Limb Volume Changes Research Articles

Efficacy, safety of and adherence to adjustable compression wraps in the control phase of breast cancer-related lymphedema: A randomized controlled trial.

To evaluate efficacy, safety, and adherence to using adjustable compression wraps (ACWs) for upper limb volume control in women with breast cancer-related lymphedema. Randomized controlled trial at a reference hospital for breast cancer treatment in Brazil. Women in control phase of the breast cancer-related lymphedema. Compared use of ACWs versus compressive mesh. Evaluated before treatment, at 30 days, and 6 months after initiating therapy. The primary outcome was the change in excess limb volume. Secondary outcomes included adherence, incidence of adverse events, functionality, quality of life, and hand grip. Statistical analysis involved calculating the effect size (ES) with a 95% confidence interval. Were included 71 women with mean excess limb volume of 321.79 mL (±194.98). In the 30-day analysis (Time 1), a reduction of 37.6 mL in volume was observed only in the ACW group (p = .041, ES 0.20), with improved functionality (p = .013, ES 0.22). In the six months analysis (Time 2), the compressive mesh group increased by 2.48% in volume (p = .023, ES 0.26) and demonstrated improvement functionality (p = .036, ES 0.27). Mild adverse events and satisfactory adherence were observed. However, in the intergroup comparison, no statistically significant difference was observed for any evaluated outcome-excess volume, incidence of adverse events, adherence, hand grip, quality of life, and functionality between the groups (p > .05) at both times. Both compression therapies achieved satisfactory adherence, were safe, effective and equivalent for controlling limb volume in breast cancer-related lymphedema.

Lymphedema Rates Following Axillary Lymph Node Dissection With and Without Immediate Lymphatic Reconstruction: A Prospective Trial.

Immediate lymphatic reconstruction (ILR) has been proposed to decrease lymphedema rates. The primary aim of our study was to determine whether ILR decreased the incidence of lymphedema in patients undergoing axillary lymph node dissection (ALND). We conducted a two-site pragmatic study of ALND with or without ILR, employing surgeon-level cohort assignment, based on breast surgeons' preferred standard practice. Lymphedema was assessed by limb volume measurements, patient self-reporting, provider documentation, and International Classification of Diseases, Tenth Revision (ICD-10) codes. Overall, 230 patients with breast cancer were enrolled; on an intention-to-treat basis, 99 underwent ALND and 131 underwent ALND with ILR. Of the 131 patients preoperatively planned for ILR, 115 (87.8%) underwent ILR; 72 (62.6%) were performed by one breast surgical oncologist and 43 (37.4%) by fellowship-trained microvascular plastic surgeons. ILR was associated with an increased risk of lymphedema when defined as ≥10% limb volume change on univariable analysis, but not on multivariable analysis, after propensity score adjustment. We did not find a statistically significant difference in limb volume measurements between the two cohorts when including subclinical lymphedema (≥5% inter-limb volume change), nor did we see a difference in grade between the two cohorts on an intent-to-treat or treatment received basis. For all patients, considering ascertainment strategies of patient self-reporting, provider documentation, and ICD-10 codes, as a single binary outcome measure, there was no significant difference in lymphedema rates between those undergoing ILR or not. We found no significant difference in lymphedema rates between patients undergoing ALND with or without ILR.

Techniques for Measuring the Fluctuation of Residual Lower Limb Volume in Clinical Practices: A Systematic Review of the Past Four Decades

Increased pressure and shear stress distributions at the limb–socket interface are hypothesised to result from changes in the residual limb shape and volume, which can cause socket fit difficulties. Accurate residual limb volume measurements may aid clinicians in developing strategies to accommodate volume fluctuations. This review primarily aims to analyse the techniques available for measuring the residual lower limb volume that may be used in clinical settings, as documented in the works published over the previous four decades. A comprehensive search of articles in PubMed, ScienceDirect, Web of Science, and Google Scholar identified 904 articles, and further analysis resulted in only 39 articles being chosen to be analysed. Based on the findings, there are nine techniques available to measure the residual limb volume: water displacement, anthropometric measurement, contact probes, optical scanning, spiral X-ray computed tomography (SXCT), magnetic resonance imaging (MRI), ultrasound, laser scanning, and bioimpedance. Considering the variety of techniques for determining residual limb volume, it is critical to choose the ones that best suit clinicians’ objectives, and each technique has potential sources of error that should be avoided by taking precautionary action. A comprehensive study of the measurement techniques is needed since researchers have developed and extensively utilised many new measuring devices, especially handheld 3D laser scanners.

A high precision laser scanning system for measuring shape and volume of transtibial amputee residual limbs: Design and validation.

Changes in limb volume and shape among transtibial amputees affects socket fit and comfort. The ability to accurately measure residual limb volume and shape and relate it to comfort could contribute to advances in socket design and overall care. This work designed and validated a novel 3D laser scanner that measures the volume and shape of residual limbs. The system was designed to provide accurate and repeatable scans, minimize scan duration, and account for limb motion during scans. The scanner was first validated using a cylindrical body with a known shape. Mean volumetric errors of 0.17% were found under static conditions, corresponding to a radial spatial resolution of 0.1 mm. Limb scans were also performed on a transtibial amputee and yielded a standard deviation of 8.1 ml (0.7%) across five scans, and a 46 ml (4%) change in limb volume when the socket was doffed after 15 minutes of standing.

A Pneumatically Controlled Prosthetic Socket for Transfemoral Amputees.

Amputees typically experience changes in residual limb volume in their daily lives. It causes an uncomfortable fit of the socket by applying high pressure on the sensitive area of the residual limb or by loosening the socket. In this study, we developed a transfemoral prosthetic socket for above-the-knee amputees that ensures a good socket fit by maintaining uniform and constant contact pressure despite volume changes in the residual limb. The socket has two air bladders in the posterior femoral region, and the pneumatic controller is located on the tibia of the prosthesis. The pneumatic system aims to minimize unstable fitting of the socket and improve walking performance by inflating or deflating the air bladder. The developed socket autonomously maintains the air pressure inside the prosthetic socket at a steady-state error of 3 mmHg or less by adjusting the amount of air in the air bladder via closed-loop control. In the clinical trial, amputee participants walked on flat and inclined surfaces. The displacement between the residual limb and socket during the gait cycle was reduced by up to 33.4% after air injection into the socket. The inflatable bladder increased the knee flexion angle on the affected side, resulting in increased stride length and gait velocity. The pneumatic socket provides a stable and comfortable walking experience not only when walking on flat ground but also on slopes.

Daily Duration of Compression Treatment in Chronic Venous Disease Patients: A Systematic Review.

Background: There are no data on the daily regimen of compression therapy in patients with chronic venous disease. This systematic review aimed to establish the optimal daily duration of compression treatment. Methods: A systematic search of CENTRAL and MEDLINE was performed to identify RCTs, non-RCTs, reviews, systematic reviews, meta-analyses, and guidelines evaluating the use of compression regimens in the treatment of varicose veins. Results: Thirty-two RCTs, three non-RCTs, four observational studies, and two crossover trials reporting the duration and regimes of compression treatment fulfilled the inclusion criteria. The daily duration of compression was reported in patients after invasive treatment, for venous ulcer treatment, in patients with venous symptoms. The quality of the studies varied. We could not conduct a meta-analysis due to the heterogeneity of the research data and their quality. Twenty-three studies reported results of compression usage after invasive procedures. Eight studies reported daily duration regimens in patients with venous ulcers. Nine studies reported the impact of compression on venous symptoms and/or edema or limb volume change. One study was conducted to assess if compression improves QoL in venous patients. While there was a clear difference found in the daily duration depending on the clinical scenario, no data in support of exact regimens were found. Conclusions: There are no reliable data supporting exact daily regimens of compression treatment in various cohorts of CVD patients.

Skin microbiome alterations in upper extremity secondary lymphedema.

Lymphedema is a chronic condition that commonly occur from lymphatic injury following surgical resection of solid malignancies. While many studies have centered on the molecular and immune pathways that perpetuate lymphatic dysfunction, the role of the skin microbiome in lymphedema development remains unclear. In this study, skin swabs collected from normal and lymphedema forearms of 30 patients with unilateral upper extremity lymphedema were analyzed by 16S ribosomal RNA sequencing. Statistical models for microbiome data were utilized to correlate clinical variables with microbial profiles. Overall, 872 bacterial taxa were identified. There were no significant differences in microbial alpha diversity of the colonizing bacteria between normal and lymphedema skin samples (p = 0.25). Notably, for patients without a history of infection, a one-fold change in relative limb volume was significantly associated with a 0.58-unit increase in Bray-Curtis microbial distance between paired limbs (95%CI = 0.11,1.05, p = 0.02). Additionally, several genera, including Propionibacterium and Streptococcus, demonstrated high variability between paired samples. In summary, we demonstrate high compositional heterogeneity in the skin microbiome in upper extremity secondary lymphedema, supporting future studies into the role of host-microbe interactions on lymphedema pathophysiology.

Variation in Leg Tissue Dielectric Constant Values of Healthy Young Adult Females With and Without Compression Bandaging.

Background The clinical efficacy of acompression application has been often limited to the assessment of the change in limb volume, change in clinical symptoms (i.e., wound size, pain, range of motion, incidence of cellulitis), or vascular hemodynamics of the whole limb.Assessing compression-related biophysical changes of a localized area, such as around a wound, or in an area outside of an extremity cannot be objectively assessed by these measurements.Tissue dielectric constant (TDC) values, which provide a measure of the local tissue water (LTW) content, offer an alternative method to document variation in the LTW content of the skin in a specific location. The goals of the present research were (1) to characterize TDC values, expressed as percentage tissue water, from multiple areas along the medial aspect of the lower leg of healthy volunteers and (2) to explore the potential utilization of the TDC values to assess change in tissue water content in a localized area following compression applications. Methods TDC was measured at 10, 20, 30, and 40 cm proximal to the medial malleolus on the medial aspect of the right leg of 18 young adult healthy women with an age range of 18-23 years and a body mass index of 18.7 to 30.7kg/m2.. TDC was measured at baseline and after 10 minutes of exercise with compression in place on three separate days during which three different compression applications were assessed: a longitudinal elastic stockinette, a two-layer cohesive compression kit, and a combination of the two.Leg circumferences and compression-related interface pressures were also measured. Results Test-Retest Reliability of circumferential measurements and TDC values evaluated using Intraclass correlation coefficient (ICC 3,1) revealed excellent and moderate-to-good reliability, respectively.Analysis of TDC values along the length of the limb using Friedman's test, revealed a small but statistically significant overall difference among baseline TDC values attributable to a smaller value at 40 cm. The largest difference in cumulative average was 7.7% which occurred between 20 and 40 cm, with all other differences between locations less than 1%.No significant differences between the compression applications were observed. Conclusion The present findings demonstrate the utility of TDC measurements as a modality to assess compression-related changes in the legs of healthy women as a foundation for their potential use in assessing outcomes of compression treatments for persons with lower extremity edema or lymphedema. The absence of a significant change in TDC values in these healthy non-edematous conditions and the demonstrated reliability of the TDC measurements on three different days provides further support for the utility of such applications of TDC measurements. The extension to patients with lower extremity edema or lymphedema needs to be evaluated.

A Prospective Preliminary Study Examining the Physiological Impact of Pneumatic Compression Dosing in the Treatment of Lower Extremity Lymphedema.

Background: Optimal frequency and duration of pneumatic compression device (PCD) therapy for lymphedema is undetermined. This prospective, randomized preliminary study evaluated the impact of different PCD dosing protocols on physiological and patient-reported outcomes (PROs) to estimate treatment effects, assess the responsiveness of various measurement techniques, and identify endpoints for a definitive PCD dosing trial. Methods and Results: Twenty-one patients with lower extremity lymphedema were randomized into three groups for treatment with the Flexitouch advanced PCD: (A) once per day for 1 hour, 12 consecutive days; (B) twice per day in 1-hour treatments, 5 consecutive days; or (C) twice per day in 2-hour treatments, 5 consecutive days. Outcomes measured were changes in limb volume (LV), tissue fluid, tissue tone, and PROs. Those in group A experienced mean (standard deviation) LV reductions of 109 (58) mL (p = 0.003) on day 1 and of 97 (86) mL (p = 0.024) on day 5. Group A also showed possible single-treatment decreases in extracellular fluid volume by bioimpedance spectroscopy (BIS) on day 5. There were no consistent changes in groups B and C. Long-term assessment of LV and BIS showed no clear change. Tonometry, ultrasound, local tissue water, and PROs showed wide variation among participants. Conclusions: LV measurements showed potential benefit for 1-hour daily PCD treatment. A definitive dosing trial should include LV, BIS, and PROs in a comparison of 1- and 2-hour daily treatment protocols conducted over a study period of 4 weeks. These data may inform appropriate outcome measures for other intervention studies in lymphedema.

Doxycycline for the treatment of breast cancer-related lymphedema.

Purpose: Secondary lymphedema is a common complication of cancer treatment for which no effective drug treatments yet exist. Level I clinical data suggests that doxycycline is effective for treating filariasis-induced lymphedema, in which it decreases tissue edema and skin abnormalities; however, this treatment has not been tested for cancer-related lymphedema. Over the past year, we used doxycycline in an off-label manner in patients with breast cancer-related secondary lymphedema. The purpose of this report was to retrospectively analyze the efficacy of this treatment. Methods: Patients who presented to our lymphedema clinic between January 2021 and January 2022 were evaluated, and barring allergies or contraindications to doxycycline treatment, were counseled on the off-label use of this treatment. Patients who wished to proceed were treated with doxycycline (200mg given orally once daily) for 6weeks. After IRB approval of this study, lymphedema outcomes were retrospectively reviewed. Results: Seventeen patients with a mean follow-up of 17.0 ± 13.2weeks were identified in our retrospective review. Although doxycycline treatment had no significant effect on relative limb volume change or L-Dex scores, we found a significant improvement in patient-reported quality of life. Analysis of patient responses to the Lymphedema Life Impact Scale showed a significant improvement in the total impairment score due to improvements in the physical and psychological well-being subscales (p = 0.03, p = 0.03, p = 0.04, respectively). Conclusion: This small, retrospective study did not show significant improvements in limb volume or L-Dex scores in patients with breast cancer-related lymphedema treated with doxycycline. However, our patients reported improvements in quality-of-life measures using a validated lymphedema patient-reported outcome instrument. Our results suggest that doxycycline may be of use in patients with breast cancer-related lymphedema; however, larger and more rigorous studies are needed.

A Survey of Prosthetists' Perspectives on Adjustable-Volume Lower-Limb Prosthetic Sockets

ABSTRACT Introduction Adjustable-volume prosthetic sockets have been available for many years to address residual limb volume changes, although little research has been conducted regarding their efficacy. As such, prosthetists are guided by patient preference, personal experience, and professional perception. The purpose of this study was to explore clinician perceptions and experiences fitting adjustable-volume prosthetic sockets. Materials and Methods An anonymous online survey was distributed to certified prosthetists. The survey contained questions about prosthetists' demographics, whether they had previously fit an adjustable-volume prosthetic socket, whether these fittings were successful, and what challenges they experienced. Those who had not previously fit adjustable sockets were asked what barriers had prevented them from doing so. Results A total of 221 certified prosthetists completed the survey. Of the 195 eligible respondents, 82% had experience in fitting adjustable prosthetic sockets. The most commonly fit socket styles were the RevoFit (n = 123), Socket-less (n = 67), and Infinite (n = 66) sockets. Prosthetists had varied success with the different socket styles, with the RevoFit being the most successful, and the Infinite and Socket-less sockets the least successful. Respondents most frequently noted increased bulk (93% of respondents; n = 181), complicated fabrication (72%; n = 141), and poor cosmesis (65%; n = 127) as challenges faced when fitting adjustable-volume sockets. Some respondents felt these sockets were a useful clinical tool; however, common themes regarding clinical perception of adjustable sockets included issues with cost/reimbursement and appropriateness for only a subset of the population of individuals with amputation only. Other respondents felt that adjustable sockets were either not adequate for clinical use or required improvements before their use would be beneficial. Conclusions There is no majority opinion regarding the benefits and challenges of adjustable sockets among prosthetists. In general, prosthetists feel that adjustable sockets can be used as one of the various tools to accommodate complicated lower-limb fittings. Additional work is needed to provide clinicians with a best practice guideline for providing adjustability within lower-limb sockets. Clinical Relevance The study showed that prosthetists feel that adjustable sockets can be one of the tools used for complicated lower-limb fittings. Additional work is needed to develop a best practice guideline for providing adjustability in lower-limb sockets.

Volume Fluctuations in Active and Nonactive Transtibial Prosthetics Users.

This study aims to evaluate the validity and reliability of the Biosculptor's Bioscanner system in capturing transtibial residual limb volume fluctuations in active and nonactive amputees during walking activity. Residual limb volume was obtained by measuring the limb circumference after amputees walked for 5 to 25 minutes for five consecutive days. The comparison of mean circumference between Bioscanner and manual measurements (i.e., tape measure) showed that the Bioscanner gave a higher estimation of circumference for the different amputees. Short-term changes in girth and volume due to an activity such as walking do not fluctuate uniformly. The results reflected as such as nonconsistence circumference change identified at different locations of the circumference profiles. Both amputees experienced a significant increase in circumference at the distal end of the limbs after 5 minutes of walking (7.35% change in nonactive and 8.83% in active amputees), and the measurement decreased as amputees walked longer. At 4-8 cm below the mid-patella tendon (pressure tolerant areas), both amputees experienced minor changes in the size of their circumference. The residual limb volume calculation resulted in the percentage difference between the two methods ranging from 2.4% to 9.3%. Pearson coefficient correlation obtained showed a high correlation between the two techniques, ranging from 0.97 to 1. The analysis of the limit of agreements showed that the majority of measurements were closed to the mean, suggesting that Bioscanner and manual techniques may be interchangeable and agree with one another. This study has implied that Bioscanner is comparable to the standard measurement method and may serve as an alternative tool in managing daily residual limb volume change.

The efficacy of change in limb volume on functional mobility, health-related quality of life, social appearance anxiety, and depression in patients with lower extremity lymphedema.

This study aims to investigate the impact of change in limb volume on the levels of functional mobility, health-related quality of life, social appearance anxiety, and depression before and after complex decongestive physiotherapy in patients with lower extremity lymphedema. Twenty-seven patients with unilateral lower extremity lymphedema were included. The treatment period was 20 sessions. The outcome measures were the limb volume, the Timed Up and Go test, the Short Form-36, the Social Appearance Anxiety Scale, and the Beck Depression Inventory. A statistically significant decrease in the limb volume (p < 0.001) and statistically significant improvements in the Timed Up and Go test performance (p < 0.001), the Short Form-36 Physical Component Summary score (p < 0.01), the Social Appearance Anxiety Scale score (p < 0.001), and the Beck Depression Inventory score (p < 0.001) were found. No statistically significant difference was found on the Short Form-36 Mental Component Summary score (p > 0.05). The decrease in the limb volume improves the functional mobility, physical health-related quality of life, social appearance anxiety, and depression in patients with lower extremity lymphedema, but not the mental health-related quality of life.

Edema management with compression therapy during volumetric modulated arc therapy for extensive skin field cancerisation - a case study

Non-melanoma skin cancer is the most frequently diagnosed cancer in Australia. Recent advances in radiation therapy (RT) allow large convex areas with extensive skin field cancerisation (ESFC) to be treated using volumetric modulated arc therapy (VMAT). RT doses and volumes are planned by radiation oncologists from pre-treatment computed tomography (CT) scans. Changes in limb volume due to the inflammatory response triggered by radiation can affect planned volumes and result in inaccuracies in dosimetry. We present a case study comparing outcomes with and without compression therapy following wide field VMAT to bilateral lower limbs. As edema can affect dosimetry, we hypothesized that edema management using compression therapy would be beneficial in controlling acute edema during RT. In this case when compression was applied during RT, treatment was able to be completed as planned in comparison to RT without compression where additional breaks in treatment were required due to edema and pain. There has been little published research examining edema management during RT for wide field skin cancerisation, however this case suggests further investigation is warranted to examine the potential value of compression therapy and accurate objective measures during VMAT for ESFC.

Evaluation of the new, patient-adjustable socket system Varos in the early phase of prosthetic rehabilitation: a pilot study.

Current prosthetic sockets often provide limited anatomical fit, especially in patients with residual limb volume changes and fluctuations. To address these issues, Ottobock has developed the Varos Socket, a modular socket that can be adjusted by the user. The aim of this study was to evaluate the potential benefits and acceptance of a newly designed patient-adjustable socket in transfemoral amputees in early phase of prosthetic rehabilitation. A prospective A-B-A pilot study was conducted. The setting of the study was an Orthopedic Rehabilitation Clinic. Ten patients with unilateral transfemoral amputation and recent amputation. All patients underwent a standard rehabilitation program with physical therapy. The outcome measures included the Comprehensive Lower-limb Amputee Socket Survey (CLASS), Score Comfort Scale (SCS), a Socket Fit Scale, frequency of falls and stumbles, perceived pain, and satisfaction. The total CLASS score and three sub-scores (i.e., stability, suspension, comfort) were significantly higher with Varos socket. Significantly improved comfort and quality of socket fit were observed as measured by the Socket-Comfort-Scale and Socket-Fit-Scale and a trend towards reduced residual limb pain. 87.5% of the patients reported higher satisfaction than with the standard socket. The results suggest that the Varos socket improved comfort, stability, suspension, appearance, pain, and satisfaction in transfemoral amputees during the early rehabilitation program. A larger study and a longer observation period are warranted to confirm the results of this study. Quick and easy socket fitting as well as instant adjustability by the patient bear substantial potential to improve and accelerate the rehabilitation process in the early phase after amputation.

Use of Dual-Energy X-Ray Absorptiometry to Assess Soft Tissue Composition in Breast Cancer Survivors With and Without Lymphedema.

Background: In patients with lymphedema (LE), in addition to hand dominance, between-group comparisons of interlimb soft tissue differences need to account for differences in whole-body adiposity, measured directly by dual energy X-ray absorptiometry (DXA) or indirectly by body mass index. No study has evaluated the effects of hand dominance and whole-body adiposity on limb composition in patients with LE. This study's purpose was to compare soft tissue composition of affected and unaffected limbs of women with breast cancer, who did and did not have LE, controlling for dominance and percent body fat. Methods and Results: Whole-body DXA scans were acquired and included measures of percent body fat, upper limb total mass, upper limb fat mass, and upper limb fat-free mass. Participants were classified into one of three groups: women without LE; women with only subjective LE; and women with objective signs of LE at the time of assessment. Differences among the LE groups were evaluated using analysis of variance (ANOVA) and Chi-square analyses. Analysis of covariance (ANCOVA) was used to control for percent body fat and for the affected limb dominance. Compared to women without LE, women with objective signs of LE have greater total limb mass, fat mass, and fat-free mass in their affected limbs, independent of affected side dominance and percent body fat. In addition, the interlimb differences in total mass, fat mass, and fat-free mass were greater for the women with objective signs of LE, compared to the other two groups. Conclusions: DXA is useful in identifying soft tissue changes in patients with LE. Given that limb circumferences measure only changes in limb volume and that bioimpedance provides estimates of extracellular fluid, DXA has the advantage of being able to estimate the volumes of specific tissues in the limb.

Challenges in lower limb lymphoedema assessment based on limb volume change: Lessons learnt from the SENTIX prospective multicentre study

BackgroundLower limb lymphoedema (LLL) is the most disabling adverse effect of surgical staging of pelvic lymph nodes. However, the lack of standardisation of volumetric LLL assessment hinders direct comparison between the studies and makes LLL reporting unreliable. The aim of our study is to report outcomes from a prospective trial that have implications for LLL assessment standardisation. MethodsIn the prospective international multicentre trial SENTIX, a group of 150 patients with stage IA1–IB2 cervical cancer treated by uterine surgery with bilateral sentinel lymph node biopsy was prospectively evaluated by objective LLL assessment, based on limb volume change (LVC) using circumferrential limb measurements and subjective patient-reported swelling. The assessments were conducted in six-month periods over 24 months post-surgery. ResultsPatient LVC substantially fluctuated in both positive and negative directions, which were comparable in frequency up to ±14% change. Thirty-eight patients experienced persistent LVC increase >10% classified as LLL, with nine months median time to onset. Some 34.2% of cases experienced onset later than one year after the surgery. Thirty-three patients (22%) experienced transient oedema characterised as LVC >10%, which resolved without intervention between two consequent follow-up visits. No significant correlation between LVC >10% and a patient-reported swelling was observed. ConclusionsGiven that we observed comparable fluctuations of the the lower-limb volumes after surgical treatment of cervical cancer in both positive and negative direction up to ±14%, the diagnostic threshold for LLL diagnosis based on LVC should be increased to >15% LVC. The distinction of transient oedema from persistent LLL requires repeated measurements. Also, as one-third of LLL cases are diagnosed >1-year post-surgery, a sufficient follow-up duration needs to be ensured. Patient-reported swelling correlated poorly with LVC and should only be used as an adjunct to objective LLL assessment.Trial registration: ClinicalTrials.gov: NCT02494063

Factors Predicting Limb Volume Reduction Using Compression Bandaging Within Decongestive Lymphatic Therapy in Lymphedema: A Multicountry Prospective Study.

Objectives: To identify predictive factors associated with limb volume reduction using different decongestive lymphatic therapy (DLT) systems in patients with lymphoedema, over a period of up to 28 days. Methods: A multicountry (Canada, France, Germany, the United Kingdom) prospective cohort study using (DLT): skin care, exercise, compression bandaging, and manual lymphatic drainage for up to 4 weeks. Reduction in limb volume comparing DLT with (1) standard multilayer bandaging with inelastic material, and with (2) multilayer bandaging with Coban2, together with the identification of factors associated with limb volume changes. Results: Out of 264 patients with upper or lower limb lymphedema, 133 used Coban2 and 131 used standard care. Following DLT, mean limb volume reduction was 941 mL using Coban2 compared with 814 mL using standard care. A difference of 127 mL was found (95% confidence interval -275 to 529 mL, p = 0.53). Of the 176 patients with leg swelling, 166 (94.3%) had a limb volume measurement after 28 days and were included in the risk factor analysis. Of these, 132 (79.5%) were female, with overall mean age of 60.1 years (standard deviation = 14.7), with secondary lymphedema in 102/163 (62.6%). Duration of lymphedema was >10 years in 75/161 (46.6%) and 99/166 (59.7%) were International Society of Lymphology late-stage II/III, indicating longstanding and/or a high frequency of patients with advanced stages of lymphedema. Ninety-one (54.8%) received Coban2 and 75 (45.2%) had standard care. Multivariable factors for a greater leg volume reduction were large initial leg volume (p < 0.001), DLT treatment duration of 4 weeks compared with 2 weeks (p = 0.01), and peripheral arterial disease (p = 0.015). Conclusion: Limb volume changes were found to be similar between groups. Lack of standardization of DLT makes interpretation of effectiveness problematic. There is an urgent need for randomized-controlled trials. Despite this, severe lymphedema with a large limb volume responded well to DLT in this study.

Quality of Life and Costs Within Decongestive Lymphatic Therapy in Patients with Leg Lymphedema: A Multicountry, Open-Label, Prospective Study.

Background: Little is known of the impact in terms of health-related quality of life (HRQoL) and cost-effectiveness with decongestive therapy. Objectives: To examine changes in limb volume, quality of life (QoL), and treatment cost of methods of decongestive lymphatic therapy (DLT). Methods: Patients with chronic edema/lymphedema of the leg were invited to participate in a study of DLT in four countries (United Kingdom, France, Germany, and Canada). In each country two sites were selected. One site used their standard method of DLT in their service, including compression with multilayer bandaging with inelastic material. The other site used a system that included 3M™ Coban 2™ as the bandage treatment alongside other standard components of DLT. Patients were followed for either 2 or 4 weeks depending on the local protocols. At entry, at 2 weeks, and at 4 weeks, patients were assessed by using a health index (EQ-5D), a disease-specific HRQoL tool (LYMQOL) and resource usage was recorded over the treatment period. Results: Of the 165 patients with cost data, 90 were treated with Coban 2 and 75 with standard care compression bandaging. There was good evidence of an improvement in EQ-5D of 0.077 (p < 0.001) in all patients. LYMQOL showed significant improvements (p < 0.001) with lower scores. There were no major differences between the two arms of the study with respect to HRQoL. The number of treatment episodes was higher in those treated with standard care (8.15 vs. 6.37), but the overall treatment cost was higher with Coban 2 (£890.7) compared with standard care (£723.0). Conclusion: QoL improved in the standard care and Coban 2 group bandages, and there was no demonstrable difference between the care systems. Further work is required to examine the role of the individual parts of DLT that provide the greatest benefit to patients and the health systems that support them.

Skin biomechanical properties and leg volume in aging healthy adults.

In adults ageing is accompanied by changes in limb volume and skin biomechanical properties. To explore the relationship between body size, aging, skin biomechanics, and leg volume, VLeg and to define predictive equations linking leg volume with these properties. Sixty-two healthy adults (Age 18-80 years, M:F 45:55) were recruited. Anthropomorphic measures were recorded along with VLeg (via circumferential method) and skin tone, stiffness, and elastance (via tonometry). Regression analysis was performed to define relationship between the measured parameters. In healthy adults bilateral VLeg were the same regardless of leg or sex, 5791 ± 1363 for females and 6151 ± 1203 mls for males. VLeg was positively correlated to body weight, where VLeg (mls)=1058 + 69 × Wt (kg) for females and VLeg (mls)= 539 + 65 × Wt (Kg) of body weight for males. Skin surface biomechanical properties varied with sex, leg volume, and location on the leg with the malleolus exhibiting the stiffest surface. The study shows that anthropometric measures change with sex and leg size are multifactorial and body weight, sex, and skin condition as important determinant factors of leg volume.