Treatment Of Venous Leg Ulcers Research Articles

Decellularized Dermis Allograft for the Treatment of Chronic Venous Leg Ulceration – the DAVE Randomized Clinical Trial

Decellularized Dermis Allograft for the Treatment of Chronic Venous Leg Ulceration – the DAVE Randomized Clinical Trial

Successful Treatment Of A Chronic Venous Leg Ulcer Using The VenaSeal Closure System

Successful Treatment Of A Chronic Venous Leg Ulcer Using The VenaSeal Closure System

Comparative Effectiveness of Placental Allografts in the Treatment of Diabetic Lower Extremity Ulcers and Venous Leg Ulcers in U.S. Medicare Beneficiaries: A Retrospective Observational Cohort Study Using Real-World Evidence.

Objective: To compare the effectiveness of cellular tissue products (CTP) versus standard care in U.S. Medicare beneficiaries with diabetic lower extremity ulcers (DLEUs) or venous leg ulcers (VLUs). Approach: We performed a retrospective cohort study using real-world evidence from U.S. Medicare claims for DLEUs or VLUs between 2016 and 2020. There were three cohorts evaluated: viable cryopreserved placental membrane (vCPM) or viable lyopreserved placental membrane (vLPM); other CTP; and standard care. Claims were collapsed into episodes of care. Univariate and bivariate statistics were used to examine the frequency distribution of demographics and clinical variables. Multivariable zero-inflated binomial regressions were used to evaluate mortality and recurrence trends. Logistic regression compared three adverse outcomes (AOs): amputation; 1-year mortality; and wound recurrence. Results: There were 333,362 DLEU episodes among 261,101 beneficiaries, and 122,012 VLU episodes among 80,415 beneficiaries. DLEU treatment with vLPM was associated with reduced 1-year mortality (-26%), reduced recurrence (-91%), and reduced AOs (-71%). VLU treatment with vCPM or vLPM was associated with reduced 1-year mortality (-23%), reduced recurrence (-80%), and 66.77% reduction in AOs. These allografts were also associated with a 49% and 73% reduced risk of recurrence in DLEU and VLU, respectively, compared with other CTPs. Finally, vCPM or vLPM were associated with noninferior prevention of AOs related to amputation, mortality, and recurrence (95% CI: 0.69-1.14). Conclusions: DLEUs and VLUs treated with vCPM and vLPM allografts are associated with lowered 1-year mortality, wound recurrence, and AOs in DLEUs and VLUs compared with standard care. Decision makers weighing coverage of placental allografts should consider these added short- and long-term clinical benefits relative to costly management and high mortality of Medicare's most frequent wounds.

The Efficacy of Extracorporeal Shockwave Therapy Compared with Compression Therapy in Healing Venous Leg Ulcers.

Background: Innovative methods of physical therapy delivered via modern medical devices have significantly extended the possibility of applying conservative treatments in healing venous leg ulcers. The primary objective of this study was to compare the therapeutic efficacy of selected mechanical physical therapies (intermittent pneumatic compression vs. radial extracorporeal shockwave vs. focal extracorporeal shockwave) vs. standard care in the treatment of venous leg ulcers over a 4-week period. Materials: This study included 69 patients, comprising 45 females (65%) and 24 males (35%), with a mean age of 67.1 ± 8.6 years (range: from 52.0 to 80.0 years). Methods: The patients were allocated into four groups: the IPC group was treated with intermittent pneumatic compression therapy, the R-ESWT group was treated with radial extracorporeal shockwave therapy, the F-ESWT group was treated with focal extracorporeal shockwave therapy, and the SC group was treated with standard care. Results: After one month of therapy, the median percentage decrease in wound total surface area after treatment was as follows: in the IPC group, there was a 52.9% decrease (range: 3.3-100%); in the R-ESWT group, there was a 31.6% decrease (range: 2.4-95.8%); in the F-ESWT group, there was an 18.0% decrease (range: 1.9-76.1%); and in the SC group, there was a 16.0% decrease (range: 1.5-45.8%). Conclusions: All the studied therapies caused a statistically significant reduction in the surface area of venous leg ulcers. The best results were observed with the intermittent pneumatic compression, while the radial and focal extracorporeal shockwave therapies appeared less effective. The standard care alone turned out to be the least effective. Our results did not show statistically significant changes in the values of RBC deformability at the investigated shear rates.

Sub-ulcer Foam Sclerotherapy in Patients with Venous Leg Ulcer, Analysis and Technical Aspects of 134 Consecutive Patients.

For this retrospective study, we analyzed the sub-ulcer foam sclerotherapy technique in patients with venous leg ulcer (VLU). This study included 134 patients treated with sub-ulcer foam sclerotherapy at the Oulu University Hospital vascular outpatient clinic from January 2012 to December 2021. All included patients received sub-ulcer foam sclerotherapy as part of the treatment strategy for superficial venous insufficiency. Compression therapy and local wound care were organized for VLU treatment. A follow-up visit was scheduled for one month after the sub-ulcer foam sclerotherapy. Change in ulcer size, local (skin necrosis, infection) or systemic (deep vein thrombosis, pulmonary embolism) complications, and time to ulcer healing were monitored. The occurrence of major limb-related complications (amputation, surgical revision) was monitored for one year postoperatively. One month after sub-ulcer treatment, ulcers were smaller or completely healed in 108 (81%) patients. Ulcer healing was completed in 123 (92%) patients at one year and 131 (98%) patients at two years. Complications were recorded in four (3%) patients, three (2%) who were diagnosed with erysipelas requiring antibiotic treatment and one (1%) patient diagnosed with local dermatitis. During the one-year follow-up, no major limb-related complications (surgical revisions or amputations) arose. Sub-ulcer foam sclerotherapy may be a feasible addition to superficial vein reflux elimination in patients with VLU and a low risk for complications.

Comparison of the therapeutic efficacy of magneto-LED therapy and magnetostimulation applied as the adjuvant treatment of venous leg ulcers – preliminary study

ABSTRACT Purpose Venous leg ulcers are chronic wounds that are difficult to cure. The aim of the study was to compare the therapeutic efficacy of two methods of physical medicine – magneto-LED therapy and magnetostimulation, applied as adjuvant treatment in the treatment of venous leg ulcers. Methods The study included 81 patients, 37 male (45.6%) and 44 female (54.3%) ones, age range between 45 and 90 years, with venous leg ulcers. The patients were assigned to two study groups: magneto-LED therapy (group 1) or magnetostimulation (group 2). In both groups, a total of 40 daily procedures were performed. Wound healing was evaluated using computerized planimetry and the pain intensity on numeric rating scale. Results After treatment, the decrease in healing rate in group 1 was statistically significantly higher in comparison to group 2 (p < 0.001), while a statistically significant reduction in the surface area of ulcers was obtained, amounting on the average from 6.34 ± 1.29 cm2 to 2.31 ± 1.25 cm2 in group 1 (p < 0.001), and from 6.52 ± 1.20 cm2 to 4.79 ± 1.17 cm2 in group 2 (p < 0.001). The percentage changes of ulcers area in group 1 (64.21 ± 17.94%) were statistically significantly greater as compared to group 2 (25.87 ± 14.07%) (p < 0.001). After treatment, the decrease in pain relief in group 1 was statistically significantly higher in comparison to group 2 (p = 0.006), while pain intensity after treatment decreased statistically significantly in both compared groups of patients (p < 0.001). Conclusions Magneto-LED therapy and magnetostimulation caused significant reduction of surface area of the treated venous leg ulcers and pain intensity, yet magneto-LED therapy was more efficient. Both evaluated methods also significantly reduced pain intensity.

Early term results of venous leg ulcer treatment in chronic venous disease: a Latam perspective

Early term results of venous leg ulcer treatment in chronic venous disease: a Latam perspective

Integrating new approaches to care in a vascular wound clinic

IntroductionAn evidence-based approach is essential in the treatment of wounds to optimise healing, reduce costs and improve patient outcomes. AimThis case study aimed to demonstrate our model of care, which assesses and manages patients with venous disease and complex wounds. In this case, venous leg ulcer (VLU) was treated with TLC-NOSF dressing and therapeutic compression. The wound was serially assessed using a smart App that gave the patient a graphic representation of their progress. DesignDescriptive Observational Case Study. Clinical careAn evidence-based approach for managing a chronic, severe VLU. The patient was initially seen at the Outpatient Vascular Wound Clinic twice weekly, then every two weeks for conservative sharp wound debridement, skin care, dressing change, and compression therapy using a compression (Ready) wrap. Wound progress was monitored by the digital application ‘Tissue Analytics’, a “purposedesigned digital wound management platform that records, tracks, and analyses wounds”. ResultsWeek 1: On initial review, ulcer length was 3.15cm, width was 3.1 cm, and total surface area was 6.31 cm2. The wound base was mildly sloughy (<25%), with areas of good granulation tissue on view.Week 12: Length was 1.32 cm, width 1.50 cm, and total surface area of 1.45 cm2, a 77% reduction in wound size.Week 24: The length was 0.48 cm, the width was 0.64 cm, and the total surface area was 0.18 cm2. This represented a 97% reduction in wound size.Week 36: Length was 0.01 cm, the width 0.06 cm, with a total surface area of 0.00 cm2. This represented a 99.99% reduction in wound size. ConclusionThe patient’s treatment for a complex venous leg ulcer included the application of TLC-NOSF dressing in combination with individualised therapeutic compression therapy. We found TLC-NOSF was very effective in combination with the best standard of VLU care (i.e. therapeutic graduated compression therapy). The clinician and patient were impressed with the healing rate at 12 weeks, as the wound dimensions were the lowest since the wound started six years ago. This dramatically improved patient concordance and engagement in care. Despite incomplete healing at 36 weeks, the wound-healing journey over the 36 weeks indicated wound closure was close. In addition, using a wound assessment App, the patient could immediately see the benefits of the new treatment, facilitating patient compliance with the treatment.

Venous leg ulcers: a literature review

The purpose of the literature review is to give the reader a general understanding of Venous Leg Ulcers. Understanding the history, pathophysiology, presentation, and treatment of venous leg ulcers is important in the approach and management of venous leg ulcers. Venous leg ulcers have existed since the 1200’s and it is found that early intervention with combined treatments is more efficient in treating venous leg ulcers while also lowering the recurrence rate of the venous leg ulcers

Compression therapies for the treatment of venous leg ulcers: study protocol for a process evaluation in a randomised controlled trial, VenUS 6

BackgroundThe VenUS 6 parallel-group randomised controlled trial (RCT) will compare the clinical and cost-effectiveness of compression wraps, two-layer compression bandage and evidence-based compression therapy, comprising of two-layers of hosiery or four-layer bandages, for healing time of venous leg ulcers. We will conduct an embedded process evaluation to evaluate the implementation of the trial and the various compression therapies and to gain a more in-depth understanding of trial participant and nursing staff views and experiences of these therapies.MethodsThis process evaluation will be a mixed-method study, embedded into a wider RCT. Qualitative data will be collected through semi-structured individual in-depth interviews with trial participants and staff members. Quantitative data will be collected using patient questionnaires and case report forms that are part of the main trial data collection process. Interview transcripts will be analysed using the Framework Analysis and interview data will be integrated with quantitative RCT data using the RE-AIM framework and the Pillar Integration Process.DiscussionWe describe the protocol for a process evaluation, designed to assess the implementation of the various venous leg ulcer compression therapies as evaluated in VenUS6, and the experiences of trial participants and nursing staff using these. This protocol provides one example of how an embedded mixed-method process evaluation can be conducted.Trial registrationISRCTN 67321719 (https://doi.org/10.1186/ISRCTN67321719). Prospectively registered on 14 September 2020.Recruitment Infographic SWAT—MRC Hub for Trials Methodology Research SWAT repository #116. Registered on 13 April 2020.Retention Thank You Card SWAT—MRC Hub for Trials Methodology Research SWAT repository #119. Registered on 13 April 2020.Retention Newsletter SWAT—MRC Hub for Trials Methodology Research SWAT repository #28. Registered on 01 July 2007.Retention Pen SWAT—MRC Hub for Trials Methodology Research SWAT repository #92. Registered on 01 April 2019.Protocol version: V1.5, 26 May 2022.

Exploring the Feasibility of a Self-Managed Lifestyle Intervention, Based on Exercise and Behaviour Support, as an Adjunct Therapy to Compression: A Sub-Study Focusing on People with Venous Leg Ulcers and Early Neuro-Degenerative Diseases (FISCU-NDD).

The aim of this study was to adapt the "FISCU Home" intervention (a co-produced, self-managed and expert-supported lifestyle intervention comprising exercise and behaviour support aimed at people with Venous Leg Ulcers (VLUs), in a way that is suitable for the needs of people with combined VLUs and early-stage, Neuro-degenerative diseases (NDDs), and to explore its feasibility (e.g., estimate rates of recruitment and completion of sessions, calculate study adherence rates, assess participant satisfaction via participant interviews, and assess ease of data collection) within this clinical sub-group. We recruited seven people belonging to this VLUs sub-group (e.g., people with early-stage dementia or Parkinson's), who were ≥18 years' old, had VLU(s) of diameter ≥1 cm, ABPI ≥ 0.8, had the ability to tolerate lower-leg compression and were receiving VLU treatment at home. In Phase 1, participants helped us adapt the intervention. In Phase 2 we carried out a 4-week "training crash-course". This consisted of three, 1 h, self-managed, exercise sessions per week (12 sessions in total), among the participants that completed the interviews. For Phase 3, we carried out post-interviews with all participants to investigate their study experiences, which were analysed using content analysis. All assessments were completed successfully (100% retention and assessment completion), with no exercise-related adverse events. All participants completed the 4-week intervention (100%; all sessions completed by all participants). Our findings suggest that the adapted intervention is feasible, enjoyable and well-received, and has the potential to provide clinical benefits to the participants.

Compression therapy for NHS inpatients with leg ulcers: a literature review.

Leg ulcers are common, distressing and painful for patients, and are a significant financial burden to healthcare providers. Compression therapy is the mainstay of treatment for venous leg ulceration. Several studies have evaluated leg ulcer management and compression therapy in the community. However, little is known about the prevalence of leg ulceration and use of compression therapy in acute hospitals. The aim of this study was to explore the published literature on the use of compression therapy for inpatients with leg ulcers in UK National Health Service hospital settings. A literature search was undertaken to identify published papers reporting on inpatient leg ulcer populations and the use of compression therapy in hospitals using the following databases: CINAHL, MEDLINE Complete, Embase and PubMed. The literature review identified 364 articles, of which three met the eligibility criteria. These studies reported on the prevalence of leg ulceration, the number of Doppler assessments conducted for patients and the use of compression therapy. This review confirmed a lack of information on the prevalence of hospital inpatients with leg ulcers, and identified the need to conduct prevalence audits, establish leg ulcer services to streamline inpatient leg ulcer care and provide staff and patient education programmes.

Lower limb ulcers in people experiencing homelessness

The homelessness crisis in Poland poses a serious challenge to the state, with the number of homeless individuals exceeding 30,000 in 2019. In this paper we highlight one of the most common surgical issue of people experiencing homelessness – venous leg ulcers – and present current treatment guidelines. Homeless individuals, particularly exposed to inadequate living conditions, poor hygiene, and circulatory disorders, are at high risk of developing them. Venous ulcers are chronic wounds with prolonged and complex healing processes.They arise due to venous hypertension associated with chronic venous insufficiency and thrombosis. Often, specialized treatment is necessary, which is a challenge for homeless individuals due to difficulties in accessing regular care.The treatment of venous leg ulcers involves a multi-stage process. The gold standard for managing venous leg ulcers is compression therapy, which reduces edema and venous reflux. The TIME strategy outlines the approach to chronic wound management, emphasizing the importance of initial wound cleansing (surgically, enzymatically, or larvotherapy), infection prevention, maintaining proper moisture and wound edge preparation. This requires the use of suitable antiseptics, dressings, and wound hygiene.People experiencing homelessness face specific issues that necessitate a holistic approach, which includes health education, nutrition, and rehabilitation.

Primary Care Disease Management for Venous Leg Ulceration in German Healthcare: Results of the Ulcus Cruris Care Pilot Study.

Despite proven effectiveness, compression therapy is applied in only 20-40% of patients with venous leg ulceration, leading to avoidable chronification and morbidity. The Ulcus Cruris Care project was established to develop a new disease-management concept comparable to existing programs for chronic diseases to support evidence-based treatment of venous leg ulceration. This prospective controlled study assessed its first implementation. Interventional elements comprised online training for general practitioner practices, software support for case management, and educational materials for patients. A total of 20 practices and 40 patients were enrolled in a 1:1 ratio to the intervention and control group. Guideline-conform compression therapy was applied more frequently in the intervention group (19/20 [95%] vs. 11/19 [58%]; p = 0.006). For patients with ulcers existing ≤ 6 months, the healing rate at 12 weeks was 8/11 [73%] (intervention) compared to 4/11 [36%] (control; p = 0.087). Patients after intervention had higher scores for self-help and education in the PACIC-5A questionnaire (42.9 ± 41.6 vs. 11.4 ± 28.8; p = 0.044). Treatment costs were EUR 1.380 ± 1.347 (intervention) and EUR 2.049 ± 2.748 (control; p = 0.342). The results of this study indicate that the Ulcus Cruris Care intervention may lead to a significant improvement in care. Consequently, a broader rollout in German healthcare seems warranted.

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.

RWD103 Comparative Effectiveness of a Bilayered Living Cellular Construct and a Cryopreserved Cadaveric Skin Allograft for Use in Venous Leg Ulcers

Using real-world data (RWD) we conducted a comparative effectiveness analysis of bilayered living cellular construct (BLCC)(a) versus a cryopreserved cadaveric skin allograft (CCSA)(b) for the treatment of Venous Leg Ulcers (VLUs).

A randomised controlled trial of compression therapies for the treatment of venous leg ulcers (VenUS 6): study protocol for a pragmatic, multicentre, parallel-group, three-arm randomised controlled trial

BackgroundVenous leg ulcer(s) are common, recurring, open wounds on the lower leg, resulting from diseased or damaged leg veins impairing blood flow. Wound healing is the primary treatment aim for venous leg ulceration, alongside the management of pain, wound exudate and infection.Full (high) compression therapy delivering 40 mmHg of pressure at the ankle is the recommended first-line treatment for venous leg ulcers. There are several different forms of compression therapy available including wraps, two-layer hosiery, and two-layer or four-layer bandages.There is good evidence for the clinical and cost-effectiveness of four-layer bandage and two-layer hosiery but more limited evidence for other treatments (two-layer bandage and compression wraps). Robust evidence is required to compare clinical and cost-effectiveness of these and to investigate which is the best compression treatment for reducing time to healing of venous leg ulcers whilst offering value for money. VenUS 6 will therefore investigate the clinical and cost-effectiveness of evidence-based compression, two-layer bandage and compression wraps for time to healing of venous leg ulcers.MethodsVenUS 6 is a pragmatic, multi-centre, three-arm, parallel-group, randomised controlled trial. Adult patients with a venous leg ulcer will be randomised to receive (1) compression wraps, (2) two-layer bandage or (3) evidence-based compression (two-layer hosiery or four-layer bandage).Participants will be followed up for between 4 and 12 months. The primary outcome will be time to healing (full epithelial cover in the absence of a scab) in days since randomisation. Secondary outcomes will include key clinical events (e.g. healing of the reference leg, ulcer recurrence, ulcer/skin deterioration, amputation, admission/discharge, surgery to close/remove incompetent superficial veins, infection or death), treatment changes, adherence and ease of use, ulcer related pain, health-related quality of life and resource use.DiscussionVenUS 6 will provide robust evidence on the clinical and cost-effectiveness of the different forms of compression therapies for venous leg ulceration.VenUS 6 opened to recruitment in January 2021 and is currently recruiting across 30 participating centres.Trial registrationISRCTN67321719. Prospectively registered on 14 September 2020

Compression Therapy for The Treatment of Venous Leg Ulcers: A Clinical Study

Compression Therapy for The Treatment of Venous Leg Ulcers: A Clinical Study

Psychometric Properties of the Traditional Chinese Version of the Venous Leg Ulcer Quality of Life Questionnaire

Symptoms and treatment of venous leg ulcers (VLUs) adversely impact patients' quality of life (QoL). There is no QoL tool that considers the linguistic and cultural specificities of patients with VLU in Taiwan. This study aimed to evaluate the psychometric properties of the traditional Chinese version of the Venous Leg Ulcer Quality of Life Questionnaire (VLU-QoL). The processes of translation and cultural adaptation of the VLU-QoL from English to traditional Chinese included forward translation, back translation, linguistic modification, and expert review. Using a sample of 167 patients with VLU from a hospital in southern Taiwan, the psychometric properties analyzed were internal consistency, test-retest reliability, content validity, convergent validity, and criterion-related. The traditional Chinese version of the VLU-QoL demonstrated good overall internal consistency (Cronbach α = .95) and overall test-retest reliability coefficient (r = 0.98). Confirmatory factor analysis was used to assess the convergent validity of the scale; results showed that the Activity, Psychology, and Symptom Distress constructs had acceptable fit and a structure similar to that of the original scale. The scale had its criterion-related validity verified using the Taiwanese version of the 36-item Short-Form Health Survey, demonstrating a good correlation coefficient r that ranged from -0.7 to -0.2 (P < .001). The Chinese version of the VLU-QoL is valid and reliable for assessing the QoL in patients with VLU, delivering a tool that nurses can use to deliver timely and appropriate care to improve patients' QoL.