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result(s) for
"Ulcer - therapy"
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A Randomized Trial of Early Endovenous Ablation in Venous Ulceration
by
Bradbury, Andrew
,
Bulbulia, Richard
,
Renton, Sophie
in
Ablation
,
Ablation Techniques - adverse effects
,
Ablation Techniques - methods
2018
In a randomized trial, 450 patients with venous leg ulcers were assigned to early endovenous ablation within 2 weeks after randomization or to deferred ablation after ulcer healing. The time to ulcer healing was shorter with early ablation than with deferred ablation.
Journal Article
Chronic Wounds: Evaluation and Management
2020
Chronic wounds are those that do not progress through a normal, orderly, and timely sequence of repair. They are common and are often incorrectly treated. The morbidity and associated costs of chronic wounds highlight the need to implement wound prevention and treatment guidelines. Common lower extremity wounds include arterial, diabetic, pressure, and venous ulcers. Physical examination alone can often guide the diagnosis. All patients with a nonhealing lower extremity ulcer should have a vascular assessment, including documentation of wound location, size, depth, drainage, and tissue type; palpation of pedal pulses; and measurement of the ankle-brachial index. Atypical nonhealing wounds should be biopsied. The mainstay of treatment is the TIME principle: tissue debridement, infection control, moisture balance, and edges of the wound. After these general measures have been addressed, treatment is specific to the ulcer type. Patients with arterial ulcers should be immediately referred to a vascular surgeon for appropriate intervention. Treatment of venous ulcers involves compression and elevation of the lower extremities, plus exercise if tolerated. Diabetic foot ulcers are managed by offloading the foot and, if necessary, treating the underlying peripheral arterial disease. Pressure ulcers are managed by offloading the affected area.
Journal Article
Urban-Rural Disparities and Temporal Trends in Peptic Ulcer Disease Epidemiology, Treatment, and Outcomes in the United States
2021
The incidence of peptic ulcer disease (PUD) has been decreasing over time with Helicobacter pylori eradication and use of acid-suppressing therapies. However, PUD remains a common cause of hospitalization in the United States. We aimed to evaluate contemporary national trends in the incidence, treatment patterns, and outcomes for PUD-related hospitalizations and compare care delivery by hospital rurality.
Data from the National Inpatient Sample were used to estimate weighted annual rates of PUD-related hospitalizations. Temporal trends were evaluated by joinpoint regression and expressed as annual percent change with 95% confidence intervals (CIs). We determined the proportion of hospitalizations requiring endoscopic and surgical interventions, stratified by clinical presentation and rurality. Multivariable logistic regression was used to assess independent predictors of in-hospital mortality and postoperative morbidity.
There was a 25.8% reduction (P < 0.001) in PUD-related hospitalizations from 2005 to 2014, although the rate of decline decreased from -7.2% per year (95% CI: 13.2% to -0.7%) before 2008 to -2.1% per year (95% CI: 3.0% to -1.1%) after 2008. In-hospital mortality was 2.4% (95% CI: 2.4%-2.5%). Upper endoscopy (84.3% vs 78.4%, P < 0.001) and endoscopic hemostasis (26.1% vs 16.8%, P < 0.001) were more likely to be performed in urban hospitals, whereas surgery was performed less frequently (9.7% vs 10.5%, P < 0.001). In multivariable logistic regression, patients managed in urban hospitals were at higher risk for postoperative morbidity (odds ratio 1.16 [95% CI: 1.04-1.29]), but not death (odds ratio 1.11 [95% CI: 1.00-1.23]).
The rate of decline in hospitalization rates for PUD has stabilized over time, although there remains significant heterogeneity in treatment patterns by hospital rurality.
Journal Article
Clinical efficacy of therapeutic footwear with a rigid rocker sole in the prevention of recurrence in patients with diabetes mellitus and diabetic polineuropathy: A randomized clinical trial
by
López-Moral, Mateo
,
Lázaro-Martínez, José Luis
,
Molines-Barroso, Raúl J.
in
Adolescent
,
Adult
,
Aged
2019
Therapeutic footwear becomes the first treatment line in the prevention of diabetic foot ulcer and future complications of diabetes. Previous studies and the International Working Group on the Diabetic Foot have described therapeutic footwear as a protective factor to reduce the risk of re-ulceration. In this study, we aimed to analyze the efficacy of a rigid rocker sole to reduce the recurrence rate of plantar ulcers in patients with diabetic foot.
Between June 2016 and December 2017, we conducted a randomized controlled trial in a specialized diabetic foot unit.
Fifty-one patients with diabetic neuropathy who had a recently healed plantar ulcer were randomized consecutively into the following two groups: therapeutic footwear with semi-rigid sole (control) or therapeutic footwear with a rigid rocker sole (experimental). All patients included in the study were followed up for 6 months (one visit each 30 ± 2 days) or until the development of a recurrence event.
Primary outcome measure was recurrence of ulcers in the plantar aspect of the foot.
A total of 51 patients were randomized to the control and experimental groups. The median follow-up time was 26 [IQR-4.4-26.1] weeks for both groups. On an intention-to-treat basis, 16 (64%) and 6 (23%) patients in the control and experimental groups had ulcer recurrence, respectively. Among the group with >60% adherence to therapeutic footwear, multivariate analysis showed that the rigid rocker sole improved ulcer recurrence-free survival time in diabetes patients with polyneuropathy and DFU history (P = 0.019; 95% confidence interval, 0.086-0.807; hazard ratio, 0.263).
We recommend the use of therapeutic footwear with a rigid rocker sole in patients with diabetes with polyneuropathy and history of diabetic foot ulcer to reduce the risk of plantar ulcer recurrence.
ClinicalTrials.gov NCT02995863.
Journal Article
Ulcer Bleeding in the United States: Epidemiology, Treatment Success, and Resource Utilization
2024
Background and GoalsPeptic ulcer disease is the most frequent cause of upper gastrointestinal bleeding. We sought to establish the epidemiology and hemostasis success rate of the different treatment modalities in this setting.MethodsRetrospective cohort study using the National Inpatient Sample. Non-elective adult admissions with a principal diagnosis of ulcer bleeding were included. The primary outcome was endoscopic, radiologic and surgical hemostasis success rate. Secondary outcomes were patients’ demographics, in-hospital mortality and resource utilization. On subgroup analysis, gastric and duodenal ulcers were studied separately. Confounders were adjusted for using multivariate regression analysis.ResultsA total of 136,425 admissions (55% gastric and 45% duodenal ulcers) were included. The mean patient age was 67 years. The majority of patients were males, Caucasians, of lower income and high comorbidity burden. The endoscopic, radiological and surgical therapy and hemostasis success rates were 33.6, 1.4, 0.1, and 95.1%, 89.1 and 66.7%, respectively. The in-hospital mortality rate was 1.9% overall, but 2.4% after successful and 11.1% after failed endoscopic hemostasis, respectively. Duodenal ulcers were associated with lower adjusted odds of successful endoscopic hemostasis, but higher odds of early and multiple endoscopies, endoscopic therapy, overall and successful radiological therapy, in-hospital mortality, longer length of stay and higher total hospitalization charges and costs.ConclusionsThe ulcer bleeding endoscopic hemostasis success rate is 95.1%. Rescue therapy is associated with lower hemostasis success and more than a ten-fold increase in mortality rate. Duodenal ulcers are associated with worse treatment outcomes and higher resource utilization compared with gastric ulcers.
Journal Article
Low dose aspirin as adjuvant treatment for venous leg ulceration: pragmatic, randomised, double blind, placebo controlled trial (Aspirin4VLU)
by
Jull, Andrew
,
Bullen, Chris
,
Wadham, Angela
in
Adjuvant therapy
,
Adjuvants, Pharmaceutic
,
Adult
2017
Objective To determine the effect of low dose aspirin on ulcer healing in patients with venous leg ulcers.Design Pragmatic, community based, parallel group, double blind, randomised controlled trial.Setting Five community nursing centres in New Zealand.Participants 251 adults with venous leg ulcers who could safely be treated with aspirin or placebo: 125 were randomised to aspirin and 126 to placebo.Interventions 150 mg oral aspirin daily or matching placebo for up to 24 weeks treatment, with compression therapy as standard background treatment.Main outcome measures The primary outcome was time to complete healing of the reference ulcer (largest ulcer if more than one ulcer was present). Secondary outcomes included proportion of participants healed, change in ulcer area, change in health related quality of life, and adverse events. Analysis was by intention to treat.Results The median number of days to healing of the reference ulcer was 77 in the aspirin group and 69 in the placebo group (hazard ratio 0.85, 95% confidence interval 0.64 to 1.13, P=0.25). The number of participants healed at the endpoint was 88 (70%) in the aspirin group and 101 (80%) in the placebo group (risk difference −9.8%, 95% confidence interval −20.4% to 0.9%, P=0.07). Estimated change in ulcer area was 4.1 cm2 in the aspirin group and 4.8 cm2 in the placebo group (mean difference −0.7 cm2, 95% confidence interval −1.9 to 0.5 cm2, P=0.25). 40 adverse events occurred among 29 participants in the aspirin group and 37 adverse events among 27 participants in the placebo group (incidence rate ratio 1.1, 95% confidence interval 0.7 to 1.7, P=0.71).Conclusion Our findings do not support the use of low dose aspirin as adjuvant treatment for venous leg ulcers.Trial registration ClinicalTrials.gov NCT02158806.
Journal Article
Prevention, Diagnosis, and Management of Chronic Wounds in Older Adults
by
Hoversten, Katherine P.
,
Stolp, Anne M.
,
Verdoorn, Brandon P.
in
Aged
,
Amino acids
,
Care and treatment
2020
Chronic wounds are common, disproportionately affect older adults, and are likely to be encountered by providers across all specialties and care settings. All providers should be familiar with basic wound prevention, identification, classification, and treatment approach, all of which are outlined in this article.
Journal Article
Clinical and cost-effectiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): a randomised controlled trial
2014
Drawbacks exist with the standard treatment (four-layer compression bandages) for venous leg ulcers. We have therefore compared the clinical effectiveness and cost-effectiveness of two-layer compression hosiery with the four-layer bandage for the treatment of such ulcers.
We undertook this pragmatic, open, randomised controlled trial with two parallel groups in 34 centres in England and Northern Ireland. The centres were community nurse teams or services, family doctor practices, leg ulcer clinics, tissue viability clinics or services, and wound clinics. Participants were aged 18 years or older with a venous leg ulcer and an ankle brachial pressure index of at least 0·8, and were tolerant of high compression. We randomly allocated participants (1:1) to receive two-layer compression hosiery or a four-layer bandage, using a remote randomisation service and prevalidated computer randomisation program. Participants were stratified by ulcer duration and ulcer area with permuted blocks (block sizes four and six). The primary endpoint was time to ulcer healing, with a maximum follow-up of 12 months. Although participants and health-care providers were not masked to treatment allocation, the primary endpoint was measured by masked assessment of photographs. Primary analysis was intention to treat with Cox regression, with adjustment for ulcer area, ulcer duration, physical mobility, and centre. This trial is registered with the ISRCTN register, number ISRCTN49373072.
We randomly allocated 457 participants to the two treatment groups: 230 to two-layer hosiery and 227 to the four-layer bandage, of whom 453 (230 hosiery and 223 bandage) contributed data for analysis. Median time to ulcer healing was 99 days (95% CI 84–126) in the hosiery group and 98 days (85–112) in the bandage group, and the proportion of ulcers healing was much the same in the two groups (70·9% hosiery and 70·4% bandage). More hosiery participants changed their allocated treatment (38·3% hosiery vs 27·0% bandage; p=0·02). 300 participants had 895 adverse events, of which 85 (9·5%) were classed as serious but unrelated to trial treatment.
Two-layer compression hosiery is a viable alternative to the four-layer bandage—it is equally as effective at healing venous leg ulcers. However, a higher rate of treatment changes in participants in the hosiery group than in the bandage group suggests that hosiery might not be suitable for all patients.
NIHR Health Technology Assessment programme (07/60/26).
Journal Article
Efficacy and safety of proton pump inhibitors for stress ulcer prophylaxis in critically ill patients: a systematic review and meta-analysis of randomized trials
by
Guyatt, Gordon
,
Lewis, Kim
,
Alshamsi, Fayez
in
Critical Care Medicine
,
Critically ill
,
Duodenal Ulcer - complications
2016
Background
The relative efficacy and safety of proton pump inhibitors (PPIs) compared to histamine-2-receptor antagonists (H2RAs) should guide their use in reducing bleeding risk in the critically ill.
Methods
We searched the Cochrane library, MEDLINE, EMBASE, ACPJC, clinical trials registries, and conference proceedings through November 2015 without language or publication date restrictions. Only randomized controlled trials (RCTs) of PPIs vs H2RAs for stress ulcer prophylaxis in critically ill adults for clinically important bleeding, overt gastrointestinal (GI) bleeding, nosocomial pneumonia, mortality, ICU length of stay and
Clostridium difficile
infection were included. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess our confidence in the evidence for each outcome.
Results
In 19 trials enrolling 2117 patients, PPIs were more effective than H2RAs in reducing the risk of clinically important GI bleeding (RR 0.39; 95 % CI 0.21, 0.71;
P
= 0.002;
I
2
= 0 %, moderate confidence) and overt GI bleeding (RR 0.48; 95 % CI 0.34, 0.66;
P
< 0.0001;
I
2
= 3 %, moderate confidence). PPI use did not significantly affect risk of pneumonia (RR 1.12; 95 % CI 0.86, 1.46;
P
= 0.39;
I
2
= 2 %, low confidence), mortality (RR 1.05; 95 % CI 0.87, 1.27;
P
= 0.61;
I
2
= 0 %, moderate confidence), or ICU length of stay (mean difference (MD), –0.38 days; 95 % CI –1.49, 0.74;
P
= 0.51;
I
2
= 30 %, low confidence). No RCT reported Clostridium difficile infection.
Conclusions
PPIs were superior to H2RAs in preventing clinically important and overt GI bleeding, without significantly increasing the risk of pneumonia or mortality. Their impact on Clostridium difficile infection is yet to be determined.
Journal Article
An extended 36-week oral esomeprazole improved long-term recurrent peptic ulcer bleeding in patients at high risk of rebleeding
by
Yang, Er-Hsiang
,
Wu, Chung-Tai
,
Chen, Wei-Ying
in
Bleeding
,
Causes of
,
Complications and side effects
2022
Background
Patients with Rockall scores ≥6 have an increased risk of long-term peptic ulcer rebleeding. This study was aimed toward investigating whether an extended course of oral esomeprazole up to 1 year decreased ulcer rebleeding in such patients.
Methods
We prospectively enrolled 120 patients with peptic ulcer bleeding and Rockall scores ≥6. After an initial 16-week oral proton pump inhibitor (PPI) treatment, patients were randomized to receive a 36-week course of oral twice-daily esomeprazole 20 mg (Group D,
n
= 60) or once-daily (Group S,
n
= 60). Thereafter, they were divided into the PPI-on-demand (
n
= 32) and PPI-discontinued (
n
= 77) subgroups. Our previous cohort with Rockall scores ≥6 served as the controls (Group C,
n
= 135); they received only an initial 8- to 16-week oral PPI. The primary and secondary outcomes were peptic ulcer rebleeding during the first year and the second year-and-thereafter, respectively.
Results
For the primary outcome, groups D and S comprised a higher proportion of rebleeding-free than Group C (
P
= 0.008 and 0.03, log-rank test). The competing-risks regression analysis confirmed that extended PPI use and American Society of Anesthesiologists classification were independent factors contributing to the primary outcome. For the secondary outcome, PPI-on-demand had a borderline higher proportion of rebleeding-free than Group C (
P
= 0.07, log-rank test); however, only the Rockall score was the independent factor.
Conclusions
An extended 36-week course of oral esomeprazole 20 mg, twice- or once-daily for patients with Rockall scores ≥6 reduced ulcer rebleeding during the first year, but the effect needed to be further validated when PPIs were shifted to on-demand or discontinued thereafter (NCT02456012, 28/05/2015).
Journal Article