Cost of Treatment of Neuroischemic Ulcers of the Lower Extremity in Patients with Peripheral Artery Disease in the United States.

BACKGROUND: We evaluated the cost of treating neuroischemic ulcers of the lower extremity in patients with peripheral artery disease by using medical and hospital claims records submitted for reimbursement to payers (private insurance, Medicare, Medicaid). METHODS: Adjudicated claims and remittance data on claims that include submitted charges, line items paid by insurers directly to providers and patient payments of copays, deductibles and co-insurance were used. Eligible patients from a commercial database containing more than 60% of US patients with health insurance were analyzed. Patient selection, performed using International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes, yielded a study population of 42,837 unique anonymized patients. RESULTS: Using the metric of "submitted charges" to overcome differences in levels of reimbursement across insurance payers and Medicare/Medicaid, we identified 34,348 patients with ulcers with an average treatment cost of $94,100 per patient ($41,800 annualized) The costliest ulcer subtype was nonpressure ulcer of the heel/midfoot among 13,184 patients with $121,400 per patient ($53,900 annualized), 29% higher than across all ulcer types. The subset of 22,281 ulcer patients who also had a surgical procedure incurred costs of $121,000 per patient ($53,800 annualized). The costliest surgical codes were complications of vascular prosthetic devices, implants, grafts among 6444 patients with $146,900 per patient ($65,300 annualized). The combination of most expensive ulcer and most expensive surgery yielded a cohort of 2355 patients with the highest average cost of $177,400 per patient ($78,800 annualized). CONCLUSIONS: The resource burden for management of neuroischemic ulcers of the lower extremity in patients with peripheral artery disease is substantial. Mitigating this burden may help reduce significant resource utilization.

Staged salvage of diabetic foot with Chopart amputation and intramedullary nailing.

We present a stepwise surgical approach that can be used, in lieu of a transtibial amputation, to preserve the lower limb in the setting of severe diabetic foot infections. A 63-year-old male status post left midfoot (Lisfranc's) amputation presented to our hospital with a 4-year history of a left foot diabetic ulcer with associated purulent drainage and intermittent chills. On initial exam, the patient's left foot amputation stump was plantarflexed, grossly erythematous, and edematous. The associated diabetic foot ulcer was actively draining purulent fluid. Following workup with radiography and ultrasound, the patient was diagnosed with a post-operative infection of the midfoot at the level of the amputation stump secondary to diabetic neuropathy. Our approach to management was a staged and included (1) surgical irrigation and debridement of the distal stump wound, (2) provisional negative pressure therapy, (3) a second-look procedure, and (4) a tibiotalocalcaneal fusion was performed using a lateral transfibular and plantar approach, after wound closure and resolution of active infection was achieved. At 36-month follow-up, the patient was fully weight-bearing in stiff sole sneakers with no gross overt alteration of gait pattern. The patient scored 79 points when assessed by the hindfoot American Orthopaedic Foot and Ankle Society Ankle-Hindfoot outcome score. In the patient with diabetes and cardiological restrictions, a Chopart amputation is preferred due to the decreased level of energy expenditure required for ambulation as compared to over more proximal levels of amputation.

Development and validation of a pocket guide for the prevention of diabetic foot ulcers.

OBJECTIVE: Diabetic foot ulcers can have serious consequences, including amputation. This project aimed to develop and validate a diabetes care management model-a pocket guide on the prevention of foot ulceration to assist health professionals and scientific societies. METHODS: An adaptation of the Iowa method of evidence-based practice to promote high-quality care was employed. After problems are identified, the Iowa method supports the development of an action plan for addressing them. An evidence-based protocol based on the five cornerstones of the 2015 guidance on the diabetic foot by the International Working Group on the Diabetic Foot was developed in two phases and validated using the Delphi technique. RESULTS: A model was developed to promote these five cornerstones, which are the main recommendations for managing the diabetic foot. These are: foot examination; risk assessment for ulceration; education in diabetes; appropriate footwear; and treatment of pre-ulcerative lesions. To adapt this into a health information document, the management model was synthesised and designed as a pocket guide. The model's individual and global content validity indices surpass 0.78 and 0.90 respectively. CONCLUSION: A management model was created and validated, and produced as a pocket guide to deliver instructions on the care and prevention of diabetic foot problems in people with diabetes.

Nationwide prevalence and clinical characteristics of inpatient diabetic foot complications: A Peruvian multicenter study.

OBJECTIVE: To evaluate the burden of diabetic foot complications amongst inpatients in Peru. MATERIALS AND METHODS: Cross-sectional multicenter study, performed in public hospitals, in one-day enrollment between October and December 2018. RESULTS: We included 8346 patients from 39 national hospitals. Diabetic foot (DF) inpatient point prevalence was 2.8% (CI 95% 2.4-3.1), and DF point prevalence among Diabetes Mellitus (DM) inpatients was 18.9% (CI 95% 16.7-21.1). DF prevalence was higher in jungle and coastal hospitals than highlands ones, and there was no difference according to its care complexity level. Of the 234 patients with DF, 73% were males, age average was 62 ± 12 years, with DM mean time duration of 15 ± 9.9 years. Regarding to DF etiology, 91% and 68% had some degree of peripheral neuropathy and peripheral artery disease, respectively. According to the Infectious Diseases Society of America criteria, 61% presented moderate to severe infections, and 40% had bone involvement. Debridement within 48 h was performed in 36% of sepsis cases. CONCLUSION: Peru has a substantial burden of DF disease, with a greater share of that burden falling on less equipped hospitals in the country's jungle and coastal regions. Interdisciplinary teams and pathways may improve the time of surgical debridement in the highest risk patients.

Foot thermometry with mHeath-based supplementation to prevent diabetic foot ulcers: A randomized controlled trial.

Background: Novel approaches to reduce diabetic foot ulcers (DFU) in low- and middle-income countries are needed. Our objective was to compare incidence of DFUs in the thermometry plus mobile health (mHealth) reminders (intervention) vs. thermometry-only (control). Methods: We conducted a randomized trial enrolling adults with type 2 diabetes mellitus at risk of foot ulcers (risk groups 2 or 3) but without foot ulcers at the time of recruitment, and allocating them to control (instruction to use a liquid crystal-based foot thermometer daily) or intervention (same instruction supplemented with text and voice messages with reminders to use the device and messages to promote foot care) groups, and followed for 18 months. The primary outcome was time to occurrence of DFU. A process evaluation was also conducted. Results: A total of 172 patients (63% women, mean age 61 years) were enrolled; 86 to each study group. More patients enrolled in the intervention arm had a history of previous DFU (66% vs. 48%). Follow-up for the primary endpoint was complete for 158 of 172 participants (92%). Adherence to ≥80% of daily temperature measurements was 87% (103 of 118) among the study participants who returned the logbook. DFU cumulative incidence was 24% (19 of 79) in the intervention arm and 11% (9 of 79) in the control arm. After adjusting for history of foot ulceration and study site, the hazard ratio (HR) for DFU was 1.44 (95% CI 0.65, 3.22). Conclusions: In our study, conducted in a low-income setting, the addition of mHealth to foot thermometry was not effective in reducing foot ulceration. Importantly, there was a higher rate of previous DFU in the intervention group, the adherence to thermometry was high, and the expected rates of DFU used in our sample size calculations were not met. Trial registration: ClinicalTrials.gov NCT02373592 (27/02/2015).

Quantitative Studies of Diabetic Foot Ulcer Evolution Under Treatment by Digital Stereotactic Photography.

BACKGROUND: Imaging the lower extremity reproducibly and accurately remains an elusive goal. This is particularly true in the high risk diabetic foot, where tissue loss, edema, and color changes are often concomitant. The purpose of this study was to evaluate the reproducibility of a novel and inexpensive stereotaxic frame in assessment of wound healing. METHODS: The main idea is to keep constant and reproducible the relative position of extremities related to the sensor used for the examination during a serial studies by stereotaxic digital photographic sequence. Ten healthy volunteers were evaluated at 10 different time moments to estimate the foot position variations in the stereotaxic frame. The evolution of 40 of DFU patients under treatment was evaluated before and during the epidemical grow factor intralesional treatment. RESULTS: The wound closing and granulation speeds, the relative contribution of the contraction and tissue restauration mechanism were evaluated by stereotaxic digital photography. CONCLUSIONS: The results of this study suggest that the stereotaxic frame is a robust platform for serial study of the evolution of wound healing which allow to obtain consistent information from a variety of visible and hyperspectral measurement technologies. New stereotaxic digital photography evidences related to the diabetic foot ulcer healing process under treatment has been presented.

The use of bioactive glass S53P4 in the treatment of an infected Charcot foot: a case report.

OBJECTIVE:: To report a case of successful limb-salvage staged treatment in the treatment of an infected diabetic Charcot foot. CASE SUMMARY:: A 45-year-old male with long-term, uncontrolled type 2 diabetes, six months' history of progressive deformity on the right foot and 45 days of purulent drainage in the lateral aspect of the foot. Patient was diagnosed with an infected Charcot foot with extensive midfoot bone involvement as shown by radiographic and MRI images. We used a multidisciplinary approach to treatment with early antibiotic therapy, tight glycaemic control and staged surgical treatment. Initial treatment was adequate irrigation and debridement, bone-void filling with bioactive glass, external fixation and provisional negative pressure wound therapy (NPWT). Later progressed to total contact casting and progressive protect weight bearing. At final follow-up, patient was full weight-bearing in stiff soled footwear, with no clinical signs of infection, no gross alteration of gait pattern and demonstrating complete bone healing and integration of the bioactive glass. CONCLUSION:: The bioactive glass S53P4 was successfully used in the limb-salvage staged treatment of a patient with an infected Charcot foot. Here, full integration with the surrounding bone and its supportive action in the combat of bone infection was demonstrated.

Diabetic limb salvage procedure with bone allograft and free flap transfer: a case report.

The aim of this case report was to describe a successful diabetic limb salvage procedure in the treatment of an infected diabetic foot ulcer through a multidisciplinary team approach and complex surgical reconstruction involving a femoral head bone allograft and musculocutaneous latissimus dorsi free flap. The decision to proceed with aggressive staged efforts at diabetic limb salvage should be made only after careful consultation with the patient, his or her family, and the rest of the multidisciplinary healthcare team.

Healing enhancement of diabetic wounds by locally infiltrated epidermal growth factor is associated with systemic oxidative stress reduction.

The diabetic foot ulcer (DFU) is the leading cause of lower extremity amputation worldwide and is directly associated with comorbidity, disability and mortality. Oxidative stress mechanisms have been implicated in the pathogenesis of these wounds. Intra-lesional infiltration of epidermal growth factor has emerged as a potential therapeutic alternative to allow for physiological benefit while avoiding the proteolytic environment at the centre of the wound. The aim of this study was to characterise the response of patients with DFUs to epidermal growth factor treatment in terms of redox status markers. Experimental groups included patients with DFUs before and 3-4 weeks after starting treatment with epidermal growth factor; compensated and non-compensated diabetic patients without ulcers; and age-matched non-diabetic subjects. Evaluations comprised serum levels of oxidative stress and antioxidant reserve markers. Patients with DFUs exhibited the most disheveled biochemical profile, with elevated oxidative stress and low antioxidant reserves, with respect to non-ulcerated diabetic patients and to non-diabetic subjects. Epidermal growth factor intra-lesional administration was associated with a significant recovery of oxidative stress and antioxidant reserve markers. Altogether, our results indicate that epidermal growth factor intra-ulcer therapy contributes to restore systemic redox balance in patients with DFUs.

Implementation of foot thermometry plus mHealth to prevent diabetic foot ulcers: study protocol for a randomized controlled trial.

BACKGROUND: Diabetic foot neuropathy (DFN) is one of the most important complications of diabetes mellitus; its early diagnosis and intervention can prevent foot ulcers and the need for amputation. Thermometry, measuring the temperature of the feet, is a promising emerging modality for diabetic foot ulcer prevention. However, patient compliance with at-home monitoring is concerning. Delivering messages to remind patients to perform thermometry and foot care might be helpful to guarantee regular foot monitoring. This trial was designed to compare the incidence of diabetic foot ulcers (DFUs) between participants who receive thermometry alone and those who receive thermometry as well as mHealth (SMS and voice messaging) over a year-long study period. METHODS/DESIGN: This is an evaluator-blinded, randomized, 12-month trial. Individuals with a diagnosis of type 2 diabetes mellitus, aged between 18-80 years, having a present dorsalis pedis pulse in both feet, are in risk group 2 or 3 using the diabetic foot risk classification system (as specified by the International Working Group on the Diabetic Foot), have an operating cell phone or a caregiver with an operating cell phone, and have the ability to provide informed consent will be eligible to participate in the study. Recruitment will be performed in diabetes outpatient clinics at two Ministry of Health tertiary hospitals in Lima, Peru. INTERVENTIONS: participants in both groups will receive education about foot care at the beginning of the study and they will be provided with a thermometry device (TempStat™). TempStat™ is a tool that captures a thermal image of the feet, which, depending on the temperature of the feet, shows different colors. In this study, if a participant notes a single yellow image or variance between one foot and the contralateral foot, they will be prompted to notify a nurse to evaluate their activity within the previous 2 weeks and make appropriate recommendations. In addition to thermometry, participants in the intervention arm will receive an mHealth component in the form of SMS and voice messages as reminders to use the thermometry device, and instructions to promote foot care. OUTCOMES: the primary outcome is foot ulceration, evaluated by a trained nurse, occurring at any point during the study. DISCUSSION: This study has two principal contributions towards the prevention of DFU. First, the introduction of messages to promote self-management of diabetes foot care as well as using reminders as a strategy to improve adherence to daily home-based measurements. Secondly, the implementation of a thermometry-based strategy complemented by SMS and voice messages in an LMIC setting, with wider implications for scalability. TRIAL REGISTRATION: This study is registered in ClinicalTrials.gov: Identifier NCT02373592 .

Expression of cell proliferation cycle negative regulators in fibroblasts of an ischemic diabetic foot ulcer. A clinical case report.

Wound chronification and opportunistic infections stand as major factors leading to lower extremities amputations in diabetes. The molecular mechanisms underlying diabetic's torpid healing have not been elucidated. We present the case of a female diabetic patient that after a plantar abscess surgical drainage, tight glycaemia control and infection clearance; the wound bed evolved to chronification with poor matrix accumulation, scant angiogenesis and no evidence of dermo-epidermal contours contraction. Ulcer fibroblasts yet cultured under 'physiological' conditions exhibited a slow and declining proliferative response. Diabetic fibroblasts cycle arrest occurred earlier than non-diabetic counterparts. This in vitro premature arrest-senescence phenotype appeared related to the transcriptional upregulation of p53 and the proto-oncogene c-myc; with a concomitant expression reduction of the survival and cellular growth promoters Akt and mTOR. Importantly, immunocytochemistry of the diabetic ulcer-derived fibroblasts proved nuclear over expression of potent proliferation inhibitors and pro-senescence proteins as p53 phosphorylated on serine-15 and p21(Cip) (1). In line with this, cyclin D1 appeared substantially underexpressed in these cells. We postulate that the downregulation of the Akt/mTOR/cyclin D1 axis by the proximal activation of p53 and p21 due to stressor factors, impose an arrest/pro-senescence programme that translated in a torpid and slow healing process.

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.

Maggot debridement therapy: a primer.

Treatment of chronic wounds of the lower extremity requires a systematic, multidisciplinary approach as well as flexibility in order to achieve acceptable, consistent short-term and long-term results. Maggots, once considered an obsolete therapeutic modality, can be a useful addition to the armamentarium of the foot and ankle specialist. This article describes the use of maggot debridement therapy for intractable wounds of the lower extremity.