severity with Wound Severity Score (Pecoraro-Reiber system). Mean ulcer area, depth and perimeter were measured and swabs taken for culture. Blood was collected to assess polymorphonuclear % phagocytosis (PMN function by Lehrer-Cline C. albicans method). Medical therapy, glycemic control, debridement, wound care were optimized. At 4 weeks, parameters were reassessed. PMN function was reviewed at 3 months. RESULTS AND ANALYSIS: Forty-five patients completed the trial: study group - 23 (M:F = 17:1; mean age = 56.3 years; mean ulcer duration = 21.1 days); control group 22 (M:F = 19:3; mean age = 56.3 years; mean ulcer duration = 30.4 days). Net improvement was seen in 17 patients (73.9%) in the study group; while in the control group, in 13 patients (59.1%); P = 0.292. Specific parameters included rate of change of ulcer area - cm(2) /day (study - 0.15; control - 0.07; P = 0.145); rate of change of ulcer perimeter - mm/day (study - 0.09; control = - 0.07; P = 0.089); change of depth - mm (study - 2.2; control - 1.4; P = 0.096); change of wound score (study - 14.4; control - 10.6; P = 0.149); total number of debridements (study - 1.9; control - 2.5; P = 0.03) and change in % phagocytosis (study - 3.9; control - 2.3; P = 0.048). CONCLUSION: Diabetic patients with foot ulcers on T. cordifolia as an adjuvant therapy showed significantly better final outcome with improvement in wound healing. Reduced debridements and improved phagocytosis were statistically significant, indicating beneficial effects of immunomodulation for ulcer healing.

Incidence, outcomes, and cost of foot ulcers in patients with diabetes.

OBJECTIVE: To determine the incidence of foot ulcers in a large cohort of patients with diabetes, the risk of developing serious complications after diagnosis, and the attributable cost of care compared with that in patients without foot ulcers. RESEARCH DESIGN AND METHODS: Retrospective cohort study of patients with diabetes in a large staff-model health maintenance organization from 1993 to 1995. Patients with diabetes were identified by algorithm using administrative, laboratory, and pharmacy records. The data were used to calculate incidence of foot ulcers, risk of osteomyelitis, amputation, and death after diagnosis of foot ulcer, and attributable costs in foot ulcer patients compared with patients without foot ulcers. RESULTS: Among 8,905 patients identified with type 1 or type 2 diabetes, 514 developed a foot ulcer over 3 years of observation (cumulative incidence 5.8%). On or after the time of diagnosis, 77 (15%) patients developed osteomyelitis and 80 (15.6%) required amputation. Survival at 3 years was 72% for the foot ulcer patients versus 87% for a group of age- and sex-matched diabetic patients without foot ulcers (P < 0.001). The attributable cost for a 40- to 65-year-old male with a new foot ulcer was $27,987 for the 2 years after diagnosis. CONCLUSIONS: The incidence of foot ulcers in this cohort of patients with diabetes was nearly 2.0% per year. For those who developed ulcers, morbidity, mortality, and excess care costs were substantial compared with those for patients without foot ulcers. The results appear to support the value of foot-ulcer prevention programs for patients with diabetes.

A regional pedal ischemia scoring system for decision analysis in patients with heel ulceration.

PURPOSE: The objective of this study was to evaluate patients undergoing operative debridement for heel ulceration and to categorize pedal perfusion and its influence on therapeutic alternatives. METHODS: Patients with heel ulceration were stratified by arteriography and graded I (patent posterior tibial, PT), II (occluded PT/reconstituted from peroneal), III (PT reconstituted from dorsal pedal), IV (no PT reconstitution but visible heel tributaries), and V (avascular heel). RESULTS: From May 1992 through January 1997, 23 patients underwent operative treatment for 25 heel ulcers. The heel ischemia score stratified patients into two groups: 1, revascularization/debridement (71% grades I to III, 29% grade IV, 0% grade V); and 2, free tissue transfer with or without revascularization (100% grades IV, V). Cumulative functional limb salvage was 91% (BP), 60% (BP + TT), and 81% (TT) at 24 months (P = 0.15 log rank). CONCLUSION: The heel ischemia score may direct treatment of heel ulceration by identifying patients who will need vascularized tissue transfer early in their treatment regimen.

Economy of donor site incisions: multiple free flaps of the subscapular family for extensive extremity wounds and bilateral foot defects.

One of the most important goals of modern microsurgical reconstruction is to decrease donor site morbidity as much as possible. With free flaps for lower limb reconstruction, economy of donor sites was designed and performed in 39 patients. Among these 39 patients, 17 had multiple flaps raised from a single incision for reconstruction of multiple defects in one or both lower extremities. Microvascular reconstruction of multiple defects is a challenging problem, particularly if it is to be performed simultaneously. The patients were followed for more than 3 years. Immediate complications and long-term disabilities were analyzed. From the data we conclude that this method has the following advantages: (1) economy of donor site incisions, (2) less harvest time, and (3) availability of any composite tissue for transfer. Donor site morbidity can be reduced by good planning, careful dissection, meticulous hemostasis, and adequate postoperative management.

Improved quality of diabetic foot care, 1984 vs 1990. Reduced length of stay and costs, insufficient reimbursement.

Ischemic foot ulceration in the diabetic patient is a source of great physical and emotional strain for the patient and represents a significant financial burden for the health care system responsible for the cost of such care. Limb salvage remains the primary therapeutic goal; yet, fiscal constraints imposed by diagnosis related group-based reimbursement systems require maximal cost efficiency in the care process. Between 1984 and 1990, the changes in our team management approach to this problem, emphasizing aggressive surgical revascularization of threatened limbs, have improved the quality of care and dramatically reduced the major and minor amputation rate. In the process, we have reduced the length of hospital stay and the overall cost of care. Despite this improvement in outcome and efficiency, Medicare reimbursement remains insufficient, with an average loss of $7480 per admission.