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The goal of this multicentre study was to evaluate whether circulating endothelial precursor cells and microparticles can predict diabetic foot ulcer healing by the 16th week of care. We enrolled 207 subjects, and 40.0% (28.4, 41.5) healed by the 16th week of care. Using flow cytometry analysis, several circulating endothelial precursor cells measured at the first week of care were associated with healing after adjustment for wound area and wound duration. For example, CD34+CD45dim, the univariate odds ratio was 1.19 (95% confidence interval: 0.88, 1.61) and after adjustment for wound area and wound duration, the odds ratio was (1.67 (1.16, 2.42) p = 0.006). A prognostic model using CD34+ CD45dim, wound area, and wound duration had an area under the curve of 0.75 (0.67, 0.82) and CD34+ CD45dim per initial wound area, an area under the curve of 0.72 (0.64, 0.79). Microparticles were not associated with a healed wound. Previous studies have indicated that circulating endothelial precursor cells measured at the first office visit are associated with a healed diabetic foot ulcer. In this multicentred prospective study, we confirm this finding, show the importance of adjusting circulating endothelial precursor cells measurements by wound area, and show circulating endothelial precursor cells per wound area is highly predictive of a healed diabetic foot ulcer by 16th week of care. [ABSTRACT FROM AUTHOR]

Diabetic foot ulcers (DFU) are a critical problem for those with diabetes mellitus. Predicting the healing likelihood of a DFU is important to implementing appropriate care, allocating resources, having access to advanced therapies, having successful clinical trials, calibrating clinical trial results, and providing information to administrative entities on patient and provider outcomes. Prognostic modelling can also be important when attempting to compare results across trials or care centres. In a prospective cohort study, we demonstrate and replicate that simple wound characteristics like wound area and wound duration can be used to predict wound healing by the 16th week of care. The models were based on previous literature and replicated using a machine learning algorithm. The use of wound duration and wound area in a prognostic model continues to be important when comparing study results, centre‐based outcomes, as well as designing clinical trials. [ABSTRACT FROM AUTHOR]

Chronic, nonhealing wounds consume a great deal of healthcare resources and are a major public health problem, associated with high morbidity and significant economic costs. Skin grafts are commonly used to facilitate wound closure. The grafts can come from the patient's own skin (autograft), a human donor (allograft), or from a different species (xenograft). A fish skin xenograft from cold‐water fish (Atlantic cod, Gadus morhua) is a relatively recent option that shows promising preclinical and clinical results in wound healing. Chronic wounds vary greatly in etiology and nature, requiring large cohorts for effective comparison between therapeutic alternatives. In this study, we attempted to imitate the status of a freshly debrided chronic wound by creating acute full‐thickness wounds, 4 mm in diameter, on healthy volunteers to compare two materials frequently used to treat chronic wounds: fish skin and dHACM. The purpose is to give an indication of the efficacy of the two therapeutic alternatives in the treatment of chronic wounds in a simple, standardized, randomized, controlled, double‐blind study. All volunteers were given two identical punch biopsy wounds, one of which was treated with a fish skin graft and the other with dehydrated human amnion/chorion membrane allograft (dHACM). In the study, 170 wounds were treated (85 wounds per group). The primary endpoint was defined as time to heal (full epithelialization) by blinded assessment at days 14, 18, 21, 25, and 28. The superiority hypothesis was that the fish skin grafts would heal the wounds faster than the dHACM. To evaluate the superiority hypothesis, a mixed Cox proportional hazard model was used. Wounds treated with fish skin healed significantly faster (hazard ratio 2.37; 95% confidence interval: (1.75–3.22; p = 0.0014) compared with wounds treated with dHACM. The results show that acute biopsy wounds treated with fish skin grafts heal faster than wounds treated with dHACM. [ABSTRACT FROM AUTHOR]

The purpose of this study was to explore perceptions among people with type 2 diabetes about foot ulcers and lower extremity amputations. This was a qualitative observational study utilizing open-ended, semistructured interviews of 39 people with diabetes who were purposively selected because they had either a foot ulcer ( n = 19) or a lower extremity amputation ( n = 20). Interviews were audio-recorded, deidentified, and entered into NVivo 10.0 for coding and analysis. Our integrated analytic approach combined inductively and deductively derived codes that were applied to all transcripts. Coded data were summarized and examined for patterns. Participants' description of the relationship between diabetes and their foot ulcer or amputation revealed a limited understanding of the disease process. Disruption and loss of independence was expressed whether the person had a foot ulcer or an amputation. Treatment recommendations for foot ulcers were viewed by most as extremely difficult. Amputation was a feared outcome, but some learned to adapt and, at times felt that the amputation enhanced their quality of life. Clinicians have assumed that a focus on limb salvage is preferred over a major amputation. However, because of the complexity of care requiring frequent healthcare provider visits, the frequency of care failure, the frequency of recurrence, and mortality associated with having had a foot ulcer, it may be more appropriate for clinicians to prioritize quality-of-life salvage. Foot ulcer treatment failure may be due to a lack of providers' understanding of the impact of treatment on a patient's life. [ABSTRACT FROM AUTHOR]

It is unclear why many with diabetes develop foot ulcers (DFU) and why some do not heal. It could be associated with genetic variation. We have previously shown that NOS1AP variation is associated with lower extremity amputation in those with diabetes and that circulating stem progenitor cell concentration (SPC) is associated with impaired foot ulcer healing in those with diabetes. The goal of this study was to determine if NOS1AP variation is associated with impaired wound healing and with SPC mobilization in those with DFU. In longitudinal cohort study we demonstrate that NOS1AP variants rs16849113 and rs19649113 are associated with impaired wound healing and with SPC mobilization in those with DFU. We believe that further study of NOS1AP is merited and that it NOS1AP might be associated with a functional impairment. [ABSTRACT FROM AUTHOR]

The present status of clinical leg ulcer healing research was reviewed by 25 experts over 2 days on September 28 and 29, 2015. Multiple clinical effectiveness reviews were presented suggesting that published clinical wound healing research often does not meet present (2015) evidence based standards. Specific areas requiring remediation were highlighted and approaches to overcoming existing challenges were proposed. Participants using anonymous voting technology developed an action plan to resolve perceived deficiencies. Statements were accepted if 75% of participants agreed. Older patients with a high frequency of comorbid conditions posed particular difficulties in designing clinical research protocols and better diagnostic categorization is necessary A standardized model template for collecting information about diagnosis and evaluation of the effect of interventions on healing of all types of leg ulcers was considered a high priority. Such a model template could be modified depending on the specific etiology of the leg ulcers. Generally agreed on quantifiable standards to establish degree of morbidity was considered a high priority. There was universal agreement that sources of funding and conflicts of interest needed to be disclosed in presentations and all publications. All clinical research studies should be registered with appropriate authorities. There was substantial enthusiasm for a clinical research network with quality standards for membership and an advisory research core available to investigators. Such a network should be funded and actively managed to insure long-term viability. The governance of such an entity needs to be established by the wound care community. The present trend to integrate patients into the clinical research process was endorsed and there was enthusiasm to develop patient advocacy for wound healing research. [ABSTRACT FROM AUTHOR]

Diabetes is the major risk factor for nontraumatic lower extremity amputation (LEA). The role of genetic polymorphisms in predisposing diabetics to impaired wound healing leading to LEA has not been sufficiently explored. We investigated the association between a set of genes belonging to the angiogenesis/wound repair pathway with LEA in the Chronic Renal Insufficiency Cohort, a study of adults with chronic kidney disease (CKD) that includes a subgroup with diabetes. This study was performed on 3,772 Chronic Renal Insufficiency Cohort participants who were genotyped on the ITMAT-Broad-CARe array chip. A total of 1,017 single-nucleotide polymorphisms (SNPs) in 22 genes belonging to the angiogenesis/would repair pathway were investigated. LEA was determined from patient self-report. The association between genetic variants and LEA status was examined using logistic regression and additive genetic models after stratifying the cohort by race/ethnicity and diabetic status. Unadjusted analyses as well as analyses adjusted for age, sex, estimated glomerular filtration rate, body mass index, peripheral vascular disease, hemoglobin A1c, and population stratification were performed. In non-Hispanic white participants with diabetes, rs11938826 and rs1960669, both intronic SNPs in the gene basic fibroblast growth factor-2 (FGF2), were significantly associated with LEA in covariate-adjusted analysis (OR: 2.83 (95% CI: 1.73, 4.62); p-value: 0.000034; Bonferroni adjusted p-value: 0.0006) and (OR: 2.61 (95% CI: 1.48, 4.61); p-value: 0.00095; Bonferroni adjusted p-value: 0.02). In the same subgroup, rs10883688, an FGF8 SNP of unknown functional effect, was also associated with LEA (OR: 1.72 (95% Confidence Interval: 1.14, 2.6); p-value: 0.00999; Bonferroni adjusted p-value: 0.04). No statistically significant associations were identified in the other ethnic groups. In conclusion, variant/s in FGF2 and FGF8 may predispose diabetics with CKD to LEA. Dysregulation of the FGF2 gene represents an opportunity to understand further, and possibly intervene upon, mechanisms of wound healing in diabetics with CKD. [ABSTRACT FROM AUTHOR]

Diabetic foot ulcers (DFUs) affect 1.5 million Americans annually, of which only a minority heal with standard care, and they commonly lead to amputation. To improve care, investigations are underway to better understand DFU pathogenesis and develop more effective therapies. Some currently used medications may improve healing. One small, randomized clinical trial found statins improve DFU healing. In this secondary analysis of a large multisite prospective observational cohort of 139 patients with DFUs receiving standard care, we investigated whether there was an association between 6-week DFU wound size reduction and use of a variety of medications including alpha-blockers, beta-blockers, angiotensin converting enzyme inhibitors (ACEi) and statins. We found no significant ( p < 0.05) association between six-week wound reduction and use of any of the evaluated drugs; however, statins did trend toward an association ( p = 0.057). This suggests a potential benefit of statins on DFU healing, and larger, targeted studies are warranted. [ABSTRACT FROM AUTHOR]

Lower extremity amputation ( LEA) is a life-altering complication of diabetes. The goal of our study was to investigate the possibility that genetic variation in neuronal nitric oxide synthase associated protein ( NOS1AP ) is associated with LEA and diabetic peripheral neuropathy ( DPN). Our work used data from the Chronic Renal Insufficiency Cohort ( CRIC) study. CRIC is a multicenter investigation undertaken to pursue the relationship between chronic renal insufficiency and cardiovascular disease. We evaluated 3,040 CRIC study subjects; 1,490 individuals were African Americans and 1,550 were whites. LEA occurred in 162 (5.3%) subjects, 93 (6.2%) of African Americans and 69 (4.4%) of whites. In whites, NOS1AP single nucleotide polymorphism rs1963645 was most strongly associated with LEA (1.73 [1.23, 2.44]). In African Americans three NOS1AP single nucleotide polymorphisms were associated with LEA: rs6659759 (1.65 [1.21, 2.24]); rs16849113 (1.58 [1.16, 2.14]); rs880296 (1.54 [1.14, 2.10]). We tested a subset of 100 CRIC participants for DPN using Semmes- Weinstein filaments. DPN in those with diabetes was associated with rs1963645 (16.97 [2.38, 120.97]) in whites and rs16849113 and rs6659759 (3.62 [1.11, 11.83] and 3.02 [0.82, 11.12], respectively) in African Americans. In conclusion, this is one of the first studies to show that NOS1AP gene variants are associated with DPN and LEA. [ABSTRACT FROM AUTHOR]

Diabetic patients undergoing hyperbaric oxygen therapies (HBOT) for refractory lower extremity neuropathic ulcers exhibit more than a twofold elevation ( p=0.004) in circulating stem cells after treatments and the post-HBOT CD34 cell population contains two- to threefold higher levels of hypoxia inducible factors-1, -2, and -3, as well as thioredoxin-1 ( p<0.003), than cells present in blood before HBOT. Skin margins obtained from 2-day-old abdominal wounds exhibit higher expression of CD133, CD34, hypoxia inducible factor-1, and Trx-1 vs. margins from refractory lower extremity wounds and expression of these proteins in all wounds is increased due to HBOT ( p<0.003). HBOT is known to mobilize bone marrow stem cells by stimulating nitric oxide synthase. We found that nitric oxide synthase activity is acutely increased in patients' platelets following HBOT and remains elevated for at least 20 hours. We conclude that HBOT stimulates vasculogenic stem cell mobilization from bone marrow of diabetics and more cells are recruited to skin wounds. [ABSTRACT FROM AUTHOR]

Diabetic foot ulcers (DFU) or lower extremity amputation (LEA) are complications of diabetes. In those with diabetes, angiotensin-converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB) are commonly used to prevent the progression of kidney disease. Recent studies have indicated that angiotensin may affect angiogenesis and wound repair. Our goal was to evaluate in those with diabetes the likelihood of developing a DFU or LEA among users of ACEi or ARB using a retrospective cohort design of general practices in the United Kingdom. We studied 40,342 individuals at least 35 years of age with diabetes who were first prescribed ACEi or ARB between 1995 and 2006. A total of 35,153 individuals were treated with ACEi, 12,437 individuals with ARB, and 7,310 both. The hazard ratio for DFU was 0.50 (95% confidence intervals: 0.43, 0.59), showing an increased risk of DFU for those using ACEi vs. ARB. The hazard ratio for LEA was 0.72 (0.48, 1.01). However, among those with lower extremity peripheral arterial disease the hazard ratio was 0.45 (0.22, 0.91) for the new onset of a LEA. In conclusion, among those with diabetes, exposure to ACEi as compared with ARB increases the risk of developing a DFU or LEA. [ABSTRACT FROM AUTHOR]

Our objective was to create a practical standardized database of clinically relevant variables in the care of patients with diabetes and foot ulcers. Numerical clinical variables such as age, baseline laboratory values, and wound area were extracted from the wound electronic medical record (WEMR). A coding system was developed to translate narrative data, culture, and pathology reports into discrete, quantifiable variables. Using data extracted from the WEMR, a diabetic foot ulcer-specific database incorporated the following tables: (1) demographics, medical history, and baseline laboratory values; (2) vascular testing data; (3) radiology data; (4) wound characteristics; and (5) wound debridement data including pathology, culture results, and amputation data. The database contains variables that can be easily exported for analysis. Amputation was studied in 146 patients who had at least two visits (e.g., two entries in the database). Analysis revealed that 19 (13%) patients underwent 32 amputations (nine major and 23 minor) in 23 limbs. There was a decreased risk of amputation, 0.87 (0.78, 1.00), using a proportional hazards model, associated with an increased number of visits and entries in the WEMR. Further analysis revealed no significant difference in age, gender, HbA1c%, cholesterol, white blood cell count, or prealbumin at baseline, whereas hemoglobin and albumin were significantly lower in the amputee group ( p<0.05) than the nonamputee group. Fifty-nine percent of amputees had histological osteomyelitis based on operating room biopsy vs. 45% of nonamputees. In conclusion, tracking patients with a WEMR is a tool that could potentially increase patient safety and quality of care, allowing clinicians to more easily identify a nonhealing wound and intervene. This report describes a method of capturing data relevant to clinical care of a patient with a diabetic foot ulcer, and may enable clinicians to adapt such a system to their own patient population. [ABSTRACT FROM AUTHOR]

This is a randomized factorial design clinical trial that investigates the efficacy and feasibility of providing prognostic information on wound healing. Prognostic information was provided based on baseline or 4-week wound characteristics. Healing rates were then determined at 24 weeks for venous leg ulcers and 20 weeks for diabetic neuropathic foot ulcers. Centers that had access to baseline information for venous leg ulcer prognosis had an odds ratio (OR) of healing of 1.42 (95% confidence interval [CI]: 1.03, 1.95) while centers that had access to information at 4 weeks had an OR of healing of 1.43 (95% CI: 1.05, 1.95) compared with controls. Diabetic neuropathic foot ulcer patients treated in centers that had been randomized to receive only 4-week prognostic information were more likely to heal than individuals seen in centers randomized to receive no intervention (OR 1.50, 95% CI: 1.05, 2.14). Our study found that it is feasible and efficacious to provide prognostic information on venous leg ulcers and diabetic neuropathic foot ulcers in a wound care setting using an existing administrative database. This intervention was easy to administer and likely had low associated costs. This method of dispersing prognostic information to healthcare providers should be expanded to include recently published treatment algorithms. [ABSTRACT FROM AUTHOR]

The purpose of this study was to evaluate the validity of digital photographs for the assessment of the presence of pressure ulcers stage 2 or higher. Participants were 48 patients (28 white and 20 black) with pressure ulcers identified in the course of a wound specialist's routine clinical practice at the University of Maryland Medical Center. One pressure ulcer and one unaffected skin area were photographed on each participating patient. The gold standard diagnosis (stage 2 pressure ulcer vs. stage 1 or no pressure ulcer) was recorded by the wound specialist based on bedside examination. The photographs were reviewed blindly by another wound expert. The sensitivity of the blinded assessment was 97% (95% confidence interval [CI] 91–100%). The specificity was 97% (95% CI 92–100%). The sensitivity and specificity were both 100% in the white patients. In black patients, the sensitivity and specificity were 92% (95% CI 75–100%) and 93% (95% CI 82–100%), respectively. These results suggest that the use of photographic images to assess the presence or absence of a pressure ulcer stage 2 or higher has a high degree of validity. Since blinded outcome assessment is one of the cornerstones of good clinical trial design, photography offers the potential to strengthen future studies. [ABSTRACT FROM AUTHOR]

The article offers suggestions for the prevention of venous ulcers. Compression stockings are suggested for patients with signs of increased ambulatory venous hypertension and postphlebitic syndrome. Exercise to increase calf muscle pump function is stated to be helpful in long-term maintenance and venous ulcer prevention. It is stated that surgery on the venous system such as venous ablation, endovenous laser ablation, and valvuloplasty can help decrease venous hypertension.

The article presents the guidelines in treating patients with venous ulcers of the lower extremities. These are the developers of the guidelines including academicians, podiatrists, private practice physicians, nurse clinicians, research nurses, industrial scientists and an epidemiologist. The guidelines have been developed in eight categories including diagnosis, compression, infection control, wound bed preparation, dressings, surgery, adjuvant agents and long-term maintenance.

To evaluate the ability of research nurses to identify pressure ulcers, the authors assembled digital photographs of the skin of 160 consenting elderly patients (80% African American, 63% women). The series included 39 photos of pressure ulcers, 109 of normal skin, and 12 of other skin conditions, determined by consensus by two experts (D.J.M. and S.H.K.). Photos were packaged electronically into eight blocks of 20, with pressure ulcer prevalence ranging from 20% to 30% per block. The eight blocks were duplicated to create two sets of 160 photos each. Each of six raters (experienced clinical research nurses), working independently, evaluated the 320 photos as if each photo depicted a different patient. For analysis, the ratings were collapsed into binary determinations (any pressure ulcer vs. none). The overall sensitivity and specificity of the ratings were 0.97 (95% confidence interval: 0.94, 0.98) and 0.81 (95% confidence interval: 0.77, 0.86), respectively. Rater-specific prevalence (range: 31.8–47.5%) exceeded the true prevalence (24.4%). Inter- and intrarater reliability coefficients were 0.69 and 0.84, respectively. Trained research nurses can accurately classify pressure ulcers from photographs, even when patients are largely non-White and the photographs depict pressure ulcers spanning all pressure ulcer stages. [ABSTRACT FROM AUTHOR]

The objective of this study was to undertake a retrospective analysis of claims data of diabetic foot ulcer (DFU) patients to determine the rates of amputation and identify the risk and protective factors. Rates of amputation were calculated in patients diagnosed with DFU in the MEDSTAT Marketscan database between January 2000 and December 2002, who had prediagnosis coverage of 90 days. A nested case–control study was conducted using a 1 : 10 ratio of amputee cases to randomly selected nonamputee controls matched on follow-up days. The association of co-morbid conditions, demographic factors, and severity (5+ outpatient claims for DFU) on amputation was estimated by adjusted odds ratios (AOR) with 95% confidence intervals (CIs). The 5911 eligible patients yielded an incidence density rate of 2.30 amputations per 100 person years (95% CI = 1.91, 2.77). The 116 cases and 1153 controls averaged 307.3 and 308.5 observation days, respectively. Amputation was significantly increased by male gender (AOR 1.98), Charlson co-morbidity scores of 4–5 and 6+ (AOR = 2.89 and 5.36, respectively), renal disease (AOR = 2.11), peripheral vascular disease (AOR = 2.67), and 5+ outpatient DFU services (AOR = 2.17). Practitioners may consider more aggressive care and earlier referral to specialists for DFU patients who fit risk profiles for amputation, which include peripheral vascular disease, multiple co-morbid conditions, and repeated outpatient DFU services. [ABSTRACT FROM AUTHOR]

The goal of this study was to estimate the effectiveness in actual clinical practice of recombinant human platelet-derived growth factor (rhPDGF) for the treatment of diabetic neuropathic foot ulcer (DNFU). Previously published pivotal trials have shown that by the 20th week of care 35 percent more ulcers healed in the group randomized to receive rhPDGF than those who did not receive rhPDGF (i.e., a relative risk [RR] of about 1.35). This represents an estimate of the efficacy of rhPDGF under the tightly controlled conditions of randomized clinical trials. Treatment effectiveness under standard clinical practice was estimated in a retrospective cohort study, controlling for treatment selection bias using propensity scores. We noted 24,898 individuals with a DNFU, of whom 9.6 percent received rhPDGF. We successfully created a propensity score model that evenly balanced many wound characteristics between those who received rhPDGF and those who did not. We created five groups, which varied from those least likely to receive rhPDGF to those most likely to receive rhPDGF. The RR, controlling for the propensity, to receive rhPDGF for a healed wound after treatment with rhPDGF as compared with standard care was 1.32 (1.22, 1.38). With respect to amputation, the RR for undergoing amputation after receiving rhPDGF was 0.65 (0.54, 0.78) as compared with those who did not receive rhPDGF. Within the limitations of our study, rhPDGF is more effective than standard therapy in both helping a wound to heal and preventing amputation, and its effect is similar to the efficacy estimates from previously published randomized controlled trials. [ABSTRACT FROM AUTHOR]

A neuropathic foot ulcer is a severe complication of diabetes that can result in a more severe complication, a lower extremity amputation. We conducted a cohort study of 24,616 individuals with a diabetic neuropathic foot ulcer treated within a multicenter wound care network. A total of 1653 (6.7%) individuals had an amputation and 46.3% of these amputations were of a toe or ray (minor amputation). In the more than 10-year follow-up period that we studied, the percentage of those who had an amputation varied between 5.6% and 8.4%. Of those who had an amputation, the percentage that had a minor amputation increased over time from 4.0% in the earliest years to more than 60% in the later years of observation. The single most important determinant of amputation was the observation of fascia, tendon, and bone at the initial assessment. In conclusion, about 7% of those with a diabetic neuropathic foot ulcer will have an amputation and in the past 10 years there has been a remarkable increase in the number of minor as compared to major amputations. [ABSTRACT FROM AUTHOR]

Venous leg ulcers are among the most common chronic wounds. Treatment is commonly with a limb compression bandage. Previous small, often single-center, studies have shown that it is possible to predict which wounds are likely to respond to compression therapy. We designed this cohort study using a dataset of over 20,000 individuals with a venous leg ulcer to investigate the accuracy of several prognostic models. Creating complex models using logistic regression, as well as simply counting prognostic factors, we show that initial measures of wound size and duration accurately predict, as measured by area under the receiver operator curve and Brier score, who will heal by the 24th week of care. For example, a wound that is less than 10 cm2 and less than 12 months old at the first visit has a 29 percent chance of not healing by the 24th week of care, while a wound greater than 10 cm2 and greater than 12 months old has a 78 percent chance of not healing. Ultimately, these models can be applied by a clinician to help determine whom to continue to treat with standard care and perhaps whom to treat with adjuvant therapies. They may also aid in the design of clinical trials. [ABSTRACT FROM AUTHOR]

Most patients with chronic wounds fail to heal in a reasonable period of time. Despite considerable advances in elucidating the molecular basis of wound repair, attempts at developing new therapies have been disappointing. In fact, in the few studies where cytokine growth factors have been efficacious, their effect has been dramatically less than would have been predicted from animal studies. We hypothesize that platelet-derived growth factor-BB, a growth factor associated with wound healing, when produced in large quantities within the wound bed due to adenovirus mediated gene overexpression by the cells of the wound bed will dramatically enhance wound healing. Simply stated, we plan to insure the delivery of the growth factor by using gene therapy techniques so that cells locally involved in the wound healing process will temporarily increase their production of platelet-derived growth factor-BB. We present the first step in the series of human investigations to test this hypothesis which is a phase I clinical trial. Our proposed study is designed to assess local and systemic toxicity, and the feasibility of using the maximum tolerated dose of H5.020CMV.PDGF-b associated with in vivo platelet-derived growth factor-BB gene transduction via an intraulcer injection of H5.020CMV.PDGF-b in patients with a diabetic insensate foot ulcer. [ABSTRACT FROM AUTHOR]

Few epidemiologic studies have examined the effect of clinical risk factors on the probability that a patient with a chronic wound will heal or develop another wound. Curative Health Services maintains one of the few databases that contain detailed patient record information on patients with chronic wounds. The purpose of this study was to evaluate the reliability and validity of using this database to study individuals with diabetic neuropathic foot ulcers. 154 patient medical records were randomly selected from the database and abstracted using a standardized questionnaire and protocol. We assessed three key variables: diagnosis of diabetic neuropathic foot ulcer, whether the patient healed, and if the patient received an autologous product called platelet releasate. These variables in the database very accurately agreed with the information in the patient medical records, with positive predictive values of 98% (95% confidence interval [0.89, 0.99]), 93% (95% confidence interval [0.68, 0.99]), and 100%, respectively. We have shown that, with respect to these three variables, the database is very accurate when compared to the medical record. It therefore represents a valuable tool with which to study patients with diabetic insensate foot ulcers. [ABSTRACT FROM AUTHOR]

ABSTRACT The adherence by patients to diabetic foot ulcer therapy is often difficult. The goal of this study was to begin to understand how a patient's health literacy affects their foot ulcer management decisions. Initially using a cross-sectional study design, we evaluated diabetics with foot ulcers within 4 weeks of being asked to participate in a longitudinal study. We assessed health literacy using measures of general health literacy, diabetes health literacy, diabetes self-efficacy, and diabetes numeracy. Individuals enrolled in the study had higher health literacy based on the Short Test of Functional Health Literacy in Adults [33.8 (SD 2.3) versus 27.3 (SD 9.6); p = 0.009] as compared to individuals who previously declined an invitation to enroll in the study. Furthermore, patients with lower Short Test of Functional Health Literacy in Adults scores had larger ( p = 0.04) and older ( p = 0.125) wounds (markers for poorer prognosis). Other measures of literacy showed similar results. In conclusion, those with diminished health literacy were less likely to enroll in an investigational study and had wounds that were less likely to heal. [ABSTRACT FROM AUTHOR]

The article discusses a study which investigated endothelial progenitor cell (EPC) mobilization following wound injury. Blood samples were taken from subjects that were enrolled from the dermatologic surgical practice at the University of Pennsylvania (UPenn). The researchers found that a change occurred in the peripheral EPC pool within a 1- to 2-hour time frame.