Effectiveness of a new brand of stock 'diabetic' shoes to protect against diabetic foot ulcer relapse. A prospective cohort study.

AIMS: Diabetic patients with podopathy (diabetic foot syndrome) may need protective footwear, be it customized or industrially produced stock 'diabetic' shoes (SDS). The effectiveness of each type of 'diabetic' shoe needs to be proven clinically, e.g. in terms of prevention of foot ulceration. The following study assesses a new German SDS, the LucRo shoe, which consists of rocker-shaped walking sole, a standardized shock absorption insole, and soft uppers without stiff toe-caps. The LucRo SDS has been registered as a Medicinal Product according to the European Community Guideline 93/42/EC. PATIENTS AND METHODS: A total of 92 high-risk diabetic patients (mean age 63 years, duration of diabetes 13 years) with healed foot ulcer were recruited prospectively over 31 months; 87 patients suffered from polyneuropathy, 24 patients had peripheral ischaemic vessel disease. One group of patients (n = 60) received the LucRo SDS and wore them, while the remaining patients (n = 32) did not receive the SDS and were forced to use their normal footwear. This allocation reflects the haphazard reimbursement policies of the individual patients' health insurance, and is in accordance with the current German legislation. The patients were followed up for up to 42 months until the first foot ulcer relapse, or the end of the study. RESULTS: There were no differences between the groups concerning age, sex, type and duration of diabetes, prevalence of polyneuropathy and peripheral ischaemic vessel disease, frequency of foot care and mortality rate. The first year annual rate of foot ulcer relapse was significantly different between the groups: 60% without SDS vs. 15% with SDS. The overall cumulative ulcer-free survival was significantly greater with SDS (P < 0.0001, log rank test). CONCLUSION: The LucRo stock 'diabetic' shoe appears effective in the prevention of foot re-ulceration in high-risk patients with diabetic podopathy.     

Risk factors associated with adverse outcomes in a population-based prospective cohort study of people with their first diabetic foot ulcer

AIMS/HYPOTHESIS: The aim of this study was to determine which clinic-based measures of diabetes and foot status at baseline were associated with adverse outcomes 18 months later in people with diabetes presenting with their first foot ulcer. SUBJECTS AND METHODS: This was a prospective population-based cohort study of adults with type 1 and type 2 diabetes mellitus presenting with their first foot ulcer (excluding those with severe ischaemia, ankle brachial pressure index <0.5). The main explanatory variables were age, sex, smoking status, ulcer site (dorsal or plantar), size and severity of ulcer, severity of neuropathy, ischaemia, glycosylated haemoglobin, presence of micro- and macrovascular complications, and depression. The main outcomes recorded were death, amputation and recurrence of ulceration, and the time taken for each outcome to occur. RESULTS: Two hundred fifty-three people were recruited. There were 40 deaths (15.8%), 36 amputations (15.5%), and 99 recurrences (43.2%) at 18 months. Our main findings were that being older [hazard ratio (HR) 1.07, 95% CI 1.04-1.11], having lower glycosylated haemoglobin (HR 0.73, 95% CI 0.56-0.96), moderate ischaemia (HR 2.74, 95% CI 1.46-5.14), and depression (HR 2.51, 95% CI 1.33-4.73) were associated with mortality. Ulcer severity was the only explanatory factor significantly associated with amputation (HR 3.18, 95% CI 1.53-6.59). Microvascular complications were the only explanatory factor associated with recurrent ulceration (HR 3.34, 95% CI 1.17-9.56). CONCLUSIONS/INTERPRETATION: Commonly used primary and secondary care clinic-based measures could provide the basis for a risk assessment tool for adverse outcomes following first presentation of diabetic foot ulcers.     

Prognosis of the infected diabetic foot ulcer: a 12‐month prospective observational study

Aims

To determine clinical outcomes and explore prognostic factors related to ulcer healing in people with a clinically infected diabetic foot ulcer.

Methods

This multicentre, prospective, observational study reviewed participants’ data at 12 months after culture of a diabetic foot ulcer requiring antibiotic therapy. From participants’ notes, we obtained information on the incidence of wound healing, ulcer recurrence, lower extremity amputation, lower extremity revascularization and death. We estimated the cumulative incidence of healing at 6 and 12 months, adjusted for lower extremity amputation and death using a competing risk analysis, and explored the relationship between baseline factors and healing incidence.

Results

In the first year after culture of the index ulcer, 45/299 participants (15.1%) had died. The ulcer had healed in 136 participants (45.5%), but recurred in 13 (9.6%). An ipsilateral lower extremity amputation was recorded in 52 (17.4%) and revascularization surgery in 18 participants (6.0%). Participants with an ulcer present for ~2 months or more had a lower incidence of healing (hazard ratio 0.55, 95% CI 0.39 to 0.77), as did those with a PEDIS (perfusion, extent, depth, infection, sensation) perfusion grade of ≥2 (hazard ratio 0.37, 95% CI 0.25 to 0.55). Participants with a single ulcer on their index foot had a higher incidence of healing than those with multiple ulcers (hazard ratio 1.90, 95% CI 1.18 to 3.06).

Conclusions

Clinical outcomes at 12 months for people with an infected diabetic foot ulcer are generally poor. Our data confirm the adverse prognostic effect of limb ischaemia, longer ulcer duration and the presence of multiple ulcers.     

Prevalence and incidence of peptic ulcer disease in a Danish County--a prospective cohort study.

Peptic ulcer prevalence and five year incidence were assessed in a sex and age stratified population sample of 3608 Danish subjects aged 30-60 years. Statements of peptic ulcer disease obtained from questionnaires were scrutinised by reviewing medical records. Life time ulcer prevalence (95% confidence intervals) was 5.6 (4.9-6.4) per cent. Male to female prevalence ratio was 2.2:1, and duodenal to gastric ulcer prevalence ratio was 3.8:1. Thirty two participants with no previous history of peptic ulceration developed an ulcer within the observation period resulting in a five year ulcer incidence of 11.3 (7.4-15.2) per 1000 persons at risk with no demonstrable sex difference. The prevalence of duodenal ulcer has declined in Denmark whereas gastric ulcer prevalence in men has increased slightly. A decline in male duodenal ulcer incidence has probably contributed to the low male to female ulcer incidence ratio, implying that women today incur the same risk of developing an ulcer as men. If such trends continue, they will bring about a new era in ulcer epidemiology characterised by equal incidence in men and women and an even distribution of lesions in the stomach and duodenum.     

Delivery of care to diabetic patients with foot ulcers in daily practice: results of the Eurodiale Study,a prospective cohort study

Aims To determine current management and to identify patient‐related factors and barriers that influence management strategies in diabetic foot disease. Methods The Eurodiale Study is a prospective cohort study of 1232 consecutive individuals presenting with a new diabetic foot ulcer in 14 centres across Europe. We determined the use of management strategies: referral, use of offloading, vascular imaging and revascularization. Results Twenty‐seven percent of the patients had been treated for > 3 months before referral to a foot clinic. This varied considerably between countries (6–55%). At study entry, 77% of the patients had no or inadequate offloading. During follow‐up, casting was used in 35% (0–68%) of the plantar fore‐ or midfoot ulcers. Predictors of use of casting were male gender, large ulcer size and being employed. Vascular imaging was performed in 56% (14–86%) of patients with severe limb ischaemia; revascularization was performed in 43%. Predictors of use of vascular imaging were the presence of infection and ischaemic rest pain. Conclusion Treatment of many patients is not in line with current guidelines and there are large differences between countries and centres. Our data suggest that current guidelines are too general and that healthcare organizational barriers and personal beliefs result in underuse of recommended therapies. Action should be undertaken to overcome these barriers and to guarantee the delivery of optimal care for the many individuals with diabetic foot disease.     

The risk of foot ulceration in diabetic patients with high foot pressure: a prospective study

Summary Foot ulceration results in substantial morbidity amongst diabetic patients. We have studied prospectively the relationship between high foot pressures and foot ulceration using an optical pedobarograph. A series of 86 diabetic patients, mean age 53.3 (range 17–77) years, mean duration of diabetes 17.1 (range 1–36) years, were followed-up for a mean period of 30 (range 15–34) months. Clinical neuropathy was present in 58 (67%) patients at baseline examination. Mean peak foot pressure was higher at the follow-up compared to baseline (13.5 kg·cm^–2±7.1 SD vs 11.2±5.4, p<0.001) with abnormally high foot pressures (>12.3) being present in 55 patients at follow-up and 43 at the baseline visit (p=NS). Plantar foot ulcers developed in 21 feet of 15 patients (17%), all of whom had abnormally high pressures at baseline; neuropathy was present in 14 patients at baseline. Non-plantar ulcers occurred in 8 (9%) patients. Thus, plantar ulceration occurred in 35% of diabetic patients with high foot pressures but in none of those with normal pressures. We have shown for the first time in a prospective study that high plantar foot pressures in diabetic patients are strongly predictive of subsequent plantar ulceration, especially in the presence of neuropathy.     

Pregnancy-associated plasma protein A in a large cohort of Type 1 diabetic patients with and without diabetic nephropathy-a prospective follow--up study.

AIM: Pregnancy-associated plasma protein A (PAPP-A) has been implicated in the aetiology of acute coronary syndromes and carotid and peripheral artherosclerosis. Diabetic nephropathy is characterized by increased cardiovascular risk. We investigated the prognostic value of PAPP-A in a large cohort of Type 1 diabetic patients. METHODS: In a prospective observational follow-up study, 197 Type 1 diabetic patients with diabetic nephropathy and a matched group of 178 patients with normoalbuminuria were followed for 10.1 (0-10.3) years. PAPP-A was determined at baseline. RESULTS: In patients with diabetic nephropathy, plasma PAPP-A was elevated 3.6 (0.4-51.1) mIU/l [median (range)] vs. 2.1 (0.4-46.6) mIU/l in normoalbuminuric patients, P < 0.0001. For acute coronary syndromes, a PAPP-A threshold of 10 mIU/l has been suggested. Thirty-seven patients were above the threshold and of these 13 patients (35%) died, compared with 60 of 338 patients (18%) below the threshold; log rank test P = 0.007. PAPP-A significantly predicted mortality after adjustment for presence of nephropathy; hazard ratio for dying when PAPP-A was above the threshold 2.1 (95% CI 1.13-3.9); P = 0.019. After adjusting for traditional risk factors, the results were attenuated. When only patients with nephropathy were analysed, PAPP-A was significantly predictive of all-cause mortality [P = 0.008; 2.43 (1.26-4.67)] in unadjusted analysis. After adjustment, the predictive value of PAPP-A for all-cause mortality was attenuated (P = 0.064). CONCLUSION: We find PAPP-A to be associated with increased mortality in Type 1 diabetic patients with nephropathy in unadjusted analysis. After adjustment for traditional risk factors, the prognostic value of PAPP-A was no longer significant.     

Evaluation of a comprehensive diabetic foot ulcer care quality model

AimsDiabetes-related amputations are typically preceded by a diabetic foot ulcer (DFU) but models to assess the quality of care are lacking. We investigated a model to measure inpatient and outpatient quality.MethodsCohort study among adults hospitalized with a DFU to a safety-net hospital during 2016. We measured adherence to DFU-related quality metrics based on guidelines during and 12 months following hospitalization. Inpatient metrics included ankle-brachial index measurement during or 6 months prior to hospitalization, receiving diabetes education and a wound offloading device prior to discharge. Outpatient metrics included wound care ≤30 days of discharge, in addition to hemoglobin A1c (HbA1c) ≤8%, tobacco cessation, and retention in care (≥2 clinic visits ≥90 days apart) 12 months following discharge.Results323 patients were included. Regarding inpatient metrics, 8% had an ankle brachial index measurement, 37% received diabetes education, and 20% received offloading prior to discharge. Regarding outpatient metrics, 33% received wound care ≤30 days of discharge. Twelve months following discharge, 34% achieved a HbA1c ≤8%, 13% quit tobacco, and 52% were retained in care. Twelve-month amputation-free survival was 71%.ConclusionsOur model demonstrated large gaps in DFU guideline-adherent care. Implementing measures to close these gaps could prevent amputations.     

Dietary and metabolomic determinants of relapse in ulcerative colitis patients: A pilot prospective cohort study

AIM To identify demographic, clinical, metabolomic, and lifestyle related predictors of relapse in adult ulcerative colitis(UC) patients.METHODS In this prospective pilot study, UC patients in clinical remission were recruited and followed-up at 12 mo to assess a clinical relapse, or not. At baseline information on demographic and clinical parameters was collected. Serum and urine samples were collected for analysis of metabolomic assays using a combined direct infusion/liquid chromatography tandem mass spectrometry and nuclear magnetic resolution spectroscopy. Stool samples were also collected to measure fecal calprotectin(FCP). Dietary assessment was performed using a validated self-administered food frequency questionnaire. RESULTS Twenty patients were included(mean age: 42.7 ± 14.8 years, females: 55%). Seven patients(35%) experienced a clinical relapse during the follow-up period. While 6 patients(66.7%) with normal body weight developed a clinical relapse, 1 UC patient(9.1%) who was overweight/obese relapsed during the follow-up(P = 0.02). At baseline, poultry intake was significantly higher in patients who were still in remission during follow-up(0.9 oz vs 0.2 oz, P = 0.002). Five patients(71.4%) with FCP 150 μg/g and 2 patients(15.4%) with normal FCP(≤ 150 μg/g) at baseline relapsed during the follow-up(P = 0.02). Interestingly, baseline urinary and serum metabolomic profiling of UC patients with or without clinical relapse within 12 mo showed a significant difference. The most important metabolites that were responsible for this discrimination were trans-aconitate, cystine and acetamide in urine, and 3-hydroxybutyrate, acetoacetate and acetone in serum. CONCLUSION A combination of baseline dietary intake, fecal calprotectin, and metabolomic factors are associated with risk of UC clinical relapse within 12 mo.     

Healing times and prediction of wound healing in neuropathic diabetic foot ulcers: a prospective study.

Time line of wound healing and prediction of healing times in diabetic foot ulcers is an important issue. Usually, the percentage of wounds healed within a defined period is used for characterization of wound healing. R=sqrtA/pi (R, radius; A, planimetric wound area; pi, constant 3.14), and the wound radius reduction was 0.39 mm/week which was previously established. The initial average wound area was 96.9+/-13.1 mm2 (mean+/-SEM), and 3.61+/-1.6 mm 2 after ten weeks with an average healing time of 75.9 (95 %-CI 71-81) days. Using the equation mentioned above and the calculated weekly wound radius reduction, the predicted healing time in the test group was 86.9 (95 %-CI 73-101) days. The predicted and the observed healing times were significantly correlated with each other (r=0.55, p=0.0002). Providing standard care, the time needed for wound healing can reliably be predicted in neuropathic diabetic foot ulcers. This may be a useful tool in daily clinical practice to predict wound healing and recognize ulcers who do not respond adequately to the treatment.     

Effectiveness of DOT for tuberculosis treatment outcomes: a prospective cohort study in Bangkok, Thailand.

SETTING: All health care centres under the Department of Health, Bangkok Metropolitan Administration. OBJECTIVES: To investigate patterns of drug administration for tuberculosis (TB) patients and to determine whether these patterns affect treatment success rates. DESIGN: In a prospective cohort study conducted during May 2004 to November 2005, newly diagnosed TB patients aged >/=15 years were enrolled after giving informed consent. The cohort was followed until treatment outcome. Structured questionnaires were used to interview patients three times: at the first visit, at the end of the intensive phase and at treatment completion. Data were also collected from treatment cards. RESULTS: Five patterns of drug administration were used in the health centres: centre-based directly observed treatment (DOT), family-based DOT, self-administered treatment (SAT), centre-based DOT + SAT and centre- + family-based DOT. The pattern of drug administration had a significant impact on treatment success (P < 0.001). Using unconditional binary multiple logistic regression controlling for confounding factors, centre- + family-based DOT had the highest success rates compared with centre-based DOT (OR 20.9, 95%CI 5.0-88.3). CONCLUSION: The pattern of drug administration impacted on treatment success. Centre- + family-based DOT, family-based DOT and centre-based DOT + SAT achieved higher rates of treatment success than the World Health Organization target. Centre-based DOT had the lowest success.     

Topical application of the bee hive protectant propolis is well tolerated and improves human diabetic foot ulcer healing in a prospective feasibility study

AimsPropolis is a naturally occurring anti-inflammatory bee derived protectant resin. We have previously reported that topically applied propolis reduces inflammation and improves cutaneous ulcer healing in diabetic rodents. The aim of this study was to determine if propolis shows efficacy in a pilot study of human diabetic foot ulcer (DFU) healing and if it is well tolerated.MaterialsSerial consenting subjects (n = 24) with DFU ≥ 4 week's duration had topical propolis applied at each clinic review for 6 weeks. Post-debridement wound fluid was analyzed for viable bacterial count and pro-inflammatory MMP-9 activity. Ulcer healing data were compared with a matched control cohort of n = 84 with comparable DFU treated recently at the same center.ResultsUlcer area was reduced by a mean 41% in the propolis group compared with 16% in the control group at week 1 (P < 0.001), and by 63 vs. 44% at week 3, respectively (P < 0.05). In addition, 10 vs. 2% (P < 0.001), then 19 vs. 12% (P < 0.05) of propolis treated vs. control ulcers had fully healed by weeks 3 and 7, respectively. Post-debridement wound fluid active MMP-9 was significantly reduced, by 18.1 vs. 2.8% week 3 from baseline in propolis treated ulcers vs. controls (P < 0.001), as were bacterial counts (P < 0.001). No adverse effects from propolis were reported.ConclusionsTopical propolis is a well-tolerated therapy for wound healing and this pilot in human DFU indicates for the first time that it may enhance wound closure in this setting when applied weekly. A multi-site randomized controlled of topical propolis now appears to be warranted in diabetic foot ulcers.     

Outcome of diabetic foot infections treated conservatively: a retrospective cohort study with long-term follow-up

BACKGROUND: Diabetic foot lesion is associated with increased morbidity and high resource use. Although early amputation has been advocated in case of osteomyelitis, conservative treatment is a more attractive alternative. OBJECTIVE: To identify criteria predictive of failure of conservative treatment of diabetic foot ulcer at time of admission to the hospital. METHODS: We conducted a 5-year retrospective cohort study with prospective long-term follow-up of all diabetic patients admitted for a foot lesion at a large (1600-bed) teaching institution. Predetermined criteria were used for the diagnosis and classification of diabetic foot lesions (Wagner classification). Study variables included patient demographics and clinical parameters related to infection and diabetes. The average follow-up after hospital discharge was 2 years. Failure of conservative treatment was the main outcome measure. Independent predictor variables were selected by logistic regression analysis. RESULTS: A total of 120 diabetic patients were admitted for foot lesions; complications of contiguous osteomyelitis, deep tissue involvement, and/or gangrenous lesions occurred in 78 (74%) of the 105 patients for whom charts were available. Fourteen patients (13%) underwent immediate amputation. Conservative treatment was successful for 57 (63%) of the 91 remaining patients. Success was achieved in 21 (81%) of 26 patients presenting with skin ulcer, 35 (70%) of 50 patients with deep tissue infection or suspected osteomyelitis, and 1 (7%) of 15 patients with gangrene (P<.001, chi2 for trend). Independent factors predictive of failure were the presence of fever (odds ratio [OR]=1.1 per degrees Celcius; 95% confidence interval [CI], 1.0-1.2) and increased serum creatinine level (OR=1.002 per micromoles per liter; 95% CI, 1.0020-1.0021) on admission, prior hospitalization for diabetic foot lesion (OR=1.4; 95% CI, 1.2-1.6), and gangrenous lesion (OR=1.8; 95% CI, 1.5-2.2). Other patient characteristics, demographics, duration of diabetes mellitus, neutrophil count, or the anatomical site of the lesion failed to predict outcome. CONCLUSIONS: Conservative treatment, including prolonged, culture-guided parenteral and oral antibiotics, is successful without amputation in a large proportion of diabetic patients admitted for a foot skin ulcer or suspected osteomyelitis. Future studies comparing early amputation with novel therapeutic strategies for severe diabetic foot infection should take into account currently identified factors that predicted failure of conservative treatment on admission to the hospital.