Rationale for participation in venous leg ulcer clinical research: Patient interview study.
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ABSTRACT:
SUBMITTER: Weller CD
PROVIDER: S-EPMC7948544 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Venous leg ulcers are a prevalent nonhealing wound of the lower extremity. Although topically applied growth factors successfully improve wound repair in animal studies, similar studies on humans with venous leg ulcers have not been successful. This study was designed to evaluate the acute safety and biologic feasibility of peri-ulcer injection of a replication-incompetent adenoviral construct expressing platelet-derived growth factor-beta (PDGF-beta). In this phase I study, we demonstrate the initial safety, feasibility, and biologic plausibility of using H5.020CMV.PDGF-beta to treat venous leg ulcer disease.
| S-EPMC2835007 | biostudies-literature
Project description:Venous leg ulceration is a common and costly problem that is expected to worsen as the population ages. Current treatment is compression therapy; however, up to 50 % of ulcers remain unhealed after 2 years, and ulcer recurrence is common. New treatments are needed to address those wounds that are more challenging to heal. Targeting the inflammatory processes present in venous ulcers is a possible strategy. Limited evidence suggests that a daily dose of aspirin may be an effective adjunct to aid ulcer healing and reduce recurrence. The Aspirin in Venous Leg Ulcer study (ASPiVLU) will investigate whether 300-mg oral doses of aspirin improve time to healing.This randomised, double-blinded, multicentre, placebo-controlled, clinical trial will recruit participants with venous leg ulcers from community settings and hospital outpatient wound clinics across Australia. Two hundred sixty-eight participants with venous leg ulcers will be randomised to receive either aspirin or placebo, in addition to compression therapy, for 24 weeks. The primary outcome is time to healing within 12 weeks. Secondary outcomes are ulcer recurrence, wound pain, quality of life and wellbeing, adherence to study medication, adherence to compression therapy, serum inflammatory markers, hospitalisations, and adverse events at 24 weeks.The ASPiVLU trial will investigate the efficacy and safety of aspirin as an adjunct to compression therapy to treat venous leg ulcers. Study completion is anticipated to occur in December 2018.Australian New Zealand Clinical Trials Registry, ACTRN12614000293662.
| S-EPMC4827178 | biostudies-literature
Project description:Background and aimsThere is widespread variation in venous leg ulcer (VLU) wound care contributing to inadequate service provision resulting in poor outcomes to patients. Little has been published on the perspectives of where treatments should be carried out. The aim of the study was to quantify respondents' preferences for the preferred place of treatment for VLU.MethodsA UK general population sample was interviewed to elicit preferences for clinic or home care treatment using the willingness to pay elicitation method. Participants were presented with two vignettes describing clinic or home care of VLU, and were asked to select the treatment process that they preferred and provide a detailed explanation for selecting that choice. Then they were asked to state their maximum hypothetical amounts that they were willing to pay for the treatment processes.ResultsOne hundred fifty-four participants completed the interviews. Respondents were willing to pay £498.96 to receive VLU treatment at a clinic and £505.60 to receive care at home. This difference between the clinic compared to home care was not statistically significant. Advantages of clinic care include being able to book an appointment allowing participants to plan events around the booking and for home care the convenience for those with impaired mobility who may have difficulty traveling.ConclusionsThe results show that respondents placed an equal valuation on the place of treatment suggesting no strong preference for either home or clinic care. However, qualitative findings emphasized that impaired mobility may be a barrier to accessing VLU services for some therefore, individuals should be given the choice to select their preferred setting to receive treatment where possible.
| S-EPMC9240381 | biostudies-literature
Project description:Objective: To develop a venous leg ulcer (VLU) risk stratification system for use in research and clinical practice. Approach: U.S. Wound Registry data were examined retrospectively and assigned an outcome. Bivariate analysis identified significant variables (p?<?0.05) that were used to create a multivariable logistic regression model. Ulcers with data for wound area at the first visit before debridement were included in regression analysis, which was based on a 90% development sample. The model was validated on a hold-out 10% data sample. Results: The original dataset included 26,713 VLUs, of which 11,773 ulcers were eligible for preliminary analysis and 10,942 ulcers were eligible for regression analysis. The 90% development model included 9,898 ulcers, of which 7,498 healed (75.8%). The 10% validation sample included 1,044 ulcers, of which 809 healed (77.5%). The following variables significantly predicted healing: number of concurrent wounds of any etiology, wound size, wound age (in days), evidence of bioburden/infection, being nonambulatory, and hospitalization for any reason. Innovation: The VLU Wound Healing Index (WHI) is a comprehensive, validated risk stratification model for predicting VLU healing that incorporates patient- and wound-specific variables. Conclusions: The WHI can identify which VLUs most likely require adjunctive therapies to heal, prioritize referral to venous experts, risk-stratify ulcers to create more generalizable clinical trials and understand the impact of clinical interventions. The Centers for Medicare and Medicaid Services accepts this method for reporting VLU outcome under the Quality Payment Program.
| S-EPMC6940587 | biostudies-literature
Project description:Venous leg ulcers (VLUs) are often refractory to compression therapy, and their prevalence is increasing. An autologous homologous skin construct (AHSC) that uses the endogenous regenerative capacity of healthy skin has been developed to treat cutaneous defects, with a single application. The ability of AHSC to close VLUs with a single treatment was evaluated in an open-label, single-arm feasibility study to test the hypothesis that AHSC treatment will result in wound closure by providing healthy autologous tissue to the wound bed. Methods:Ten VLUs were treated with a single application of AHSC. A 1.5?cm2 full-thickness skin harvest from the proximal calf was collected and sent to a Food and Drug Administration-registered facility, where it was processed into AHSC and returned to the provider within 48 hours. AHSC was spread evenly across the wound and dressed with silicone. The primary endpoint was wound closure rate at 12 weeks. Wound closure was followed with 3-dimensional planimetry, and closure was confirmed by a panel of plastic surgeons. Additional endpoints followed for 12 weeks included graft take, harvest site closure, adverse event rate, complications, and patient-reported pain. Results:All 10 VLUs demonstrated successful graft take as evidenced by graft persisting in wound and harvest site closure. Eight VLUs exhibited complete closure within 12 weeks. One VLU that failed to heal with a prior split thickness skin graft closed within 13.5 weeks with AHSC. The mean time of closure was 34 days (95% confidence interval, 14-53). Pain improved by closure confirmation visit. There was 1 serious adverse event unrelated to the product or procedure. Conclusion:This pilot study demonstrated that AHSC may be a viable single-application topical intervention for VLUs and warrants further investigation in larger, controlled studies.
| S-EPMC7413806 | biostudies-literature
Project description:BACKGROUND:Venous leg ulcers (VLUs), the most common type of leg ulcerations, have long healing times and high recurrence rates; reimbursement rules and a general shortage of nursing staff have put self-treatment into focus. The study aimed to investigate why and how patients with VLUs self-treat their ulcers. METHODS:Patients with VLUs (N = 32) were selected by criterion sampling for a multicentric qualitative study using semi-structured interviews. The interviews were analyzed via inductive qualitative content analysis. RESULTS:More than two-thirds of participants sometimes self-treated VLU and one quarter changed their prescribed treatment. Experiences were expressed through four themes as follows: (a) current local VLU therapy; (b) VLU self-treatment; (c) patient education; and (d) psychosocial issues. The main reasons for self-treatment were a lack of healthcare resources, reimbursement restrictions, and dissatisfaction with conventional treatment together with insufficient knowledge about the wound-healing process and possible side effects. No educational materials were provided for patients or caregivers. Many patients adopted homemade remedies. CONCLUSION:Patients with VLUs practice self-care due to limited healthcare availability, a low awareness of the causes of their condition, and the effects of therapy on VLU healing. Future educational intervention is needed to enhance self-treatment.
| S-EPMC6406886 | biostudies-other
Project description:The aim of this study was to gain a better understanding of the venous leg ulcer (VLU) management in primary health care settings located in Melbourne metropolitan and rural Victoria, Australia. We explored health professionals' perspective on the use of the Australian and New Zealand Venous Leg Ulcer Clinical Practice Guideline (VLU CPG) to identify the main challenges of VLU CPG uptake in clinical practice. We conducted semi-structured interviews with 15 general practitioners (GPs) and 20 practice nurses (PNs), including two Aboriginal health nurses. The Theoretical Domains Framework guided data collection and analysis. Data were analysed using a theory-driven analysis. We found a lack of awareness of the VLU CPGs, which resulted in suboptimal knowledge and limited adherence to evidence-based recommendations. Environmental factors, such as busy nature of clinical environment and absence of handheld Doppler ultrasound, as well as social and professional identity factors, such as reliance on previous experience and colleague's advice, influenced the uptake of the VLU CPGs in primary care. Findings of this study will inform development of interventions to increase the uptake of the VLU CPG in primary care settings and to reduce the evidence-practice gap in VLU management by health professionals.
| S-EPMC7948630 | biostudies-literature
Project description:BACKGROUND:Venous leg ulcers are slow-healing wounds with a high recurrence rate of 70% and a 60% risk of becoming chronic. Signs and symptoms such as pain or exudate are not only a burden on those affected but also on the healthcare system and society in general. The estimated leg ulcer prevalence in the general population is 1%. Treatment costs for leg ulcers are estimated to be 3% of overall health expenditure. Current therapeutic approaches are multifaceted and include compression therapy, leg elevation, specific ankle-exercises and a protein diet. They require an interdisciplinary team of health care professionals. Approximately 70% of patients have a knowledge deficit with regards to therapeutic measures and have difficulties with adherence to treatment protocols. Therefore, it is of utmost importance that the treatment team provides effective patient education and support during the learning phase. However, there is little evidence and no published studies that describe and evaluate effective interdisciplinary educational interventions that target compliance/adherence to the treatment plan in patients with leg ulcers. We therefore propose to develop an evidence-based interprofessional educational intervention and evaluate its feasibility first in a pilot study and subsequently in a randomized controlled trial. METHOD/DESIGN:First, the development of an evidence-based educational intervention in collaboration with an expert panel is proposed and second, a randomized controlled feasibility study in a wound-care outpatient clinic. Eligible patients (n = 20) with leg ulcers will be randomized to receive either interdisciplinary education and usual care or only usual care, for 12?weeks. Data will be analyzed using SPSS version 25. Univariate and bivariate analysis will be conducted according to the data level and distribution of the data. DISCUSSION:We will first develop an evidenced-based educational intervention and second, we will examine the feasibility of implementing this educational intervention in a realistic care context in patients with leg ulcers. The results will inform the final design of a subsequent randomized controlled trial, which will examine the effectiveness of the educational intervention. An intervention that enhances patient adherence to therapy would be beneficial to individual patients and to society as a whole. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03454698 . Registered on 6 March 2018.
| S-EPMC6489295 | biostudies-literature
Project description:IntroductionChronic venous insufficiency (CVI) affects up to one-third of the adult population yet venous leg ulcers (VLU), a significant complication of CVI, only affect 1%-2% of adults in the USA. Why some develop VLU and others do not is unclear. VLU have a significant impact on quality of life and are extremely costly and difficult to treat. Moreover, VLU prevalence is increasing, doubling in the last 20 years. In order to characterise the differences between people with CVI and those who ultimately develop VLU, we aim to set up the unique venous insufficiency in South Florida cohort.Methods and analysisSubjects will be recruited from the University of Miami Hospital and Clinic's vascular laboratory database, which began in July 2011. Any adult age 18-95 who has had venous reflux detected on duplex ultrasound of the lower extremities is included. Approximately 2500 patients are already in the database that meet these criteria, with an estimated 2500 additional potential subjects to be recruited from the vascular laboratory database over the next 5?years. Subjects with a history of VLU prior to the duplex study date will be excluded. Data will be collected via review of the Doppler study report, patient phone interview and review of the electronic medical record. Subjects will be contacted for follow-up every 3 months for at least 5 years until the study endpoint, development of first VLU (fVLU), is reached. In order to estimate the time from reflux documentation to fVLU, Kaplan-Meier survival curves will be constructed. Cox proportional hazard regression models will be constructed to investigate possible risk factors.Ethics and disseminationThis study is approved by the University of Miami's Institutional Review Board. We hope to present the results of this study to the scientific community at conferences and in peer-reviewed journals.
| S-EPMC6326300 | biostudies-literature
Project description:Collaboration with patients in healthcare and medical research is an emerging development. We aimed to develop a methodology for health research agenda setting processes grounded in the notion of participation as dialogue.We conducted seven case studies between 2003 and 2007 to develop and validate a Dialogue Model for patient participation in health research agenda setting. The case studies related to spinal cord injury, neuromuscular diseases, renal failure, asthma/chronic obstructive pulmonary disease, burns, diabetes and intellectual disabilities.The Dialogue Model is grounded in participatory and interactive approaches and has been adjusted on the basis of pilot work. It has six phases: exploration; consultation; prioritization; integration; programming; and implementation. These phases are discussed and illustrated with a case description of research agenda setting relating to burns.The dialogue model appeared relevant and feasible to structure the process of collaboration between stakeholders in several research agenda setting processes. The phase of consultation enables patients to develop their own voice and agenda, and prepares them for the broader collaboration with other stakeholder groups. Challenges include the stimulation of more permanent changes in research, and institutional transitions.
| S-EPMC5060528 | biostudies-literature