Recurrence Of Venous Leg Ulcers Research Articles

Impact of Area Deprivation Index on the Outcomes of Venous Leg Ulcer Healing and Recurrence

Impact of Area Deprivation Index on the Outcomes of Venous Leg Ulcer Healing and Recurrence

Impact of Great Saphenous Vein Ablation on Healing and Recurrence of Venous Leg Ulcers in Patients with Post-thrombotic Syndrome: A Retrospective Comparative Study

Impact of Great Saphenous Vein Ablation on Healing and Recurrence of Venous Leg Ulcers in Patients with Post-thrombotic Syndrome: A Retrospective Comparative Study

Compression for preventing recurrence of venous ulcers.

Up to 1% of adults will have a leg ulcer at some time. Most leg ulcers are venous in origin and are caused by high pressure in the veins due to blockage or damaged valves. Venous ulcer prevention and treatment typically involves the application of compression bandages/stockings to improve venous return and thus reduce pressure in the legs. Other treatment options involve removing or repairing veins. Most venous ulcers heal with compression therapy, but ulcer recurrence is common. For this reason, clinical guidelines recommend that people continue with compression treatment after their ulcer has healed. This is an update of a Cochrane review first published in 2000 and last updated in 2014. To assess the effects of compression (socks, stockings, tights, bandages) for preventing recurrence of venous leg ulcers. In August 2023, we searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase, three other databases, and two ongoing trials registries. We also scanned the reference lists of included studies and relevant reviews and health technology reports. There were no restrictions on language, date of publication, or study setting. We included randomised controlled trials (RCTs) that evaluated compression bandages or hosiery for preventing the recurrence of venous ulcers. At least two review authors independently selected studies, assessed risk of bias, and extracted data. Our primary outcome was reulceration (ulcer recurrence anywhere on the treated leg). Our secondary outcomes included duration of reulceration episodes, proportion of follow-up without ulcers, ulceration on the contralateral leg, noncompliance with compression therapy, comfort, and adverse effects. We assessed the certainty of evidence using GRADE methodology. We included eight studies (1995 participants), which were published between 1995 and 2019. The median study sample size was 249 participants. The studies evaluated different classes of compression (UK class 2 or 3 and European (EU) class 1, 2, or 3). Duration of follow-up ranged from six months to 10 years. We downgraded the certainty of the evidence for risk of bias (lack of blinding), imprecision, and indirectness. EU class 3 compression stockings may reduce reulceration compared with no compression over six months (risk ratio (RR) 0.46, 95% confidence interval (CI) 0.27 to 0.76; 1 study, 153 participants; low-certainty evidence). EU class 1 compression stockings compared with EU class 2 compression stockings may have little or no effect on reulceration over 12 months (RR 1.70, 95% CI 0.67 to 4.32; 1 study, 99 participants; low-certainty evidence). There may be little or no difference in rates of noncompliance over 12 months between people using EU class 1 stockings and people using EU class 2 stockings (RR 1.22, 95% CI 0.40 to 3.75; 1 study, 99 participants; low-certainty evidence). UK class 2 hosiery compared with UK class 3 hosiery may be associated with a higher risk of reulceration over 18 months to 10 years (RR 1.55, 95% CI 1.26 to 1.91; 5 studies, 1314 participants; low-certainty evidence). People who use UK class 2 hosiery may be more compliant with compression treatment than people who use UK class 3 hosiery over 18 months to 10 years (RR for noncompliance 0.69, 95% CI 0.49 to 0.99; 5 studies, 1372 participants; low-certainty evidence). There may be little or no difference between Scholl UK class 2 compression stockings and Medi UK class 2 compression stockings in terms of reulceration (RR 0.77, 95% CI 0.47 to 1.28; 1 study, 166 participants; low-certainty evidence) and noncompliance (RR 0.97, 95% CI 0.84.1 to 12; 1 study, 166 participants; low-certainty evidence) over 18 months. No studies compared different lengths of compression (e.g. below-knee versus above-knee), and no studies measured duration of reulceration episodes, ulceration on the contralateral leg, proportion of follow-up without ulcers, comfort, or adverse effects. Compression with EU class 3 compression stockings may reduce reulceration compared with no compression over six months. Use of EU class 1 compression stockings compared with EU class 2 compression stockings may result in little or no difference in reulceration and noncompliance over 12 months. UK class 3 compression hosiery may reduce reulceration compared with UK class 2 compression hosiery; however, higher compression may lead to lower compliance. There may be little to no difference between Scholl and Medi UK class 2 compression stockings in terms of reulceration and noncompliance. There was no information on duration of reulceration episodes, ulceration on the contralateral leg, proportion of follow-up without ulcers, comfort, or adverse effects. More research is needed to investigate acceptable modes of long-term compression therapy for people at risk of recurrent venous ulceration. Future trials should consider interventions to improve compliance with compression treatment, as higher compression may result in lower rates of reulceration.

Impact of great saphenous vein ablation on healing and recurrence of venous leg ulcers in patients with post-thrombotic syndrome: A retrospective comparative study

BackgroundThe optimal treatment approach for patients with active venous leg ulcers (VLUs) and post-thrombotic syndrome (PTS) associated with great saphenous vein (GSV) reflux remains unclear. To address this gap, we retrospectively compared the outcomes of patients with post-thrombotic VLU with an intact GSV vs those with a stripped or ablated GSV. MethodsWe retrospectively analyzed data from 48 patients with active VLUs and documented PTS, who were treated at a single center between January 2018 and December 2022. Clinical information, including ulcer photographs, was recorded in a prospectively maintained digital database at the initial and follow-up visits. Two patient groups—group A (with an intact GSV) and group B (with a stripped or ablated GSV)—were compared in terms of time to complete healing, proportion of ulcers achieving complete healing, and ulcer recurrence during the follow-up period. ResultsThere were no significant differences in age, gender, initial ulcer size, or ulcer duration between the two groups. All included patients had femoropopliteal post-thrombotic changes. Group A had significantly more completely healed ulcers (33 of 34 ulcers, 97%) compared with group B (10 of 14 ulcers, 71%) (P = .008). Group A also exhibited a significantly shorter time to complete ulcer healing (median: 42.5 days, interquartile range [IQR]: 65) compared with group B (median: 161 days, IQR: 530.5) (P = .0177), with a greater probability of ulcer healing (P = .0084). Long-term follow-up data were available for 45 of 48 patients (93.7%), with a mean duration of 39.6 months (range: 5.7-67.4 months). The proportion of ulcers that failed to heal or recurred during the follow-up period was significantly lower in group A (9 of 32 ulcers, 27%) compared with group B (11 of 13 ulcers, 85%) (P = .0009). In addition, in a subgroup analysis, patients with an intact but refluxing GSV (12 of 34) had a significantly shorter time to heal (median: 34 days, IQR: 57.25) (P = .0242), with a greater probability of ulcer healing (P = .0091) and significantly fewer recurrences (2 of 12, 16%) (P = .006) compared with group B. ConclusionsOur findings suggest that removal of the GSV through stripping or ablation in patients with post-thrombotic deep venous systems affecting the femoropopliteal segment may result in delayed ulcer healing and increased ulcer recurrence. Patients with an intact GSV had better outcomes, even when the refluxing GSV was left untreated. These findings emphasize the potential impact of GSV treatment on the management of VLUs in individuals with PTS. Further investigation is needed to validate these results and explore alternative therapeutic strategies to optimize outcomes for this patient population.

Dehydrated human amnion/chorion membrane to treat venous leg ulcers: a cost-effectiveness analysis.

To evaluate the cost-effectiveness of dehydrated human amnion/chorion membrane (DHACM) in Medicare enrolees who developed a venous leg ulcer (VLU). This economic evaluation used a four-state Markov model to simulate the disease progression of VLUs for patients receiving advanced treatment (AT) with DHACM or no advanced treatment (NAT) over a three-year time horizon from a US Medicare perspective. DHACM treatments were assessed when following parameters for use (FPFU), whereby applications were initiated 30-45 days after the initial VLU diagnosis claim, and reapplications occurred on a weekly to biweekly basis until completion of the treatment episode. The cohort was modelled on the claims of 530,220 Medicare enrolees who developed a VLU between 2015-2019. Direct medical costs, quality-adjusted life years (QALYs), and the net monetary benefit (NMB) at a willingness-to-pay threshold of $100,000/QALY were applied. Univariate and probabilistic sensitivity analyses (PSA) were performed to test the uncertainty of model results. DHACM applied FPFU dominated NAT, yielding a lower per-patient cost of $170 and an increase of 0.010 QALYs over three years. The resulting NMB was $1178 per patient in favour of DHACM FPFU over the same time horizon. The rate of VLU recurrence had a notable impact on model uncertainty. In the PSA, DHACM FPFU was cost-effective in 63.01% of simulations at the $100,000/QALY threshold. In this analysis, DHACM FPFU was the dominant strategy compared to NAT, as it was cost-saving and generated a greater number of QALYs over three years from the US Medicare perspective. A companion VLU Medicare outcomes analysis revealed that patients who received AT with a cellular, acellular and matrix-like product (CAMP) compared to patients who received NAT had the best outcomes. Given the added clinical benefits to patients at lower cost, providers should recommend DHACM FPFU to patients with VLU who qualify. Decision-makers for public insurers (e.g., Medicare and Medicaid) and commercial payers should establish preferential formulary placement for reimbursement of DHACM to reduce budget impact and improve the long-term health of their patient populations dealing with these chronic wounds. Support for this analysis was provided by MiMedx Group, Inc., US. JLD, and RAF are employees of MiMedx Group, Inc. WHT, BH, PS, BGC and WVP were consultants to MiMedx Group, Inc. VD, AO, MRK, JAN, NW and GAM served on the MiMedx Group, Inc. Advisory Board. MRK and JAN served on a speaker's bureau. WVP declares personal fees and equity holdings from Stage Analytics, US.

A Systematic Review Network Meta-Analysis and Meta-Regression on Surgical and Endovenous Interventions for the Treatment of Lower Limb Venous Ulcer Disease.

Venous leg ulcer (VLU) disease constitutes the most severe form of chronic venous insufficiency. We performed a network meta-analysis and meta-regression to investigate the efficacy and safety of the various available interventions in the treatment of VLU. We conducted a systematic research corresponding to the instructions by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement for studies reporting on surgical or endovenous interventions for the treatment of VLU. Following data extraction, we performed a Bayesian network meta-analysis and meta-regression. Primary endpoints included VLU healing and recurrence. The secondary endpoint was postintervention complications. Seventeen studies evaluating the impact of compression monotherapy, radiofrequency ablation (RFA), endovenous laser ablation (EVLA), sclerotherapy, and saphenous vein surgery on VLU treatment, consisting of 2156 patients (2186 VLU) were included. When compared to compression monotherapy, RFA was the only treatment displaying a statistically-significant impact on ulcer healing, odds ratio (OR) 5.80 (95% credibility interval (CI): 1.08-35.07), while EVLA, RR 0.06 (95% CI: 0.00-0.57), sclerotherapy, RR 0.07 (95% CI: 0.00-0.68) and RFA, RR 0.12 (95% CI: 0.01-0.91) were the 3 interventions reducing VLU recurrence. EVLA (SUCRA, 69.65) ranked as the most efficient intervention concerning ulcer recurrence reduction. Regarding postintervention complications, EVLA was the only intervention displaying a statistically-significant increased risk compared to compression monotherapy, RR 14.3 (95% CI: 2.03-172.56). Meta-regression analysis exploring the impact of perforator treatment on VLU failed to predict healing, β = -0.27 (95% CI: -2.55 to 1.85), recurrence, β = -0.02 (95% CI: -2.96 to 2.75) and complication outcomes, β = -0.089 (95% CI: -3.13 to 2.85). During sensitivity analysis, RFA and sclerotherapy failed to sustain their effects on ulcer healing and ulcer recurrence, respectively. In addition, sclerotherapy displayed statistically-significant inferior outcomes compared to both EVLA and RFA regarding ulcer recurrence. This is the first network meta-analysis examining the effect of various interventions on VLU disease. While we have demonstrated the efficacy of RFA and ELVA in ulcer recurrence prevention, our results regarding the impact of RFA and sclerotherapy on VLU healing and recurrence, respectively, should be interpreted with caution. In addition, this review raises questions concerning the value of surgery and perforator interventions in the treatment of VLU. Further research through randomized controlled trials is required. Our review has revealed the significant efficacy of endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) in effectively reducing the incidence of ulcer recurrence when compared to compression monotherapy. These outcomes hold the potential to provide relevant insights to both medical practitioners and patients, thereby informing a more prudent and enlightened decision-making approach. Such informed decisions, aimed at mitigating the recurring occurrence of venous leg ulcers, carry profound significance given the considerable socioeconomic implications associated with this medical condition.

Endovenous ablation for venous leg ulcers.

Venous leg ulcers (VLUs) are a serious manifestation of chronic venous disease affecting up to 3% of the adult population. This typically recalcitrant and recurring condition significantly impairs quality of life, and its treatment places a heavy financial burden upon healthcare systems. The longstanding mainstay treatment for VLUs is compression therapy. Surgical removal of incompetent veins reduces the risk of ulcer recurrence. However, open surgery is an unpopular option amongst people with VLU, and many people are unsuitable for it. The efficacy of the newer, minimally-invasive endovenous techniques has been established in uncomplicated superficial venous disease, and these techniques can also be used in the management of VLU. When used with compression, endovenous ablation aims to further reduce pressure in the veins of the leg, which may impact ulcer healing. To determine the effects of superficial endovenous ablation on the healing and recurrence of venous leg ulcers and the quality of life of people with venous ulcer disease. In April 2022 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scrutinised reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions on the language of publication, but there was a restriction on publication year from 1998 to April 2022 as superficial endovenous ablation is a comparatively new technology. Randomised controlled trials (RCTs) comparing endovenous ablative techniques with compression versus compression therapy alone for the treatment of VLU were eligible for inclusion. Studies needed to have assessed at least one of the following primary review outcomes related to objective measures of ulcer healing such as: proportion of ulcers healed at a given time point; time to complete healing; change in ulcer size; proportion of ulcers recurring over a given time period or at a specific point; or ulcer-free days. Secondary outcomes of interest were patient-reported quality of life, economic data and adverse events. Two reviewers independently assessed studies for eligibility, extracted data, carried out risk of bias assessment using the Cochrane RoB 1 tool, and assessed GRADE certainty of evidence. The previous version of this review found no RCTs meeting the inclusion criteria. In this update, we identified two eligible RCTs and included them in a meta-analysis. There was a total of 506 participants with an active VLU, with mean durations of 3.1 months ± 1.1 months in the EVRA trial and 60.5 months ± 96.4 months in the VUERT trial. Both trials randomised participants to endovenous treatment and compression or compression alone, however the compression alone group in the EVRA trial received deferred endovenous treatment (after ulcer healing or from six months). There is high-certainty evidence that combined endovenous ablation and compression compared with compression therapy alone, or compression with deferred endovenous treatment, improves time to complete ulcer healing (pooled hazard ratio (HR) 1.41, 95% CI 1.36 to 1.47; I2 = 0%; 2 studies, 466 participants). There is moderate-certainty evidence that the proportion of ulcers healed at 90 days is probably higher with combined endovenous ablation and compression compared with compression therapy alone or compression with deferred endovenous treatment (risk ratio (RR) 1.14, 95% CI 1.00 to 1.30; I2 = 0%; 2 studies, 466 participants). There is low-certainty evidence showing an unclear effect on ulcer recurrence at one year in people with healed ulcers with combined endovenous treatment and compression when compared with compression alone or compression with deferred endovenous treatment (RR 0.29, 95% CI 0.03 to 2.48; I2 = 78%; 2 studies, 460 participants). There is also low-certainty evidence that the median number of ulcer-free days at one year may not differ (306 (interquartile range (IQR) 240 to 328) days versus 278 (IQR 175 to 324) days) following combined endovenous treatment and compression when compared with compression and deferred endovenous treatment; (1 study, 450 participants). There is low-certainty evidence of an unclear effect in rates of thromboembolism between groups (RR 2.02, 95% CI 0.51 to 7.97; I2 = 78%, 2 studies, 506 participants). The addition of endovenous ablation to compression is probably cost-effective at one year (99% probability at GBP 20,000/QALY; 1 study; moderate-certainty evidence). Endovenous ablation of superficial venous incompetence in combination with compression improves leg ulcer healing when compared with compression alone. This conclusion is based on high-certainty evidence. There is moderate-certainty evidence to suggest that it is probably cost-effective at one year and low certainty evidence of unclear effects on recurrence and complications. Further research is needed to explore the additional benefit of endovenous ablation in ulcers of greater than six months duration and the optimal modality of endovenous ablation.

Systematic Review and Meta-Analysis of Exercise Therapy For Venous Leg Ulcer Healing and Recurrence

Objective: National guidelines recommend regular exercise for individuals with venous leg ulceration,1 yet data for the effect of exercise on ulcer healing and recurrence are sparse. This study aimed to quantify the evidence for exercise in venous ulcer healing with respect to the primary outcomes of proportion of healed ulcers and rate of ulcer recurrence. Secondary outcomes were improvement in ulcer symptoms, ulcer healing time, quality of life, compliance, and reported adverse events.

VIEW-VLU observational study of the effect of Varithena on wound healing in the treatment of venous leg ulcers

ObjectiveChronic venous hypertension, triggered by venous reflux and/or obstruction, leads to skin changes and venous leg ulcers (VLUs). Compression therapy is the standard of care, but many wounds remain unhealed. The objectives of this study were to observe the effects of endovenous chemical ablation with commercially available 1% polidocanol injectable microfoam on VLU healing and recurrence rates. MethodsThe VIEW VLU study was a multicenter, open-label, phase IV registry of patients with active VLUs resulting from venous insufficiency of the great saphenous vein and/or anterior accessory saphenous vein systems who underwent ablation with 1% polidocanol microfoam. Primary outcomes included wound healing rate (change in wound perimeter), wound closure at 12 weeks after treatment, and time to wound closure. Secondary outcomes included VLU recurrence, numeric pain score at the ulcer location, EuroQol five-dimension five-level questionnaire quality-of-life index, and the Venous Clinical Severity Score. Patients were followed for 12 months. ResultsWe enrolled 76 patients (80 ulcers) from 14 sites across the United States and Canada (mean age 63.6 ± 13.7 years, 39.5% female, mean body mass index 36.3). Of the enrollees, 96.3% presented with great saphenous vein incompetence. The mean baseline wound perimeter was 117.2 ± 107.4 mm and 26.3% of wounds (21/80) were circumferential. The mean ulcer age was 34.8 ± 51.8 weeks at first presentation and the mean compression therapy duration was 26.4 ± 35.9 weeks. The median wound perimeter decreased by 16.3% from baseline in the first 2 weeks after the procedure and by 27.0% at 12 weeks. By 12 weeks, 53.8% of wounds (43/80) were healed. The median time to ulcer closure by Kaplan-Meier analysis was 89 days (95% confidence interval, 62.0-117.0). In a Kaplan-Meier analysis of initially healed wounds, 88.9% (95% confidence interval, 76.9-94.8) remained closed at 12 weeks after closure. The mean numeric pain scores (ulcer site) improved by 41.0% and 64.1% at 12 weeks and 12 months after the procedure, respectively. The health-related quality-of-life index (scale of 0-1) improved from 0.65 ± 0.27 at baseline to 0.72 ± 0.28 at 12 weeks and 0.73 ± 0.30 at 12 months. By 12 weeks after treatment, the mean target leg Venous Clinical Severity Score had significantly decreased by 5.8 points, and by 12 months it had decreased by 10.0 points. ConclusionsTreatment with 1% polidocanol microfoam was associated with promising wound healing rates and low recurrence rates for VLUs, despite a challenging patient population with recalcitrant ulcers, a large percentage of which were circumferential, in patients with high body mass indexes.

Risk factors for the recurrence of venous leg ulcers in adults: A systematic review protocol

BackgroundVenous leg ulcers are slow to heal, and recurrence is frequent. Living with venous leg ulcers can affect physical and psychological health, and result in financial burden for individuals. Physiological and psychosocial factors are associated with venous leg ulcer recurrence. As over 50% of venous leg ulcers will recur within 12 months of healing, a comprehensive knowledge of holistic risk factors associated with recurrence is required by health professionals involved in the care of the person with venous leg ulcers. AimTo develop a systematic review protocol to determine the risk factors for recurrence of venous leg ulcers in adults. Method and AnalysisThis protocol was developed according to the Preferred Reporting Items Form Systematic Review and Meta-Analysis Protocols (PRISMA-P). The inclusion criteria will be based on the PICOS mnemonic-adults with a history of venous leg ulcer/s (participants), risk factor/s under physiological (general/medical), clinical, demographics, psychosocial categories (I (intervention) or E (exposure), venous leg ulcer non-recurrence (comparison group), venous leg ulcer recurrence (outcomes to be measured) and will include study designs of original qualitative, quantitative and mixed method studies (study designs to be included). Methodological quality will be assessed using the Mixed Methods Appraisal Tool. This Systematic Review Protocol was registered in PROSPERO [CRD42021279792]. ResultsIf meta-analysis is not possible, a narrative review of results will be presented. ConclusionsThis systematic review on recurrence of venous leg ulcers can provide evidence-based information for preventive strategies for recurrence of a healed venous leg ulcer. The standardised approach outlined in this systematic review protocol offers a rigorous and transparent method to conduct the review.

180 Systematic Review and Meta-Analysis of Exercise Therapy for Venous Leg Ulcer Healing and Recurrence

Abstract Aim National guidelines recommend regular exercise for individuals with venous leg ulceration, yet data for the effect of exercise on ulcer healing and recurrence are sparse. This study aimed to quantify the evidence for exercise in venous ulcer healing with the primary outcomes of proportion of healed ulcers and rate of ulcer recurrence. Secondary outcomes were compliance and adverse events. Method The review followed PRISMA guidelines using a registered protocol (CRD42021220925). Medline, Embase and Cochrane Databases were searched on 15th March 2021 and included articles comparing exercise to compression therapy. Meta-analysis was performed to pool the data. Results After screening 994 articles, six reports were included with 109 participants allocated to exercise and 113 to compression. All articles were randomised-controlled trials and reported ulcer healing at 12 weeks, with a pooled relative risk of 1.35 ulcers for exercise versus compression (95% CI 1.07 – 1.71). Only one article reported on recurrence and data pooling was not performed, but no difference between exercise and usual care was demonstrated. Adverse events were inadequately reported and seen to be more frequent in the exercise arm. Compliance with exercise ranged from 33–81%. Conclusions There is increasing evidence for exercise as an adjunct to ulcer healing, however, trials were low quality with high risk of bias. This is a crucial innovation as many ulcers recur or fail to heal in spite of surgical correction of underlying venous insufficiency. There is paucity of evidence examining leg ulcer recurrence after exercise programmes and currently no evidence of benefit.

Effects of physical activity as an adjunct treatment on healing outcomes and recurrence of venous leg ulcers: A scoping review.

Healing time is protracted and ulcer recurrence is common in patients with venous leg ulcers. Although compression is the mainstay treatment, many patients do not heal timely. Physical activity may be a clinically effective adjunct treatment to compression to improve healing outcomes. This scoping review provides a broad overview of the effect of physical activity as an adjunct treatment to compression on wound healing and recurrence. We followed the six‐step framework developed by Arksey and O'Malley. We searched electronic databases and trial registration websites for relevant studies and ongoing trials. Two authors independently screened and selected articles. Findings were presented in a descriptive statistical narrative summary. We consulted and presented our findings to the wound consumer group to ensure the relevance of our study. Physical activity interventions in 12 out of the 16 eligible studies consisted of only one component, eight studies were resistance exercises, three studies reported ankle and/or foot range of motion exercises, and one study reported aerobic/walking exercises. The remaining four studies involved multicomponent exercise interventions. Resistance exercise combined with ankle and/or foot range of motion exercise minimised ulcer size on day 12 (intervention group: 4.55 ± 1.14 cm2 vs. control group: 7.43 ± 0.56 cm2) and improved calf muscle pump performance on day 8 (ejection fraction: 40%–65%; residual volume fraction: 56%–40%). We identified one study that reported ulcer recurrence rate with no clinical difference in the intervention group versus the control group (i.e., 12% in intervention vs. 5% in control). Our review identified that resistance exercise was the most common type of physical activity intervention trialled in the published literature. Resistance exercise combined with ankle and/or foot range of motion exercise appears to be effective adjunct treatments; however, the overall evidence is still relatively weak as most programmes had a short intervention period which limited clinical outcomes.

Decreased mobility, lack of social support, haemosiderosis and use of antidepressant medications may predict recurrent venous leg ulcers within 12 months of healing: A prospective longitudinal study

To identify clinical, medical and psychosocial predictors of venous leg ulcer recurrence within 12months of healing. A multi-site study was conducted in Australia in community and hospital outpatient settings. Adults with venous leg ulcers were recruited within 4weeks of healing and data were collected on preventative treatments and health, medical, clinical and psychosocial factors. Follow-up data on recurrences were collected every 3months until ulcer recurrence, or until 12months after healing pending which occurred first. Factors associated with time to recurrence were analysed using a Cox proportional hazards regression model. Secondary data analysis of a multi-site, prospective longitudinal study to validate a risk assessment tool for recurrence. A sample of 143 participants was recruited (51% male, Mage = 73years, SD 13.6). Almost half (49.6%) had an ulcer recurrence within 12months, with a mean time to ulcer recurrence of 37weeks (SE 1.63, 95% CI 33.7-40.1). Factors measured at the time of healing that were significant independent predictors of recurrence were: prescribed antidepressant medications (p = .035), presence of haemosiderosis (p = .006), decreased mobility (longer sitting times) (p = .007) and lower social support scale scores (p = .002). Participants who wore compression systems providing 20mmHg or higher for at least 5days/week were less likely to recur, although not reaching statistical significance (p = .06). Results provide evidence that antidepressant medications, haemosiderosis, decreased mobility and lack of social support are risk factors associated with ulcer recurrence; therefore, these variables are modifiable and could guide early intervention.

Impact of Educational Nursing Intervention on Compression Therapy Adherence and Recurrence of Venous Leg Ulcers: A Quasi-Experimental Study

Following the healing of venous leg ulcers, the primary problems for nursing and patients are adhering to compression therapy and preventing ulcer recurrence. As a result, it is important that patients comprehend their situation. The purpose of this study is to see how an educational nursing intervention affected compression therapy adherence and recurrence of venous leg ulcers in patients with chronic venous leg ulcers. A quasi-experimental design was used, including an intervention, a control group, and before and after assessments. This study was conducted in one of Egypt’s largest teaching hospitals associated with Menoufia University. The 20-month study included 80 adult patients with healed venous leg ulcers. Each participant was randomized to either a control (got regular leg ulcer information) or study (received educational interventions) group. The following tools were used in the study: bio-sociodemographic variables, knowledge evaluation, compression therapy adherence scale, and recurrence follow-up, after 3, 6, and 12 months of implementation. Furthermore, there is a statistically significant difference between the study groups during the pretest (r = 0.885, 0.774, and 0.477, p = 0.002). The use of nursing education increased patients’ understanding and adherence to compression treatment substantially. As a consequence, those with chronic venous leg ulcers may be able to avoid recurrent venous leg ulcers.

Recurrent venous leg ulcers: management in general practice

Venous leg ulcers commonly recur. Annemarie Brown highlights some self-care strategies that patients can use to reduce their risk Chronic venous leg ulcers are commonly seen in general practice and although healing rates for leg ulcers have improved, recurrence rates are high with around 60–70% reported to recur after healing. The primary prevention strategy is the life-long wearing of compression hosiery; however, compliance is low for several reasons including lack of understanding of the need to wear compression hosiery and difficulties applying and removing it. Self-care strategies such as physical exercise and mobility, leg elevation and appropriate skin care, can help to prevent recurrence of venous leg ulcers. Practice nurses are ideally placed to provide this advice, which can help improve patient's quality of life while reducing the financial burden of treating open ulceration for the NHS.

Cooling Intervention (MUSTCOOL) for Prevention of Lower Extremity Ulcer Recurrence: A Randomized Controlled Trial.

The purpose of this study was to test our MUSTCOOL cooling patch intervention on the incidence of venous leg (VLU) and diabetic foot ulcer (DFU) recurrence over a previously healed wound. A 6-month randomized controlled trial. The target population was individuals with previously healed ulcers receiving care in outpatient wound centers in the Southeastern region of the United States. The sample comprised 140 individuals with recently healed ulcers; their average age was 62.4 years (SD = 12 years); 86 (61.4%) were male; and 47 (33.6%) were Black or African American. Participants were randomized to the MUSTCOOL or placebo patch. Both groups received instructions to apply the patch 3 times per week, and engage in standard of care including compression and leg elevation (VLU) or therapeutic footwear and hygiene (DFU). Demographic data were collected at baseline, and incidence measures taken at 1, 3, and 6 months. We also studied whether new ulcers developed on the adjacent leg or foot. Data were reported in frequencies/percentages. One hundred seventeen participants (84%) were analyzed who completed 6 months of study participation. Thirteen percent (9/69) and 17% (12/69) developed a recurrent or new VLU, respectively; 29% (14/48) and 13% (6/48) developed a recurrent or new DFU, respectively. One person in the DFU group developed both a recurrent and new ulcer. For 9 recurrent VLUs, 6 (66.7%) recurred in the MUSTCOOL group and 3 (33.3%) receiving the placebo. Of the 15 recurrent DFUs (includes individual who developed both a recurrent and new ulcer), 10 (66.7%) recurred in the MUSTCOOL group and 5 (33.3%) receiving the placebo. While the incidence of ulcer recurrent was slightly higher in the MUSTCOOL group, this finding was not considered clinically relevant. Overall ulcer recurrence during the 6-month study period was lower than reports in the literature, the time frame in which recurrence rates are highest. The study was prospectively registered with ClinicalTrials.gov on December 10, 2015 (Identifier: NCT02626156)-https://clinicaltrials.gov/ct2/show/NCT02626156.

Getting Ready for Wound Certification: Assessing and Managing Lower Extremity Venous Disease.

Getting Ready for Wound Certification: Assessing and Managing Lower Extremity Venous Disease.

Venous leg ulcer recurrences - The relationship to self-efficacy, social support and quality of life - A mixed method study.

The aim of this study was to explore the occurrence of venous leg ulcer recurrence and the relationship with self-efficacy, social support and quality of life. Furthermore, we investigated the lived experiences of those patients and their understanding of why they developed a recurrence. We used a convergent parallel mixed method design consisting of a cohort and an interpretative phenomenological study arm. Consecutive patients (N=145) were recruited into the study. Between 2014 and 2018, three primary care centres took part in the study. Data collection methods included chart review, administered questionnaires and semi-structured interviews. The incidence of the venous leg ulcer recurrence was 33.1% within the study period. The scores for self-efficacy, social support and venous leg ulcer health-related quality of life show little variation between all measurement points and within subgroups. The qualitative findings identified two main themes: accidentally damaging the skin and avoiding venous leg ulcer recurrences. Venous leg ulcer recurrences frequently arose from accidents. Therefore, participants developed strategies to avoid additional ulcers. To optimize recurrence prevention, improvements in knowledge of people with VLUs should be considered. A mixed method, convergent, parallel design was used to explore the occurrence of venous leg ulcer recurrence and the relation of a venous leg ulcer recurrence with self-efficacy, social support and health-related quality of life. As well as the lived experiences of venous leg ulcer patients and why they developed a recurrence. The incidence of venous leg ulcer recurrences within the study period was 33.1%. Damaging the skin and avoiding a recurrence were the main identified themes.

Development and feasibility of a multidisciplinary education program on adherence to treatment in persons with venous leg ulcers in the clinical setting: A pilot study.

The aim of this study is to: (a) develop an evidence-based multidisciplinary educational intervention for patients with a venous leg ulcer; and (b) conduct a pilot study to assess the feasibility of the intervention in the clinical setting. A two-stage study design was used: (a) an multidisciplinary expert committee designed an educational intervention including support materials; and (b) a pilot randomized controlled trial was conducted to assess the feasibility of the intervention in one wound care outpatient clinic in Western Switzerland. A multidisciplinary expert committee identified evidence for effective care interventions to improve venous leg ulcer patients' wound healing and recurrences rates. They subsequently designed the educational intervention and support materials. In this pilot study venous leg ulcer patients were then randomly assigned to receive multidisciplinary education or standard care from March-July 2018. The objective was to evaluate the feasibility of the intervention in the clinical setting. Allocation to groups was achieved to concealed, simple randomization. Participants and study nurses were not blinded, data analyst was blinded. The intervention, including support material was developed. Twelve of 16 invited venous leg ulcer patients were recruited and randomized (control group N=6; intervention group N=6). Participation rate was 75%. The implementation of the intervention was feasible in the clinical setting. The performance of the Venous Leg Ulcer Self Efficacy Tool for measuring adherence to therapy and the Mini Nutritional Assessment and Frequent Food Questionnaire for the assessment of the nutritional intake was satisfactory. However, Fitbit smartwatch for measuring activity was not a suitable device in this study population. The implementation of the designed multidisciplinary educational program was feasible. The pilot study identified weaknesses in the study protocol, which will be amended for the full-size clinical trial. Findings of the pilot study informed the improvement of the design of the main study.

Clinical and economic burden of wound care in the tropics: a 5-year institutional population health review.

The aim of this study is to evaluate the clinical and economic burden of wound care in the Tropics via a 5-year institutional population health review. Within our data analysis, wounds are broadly classified into neuro-ischaemic ulcers (NIUs), venous leg ulcers (VLUs), pressure injuries (PIs), and surgical site infections (SSIs). Between 2013 and 2017, there were a total of 56 583 wound-related inpatient admissions for 41 461 patients, with a 95.1% increase in wound episodes per 1000 inpatient admissions over this period (142 and 277 wound episodes per 1000 inpatient admissions in 2013 and 2017, respectively). In 2017, the average length of stay for each wound episode was 17.7 days, which was 2.4 times that of an average acute admission at our institution. The average gross charge per wound episode was USD $12 967. Among the 12 218 patients with 16 674 wound episodes in 2017, 71.5% were more than 65 years of age with an average Charlson Comorbidity Index (CCI) of 7.2. Half (51.9%) were moderately or severely frail, while 41.3% had two or more wound-related admission episodes. In 2017, within our healthcare cluster, the gross healthcare costs for all inpatient wound episodes stand at USD $216 million within hospital care and USD $596 000 within primary care. Most NIU patients (97.2%) had diabetes and they had the most comorbidities (average CCI 8.4) and were the frailest group of patients (44.9% severely frail). The majority of the VLU disease burden was at the specialist outpatient setting, with the average 1-year VLU recurrence rate at 52.5% and median time between healing and recurrence at 9.5 months. PI patients were the oldest (86.5% more than 65 years-old), constituted the largest cohort of patients with 3874 patients at an incidence of 64.6 per 1000 admissions in 2017, and have a 1-year all-cause mortality rate of 14.3%. For SSI patients, there was a 125% increase of 14.2 SSI wound episodes per 1000 inpatient admissions in 2013 to 32.0 in 2017, and a 413% increase in wound-related 30-day re-admissions, from 40 in 2013 (4.1% of all surgeries) to 205 (8.3% of all surgeries) in 2017. The estimated gross healthcare cost per patient ranges from USD $15789-17 761 across the wound categories. Similar to global data, there is a significant and rising trend in the clinical and economic burden of wound care in Tropics.