Multilayer Compression Therapy Research Articles

Active legs: Impact of physical activity as an adjuvant treatment in the healing of venous ulcers in primary care: a RCT protocol study

BackgroundVenous ulcers usually present a torpid evolution with a negative impact on patients’ quality of life. In primary care, they account for 2.5% of nursing consultations and their treatment represents high costs for national health systems. These patients usually have a low level of physical activity, with muscle pump dysfunction of the lower limbs, which may improve with increased physical activity. The purpose of this study is to analyse the effectiveness of a structured intervention involving physical activity and exercise (Active Legs) as an adjuvant treatment in improving healing of chronic venous ulcers at 3 months follow-up.MethodsA randomized, multicentre clinical trial. A total of 224 individuals receiving primary nursing care with a diagnosis of venous ulcer, with a diameter of 1 cm or greater and an ankle-brachial index between 0.8 and 1.3, able to comply with the study requirements and consenting to participate, will be sequentially included (112 per group).Both groups will receive the standard treatment in primary care, with cleansing, debridement and healing in a moist environment together with multilayer compression therapy. The intervention group will also receive a structured educational intervention involving lower limb physical exercise and daily ambulation guidelines.The primary response variables will be complete healing –understood as complete and sustained epithelialisation for at least 2 weeks– and time to healing. The secondary variables will be degree of healing, ulcer area, quality of life, pain and variables related to the healing process, prognosis, and recurrences. Sociodemographic variables, adherence to treatment and satisfaction variables will also be recorded. Data will be collected at baseline, at 3 months and at 6 months follow-up. Survival analysis (Kaplan-Meier and Cox) will be performed to measure primary effectiveness. Intention-to-treat analysis.DiscussionIf the intervention is effective, a cost-effectiveness analysis could be conducted and implemented as an additional intervention in the usual venous ulcer treatment in primary care.Trial registrationNCT04039789. [https://ClinicalTrials.gov]. 07/11/2019.

Consensus Recommendations for Optimizing the Use of Intact Fish Skin Graft in the Management of Acute and Chronic Lower Extremity Wounds

Background. Since 2017, the clinical use of IFSG has increased substantially in the United States, with some use in Europe and Asia as well. However, scant consensus data have been published on such use. Objective. The authors sought to develop consensus recommendations for the clinical use of IFSG in the management of acute and chronic LEWs. Methods. A panel of 8 expert clinicians in the United States used a 2-cycle NFG process to develop consensus statements based on their own clinical practice and the literature. At their initial meeting in October 2021, panel members discussed the management of DFUs, VLUs, atypical LEWs, and traumatic LEWs in their practices. Consensus statements were drafted, voted on, and rated by relative importance. At the second meeting in October 2022, the panel discussed the initial survey results; a second survey was conducted, and panel members revised the recommendations and indicated the relative importance of each in the final report. A systematic literature review of English-language articles published from January 2016 through November 2022 was conducted as well, using the search terms: “fish skin,” “piscine graft,” “fish tissue,” “intact fish skin graft,” “Cod skin,” “Omega 3 fatty acid graft.” Results. Forty-three statements were generated and grouped into 5 sections comprising general recommendations for LEWs and recommendations specific to DFUs, VLUs, atypical LEWs, and traumatic LEWs. The primary general recommendation is the need to determine wound etiology based on clinical evaluation and reviewing related test results. For DFUs and VLUs, the main recommendations are to adhere to first-line therapy (ie, standard of care, follow conventional guidelines [multilayer compression therapy], offloading, and assessment of wound perfusion) before introducing IFSG. Conclusions. Publications on and clinical experience in the use of IFSGs have increased substantially in the past several years. The 43 consensus recommendations are meant to guide physicians in the optimal use of IFSG in the management of acute and chronic LEWs.

Evaluating the Efficacy of Multilayered Light Compression Therapy in Fasciotomy Wound Closure in Patients Who Underwent Revascularization Procedures: A Case Series and Literature Review

Delayed primary closure is considered standard of care for patients undergoing lower extremity (LE) 4 compartment skin fasciotomies after revascularization for acute limb ischemia (ALI). At our institution, multilayer light compression therapy (MLCT) is used after failure of an initial attempt of delayed primary closure. To assess the efficacy of MLCT as an alternative for wound closure, this strategy was compared with historical controls from negative wound pressure therapy (NWPT). It was hypothesized that our system would be effective and of comparable performance to end points described in the literature and valuable for reducing complications, morbidity, and operational costs associated with other approaches.

Comparative analysis of the effectiveness of the comprehensive antioedema therapy versus multilayer bandaging in lower limbs lymphoedema treatment.

IntroductionTreatment of patients with lymphoedema is time-consuming, labour-intensive, and is frequently associated with considerable costs. In Poland, patients with lower limb lymphoedema encounter major problems with access to the comprehensive antioedema therapy. In many cases treatment is limited only to the compression therapy alone or various forms of lymphatic drainage without compression support. This situation makes it difficult to obtain satisfactory treatment results.AimTo compare the effects of lower limb lymphoedema treatment by means of the multilayer compression therapy alone and the comprehensive antioedema therapy.Material and methodsThirty-four women aged 50–80 years with stage 2 primary lymphoedema of the lower limbs were treated. The therapy was carried out at the Daily Rehabilitation Centre of the Palium Hospice in Poznan. The patients were treated for 2 weeks with the application of the multilayer compression therapy alone (group 1) or the comprehensive antioedema therapy (group 2).ResultsAfter 2 weeks, the volume of treated limbs decreased by 652.9 ±712.2 ml (15.9%) in group 1 and by 523.1 ±448.1 ml (11.2%) in group 2. The range of observed changes was comparable (p = 0.77).ConclusionsAlthough the oedema reduction was significant in both groups, no differences in the degree of the reduction were observed, which depends on the application of both therapeutic techniques. In the short-term treatment, no beneficial effect of the manual lymphatic drainage on the increase of the volume reduction of lower limbs affected by lymphoedema was observed.

17986 A novel approach to creating a chronic wound on lower extremity nonmelanoma skin cancers

Brachytherapy therapy as treatment of nonmelanoma skin cancer is a minimally invasive modality for skin cancer treatment. For elderly patients with medical comorbidities, this is an appealing option. However, in the distal third of the lower extremity, skin tension, poor vascularity, and higher incidence of peripheral arterial disease contribute to poor wound healing. The pathophysiology of radiation exposure to the skin causes endarteritis obliterans, fibrosis, and a hypovascular wound bed serving as poor foundation for wound healing. Our case series suggests skin cancer on the distal third of the leg treated with brachytherapy results in poorly or non-healing wounds as compared with other treatment modalities. Its use should be limited and may require collaboration with a wound healing center in order to manage postprocedural wound healing. We present a series of 10 patients with lower extremity nonmelanoma skin cancers treated with brachytherapy, resulting in nonhealing fibrotic wounds between 3-5 cm in size, taking an average of 2-12 months to heal. Multiple modalities of wound care including advanced dressings, debridement, multilayer compression therapy, and hyperbaric therapy were often employed and necessary to heal the majority of these wounds.

Prospective study of cryopreserved placental tissue wound matrix in the management of chronic venous leg ulcers

ObjectiveChronic venous leg ulcers (VLUs) affect up to 2% of the general population, resulting in a significant socioeconomic burden. Placental tissue that contains mesenchymal stem cells and active growth factors has been shown to be beneficial in healing of chronic wounds. We compared the efficacy of a human viable wound matrix (hVWM) of cryopreserved placental tissue for the treatment of refractory VLUs with standard therapy. MethodsThis prospective single-center open-label single-arm study enrolled patients with Clinical, Etiology, Anatomy, and Pathophysiology clinical class C6 VLUs. The ulcers of all enrolled patients had failed to heal after a trial of standard therapy of at least 12 weeks, which included weekly multilayer compression therapy along with local wound care. The same patients subsequently received application of hVWM (Grafix; Osiris Therapeutics, Columbia, Md) every 1 to 2 weeks in addition to standard therapy. Healing with hVWM therapy was then compared with standard therapy, with each patient serving as his own control. ResultsThere were 30 VLUs in 21 consecutive eligible patients who were enrolled in the study. All patients were men with an average age of 67 years (standard deviation [SD], ±10.8 years), and the average area of venous ulcers before hVWM initiation was 12.2 cm2 (SD, ±14.6 cm2; range, 3.3-12.3 cm2). Duplex ultrasound confirmed superficial or deep system venous reflux in all patients. Complete ulcer healing was achieved in 53% (16/30) of VLUs refractory to standard therapy after application of hVWM. There was a mean reduction in wound surface area by 79% (SD, ±27.3%; P < .001 compared with standard therapy) after a mean treatment time of 10.9 weeks. Eighty percent of VLUs were reduced in size by half compared with 25% with standard therapy (P < .001). The mean rate of reduction in ulcer area after hVWM applications was 1.69% per day vs 0.73% per day with standard therapy (P = .01). ConclusionsCryopreserved placental tissue (hVWM) improves healing processes to achieve complete wound closure in a significant proportion of chronic VLUs refractory to standard therapy. Adjunctive therapy with hVWM provides superior healing rates in refractory VLUs.

Extracorporeal shock wave therapy for the healing and management of venous leg ulcers.

Leg ulcers are chronic wounds of the lower leg, caused by poor blood flow, that can take a long time to heal. The pooling of blood in the veins can damage the skin and surrounding tissues, causing an ulcer to form. Venous leg ulcers are associated with impaired quality of life, reduced mobility, pain, stress and loss of dignity. The standard treatment for venous leg ulcers is compression bandages or stockings. Shock wave therapy may aid the healing of these wounds through the promotion of angiogenesis (the formation and development of blood vessels) and reduction of inflammation, though this process is poorly understood at present. To assess the effects of extracorporeal shock wave therapy on the healing and management of venous leg ulceration. In April 2018 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 scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. We applied no restrictions with respect to language, date of publication or study setting. We considered all published and unpublished randomised controlled trials (RCTs) assessing the effectiveness of extracorporeal shock wave therapy in the healing and management of venous leg ulceration. Two review authors independently performed study selection. We planned that two review authors would also assess the risk of bias of included studies, extract study data and rate the certainty of the evidence using GRADE. We found no RCTs that met the inclusion criteria for this review. We found no RCTs assessing the effectiveness of extracorporeal shock wave therapy in the healing and management of venous leg ulceration. The lack of high-quality evidence in this area highlights a gap in research and may serve to justify the need for further research and evidence to provide guidance concerning the use of this treatment option for this condition. Future trials should be of clear design and include concomitant use of the current best practice treatment, multilayer compression therapy. Recruitment should aspire to best represent patients seen in clinical practice and patient-related outcome measures should be included in study design.

Complex Therapy Physical alone or Associated with Strengthening Exercises in Patients with Lymphedema after Breast Cancer Treatment: a Controlled Clinical Trial

Objective:To compare a complex physical therapy (CPT) protocol alone or combined with complex physical therapy muscle more strength training (CPT+ST) in patients with lymphedema after breast cancer treatment regarding strength and limb muscle volume.Methods:In this controlled clinical trial, consecutive patients treated from breast cancer from April 2014 to December 2015 were allocated in two groups, the CPT group 1 and the CPT+ST group 2, that performed CPT associated with muscle strengthening. Patients in the CPT group 1 received the routine protocol of care, consisting of manual lymphatic drainage (MLD), multilayer bandage compression therapy, skin care and regular exercises. Patients CPT+ST performed, 2 sets of 10 repetitions exercises at 40% of maximal voluntary contraction the first week, increasing to 3 sets with 10 repetitions during the second and third weeks, 3 sets with 15 repetitions, for 8 weeks, 50 minutes per session, twice per week. Strength and muscle volume were analyzed.Result:In the study period, 42 patients were enrolled, 22 in the CPT group 1 and 20 in the CPT+ST group 2. Only 36 completed treatment. Both groups showed similar increases in the range of movement in: shoulder flexion, extension, adduction, abduction and external rotation. Internal rotation showed less improvement in CPT+ST group 2 (p = 0,034). Strength improvement was similar between groups. The CPT+ST group 2 seemed to have a greater volume in the upper limb when compared to CPT group 1, but it was not possible to prove any significant difference (p = 0.555).Conclusion:There was no difference of muscular limb volume between the two interventions. This means that strengthening exercises can be performed by patients with lymphedema safely, without the risk of increasing upper limb volume with edema.

Effect of taping as treatment to reduce breast cancer lymphedema: literature review.

Lymphedema is the most common complication during the postoperative period after surgery for breast cancer and can have a direct impact on daily activities. The objective of this study was to review the use of taping as an alternative/complementary treatment to reduce lymphedema. A literature review was conducted of scientific articles indexed on the PubMed, LILACS, MEDLINE, and PEDro databases and Google Scholar, and nine articles were selected. It was found that taping is a complementary therapy for reducing lymphedema, which may be used as an alternative treatment method, but cannot substitute multilayer compression therapy.

A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix® ) allograft for the treatment of venous leg ulcers.

A randomised, controlled, multicentre clinical trial was conducted to evaluate the efficacy of dehydrated human amnion/chorion membrane (EpiFix) allograft as an adjunct to multilayer compression therapy for the treatment of non‐healing full‐thickness venous leg ulcers. We randomly assigned 109 subjects to receive EpiFix and multilayer compression (n = 52) or dressings and multilayer compression therapy alone (n = 57). Patients were recruited from 15 centres around the USA and were followed up for 16 weeks. The primary end point of the study was defined as time to complete ulcer healing. Participants receiving weekly application of EpiFix and compression were significantly more likely to experience complete wound healing than those receiving standard wound care and compression (60% versus 35% at 12 weeks, P = 0·0128, and 71% versus 44% at 16 weeks, P = 0·0065). A Kaplan–Meier analysis was performed to compare the time‐to‐healing performance with or without EpiFix, showing a significantly improved time to healing using the allograft (log‐rank P = 0·0110). Cox regression analysis showed that subjects treated with EpiFix had a significantly higher probability of complete healing within 12 weeks (HR: 2·26, 95% confidence interval 1·25–4·10, P = 0·01) versus without EpiFix. These results confirm the advantage of EpiFix allograft as an adjunct to multilayer compression therapy for the treatment of non‐healing, full‐thickness venous leg ulcers.

Effective therapy to reduce edema after total knee arthroplasty multi-layer compression therapy or standard therapy with cool pack: A randomized controlled pilot trial

Effective therapy to reduce edema after total knee arthroplasty multi-layer compression therapy or standard therapy with cool pack: A randomized controlled pilot trial

Practice patterns of adjunctive therapy for venous leg ulcers.

Objectives Venous leg ulcers (VLU) are the most severe clinical sequelae of venous reflux and post thrombotic syndrome. There is a consensus that ablation of refluxing vein segments and treatment of significant venous obstruction can heal VLUs. However, there is wide disparity in the use and choice of adjunctive therapies for VLUs. The purpose of this study was to assess these practice patterns among members of the American Venous Forum. Methods The AVF Research Committee conducted an online survey of its own members, which consisted of 16 questions designed to determine the specialty of physicians, location of treatment, treatment practices and reimbursement for treatment of VLUs Results The survey was distributed to 667 practitioners and a response rate of 18.6% was achieved. A majority of respondents (49.5%) were vascular specialists and the remaining were podiatrists, dermatologists, primary care doctors and others. It was found that 85.5% were from within the USA, while physicians from 14 other countries also responded. Most of the physicians (45%) provided adjunctive therapy at a private office setting and 58% treated less than 5 VLU patients per week. All respondents used some form of compression therapy as the primary mode of treatment for VLU. Multilayer compression therapy was the most common form of adjunctive therapy used (58.8%) and over 90% of physicians started additional modalities (biologics, negative pressure, hyperbaric oxygen and others) when VLUs failed compression therapy, with a majority (65%) waiting less than three months to start them. Medicare was the most common source of reimbursement (52.4%). Conclusions Physicians from multiple specialties treat VLU. While most physicians use compression therapy, there is wide variation in the selection and point of initiation for additional therapies once compression fails. There is a need for high-quality data to help establish guidelines for adjunctive treatment of VLUs and to disseminate them to physicians across multiple specialties to ensure standardized high-quality treatment of patients with VLUs.

Extracorporeal shock wave therapy for the healing and management of venous leg ulcers

BACKGROUND Leg ulcers are chronic wounds of the lower leg, caused by poor blood flow, that can take a long time to heal. The pooling of blood in the veins can damage the skin and surrounding tissues, causing an ulcer to form. Venous leg ulcers are associated with impaired quality of life, reduced mobility, pain, stress and loss of dignity. The standard treatment for venous leg ulcers is compression bandages or stockings. Shock wave therapy may aid the healing of these wounds through the promotion of angiogenesis (the formation and development of blood vessels) and reduction of inflammation, though this process is poorly understood at present. OBJECTIVES To assess the effects of extracorporeal shock wave therapy on the healing and management of venous leg ulceration. SEARCH METHODS In April 2018 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 scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. We applied no restrictions with respect to language, date of publication or study setting. SELECTION CRITERIA We considered all published and unpublished randomised controlled trials (RCTs) assessing the effectiveness of extracorporeal shock wave therapy in the healing and management of venous leg ulceration. DATA COLLECTION AND ANALYSIS Two review authors independently performed study selection. We planned that two review authors would also assess the risk of bias of included studies, extract study data and rate the certainty of the evidence using GRADE. MAIN RESULTS We found no RCTs that met the inclusion criteria for this review. AUTHORS' CONCLUSIONS We found no RCTs assessing the effectiveness of extracorporeal shock wave therapy in the healing and management of venous leg ulceration. The lack of high-quality evidence in this area highlights a gap in research and may serve to justify the need for further research and evidence to provide guidance concerning the use of this treatment option for this condition. Future trials should be of clear design and include concomitant use of the current best practice treatment, multilayer compression therapy. Recruitment should aspire to best represent patients seen in clinical practice and patient-related outcome measures should be included in study design.

Diagnostic and treatment decision making in community nurses faced with a patient with possible venous leg ulceration: A signal detection analysis

BackgroundJudgements and decisions about venous leg ulcer management are characterised by uncertainty. Good judgements and reduced variations in practice require nurses to identify relevant “signals” in clinical encounters. Nurses, even experienced ones, vary in their ability to separate these signals from surrounding noise. ObjectivesExamine specialist and generalist nurses’ discrimination of clinical signals and noise when (i) diagnosing venous versus other causes leg ulceration, and (ii) starting multilayer compression therapy. DesignA signal detection analysis within a cross sectional survey. SettingsFour English NHS districts. ParticipantsTissue viability specialist (n=18) and generalist (district and practice nurses, n=18) sampled from networks of nurses caring for people with leg ulcers. Mean age was 46 years, 78% had more than 10 years nursing experience. They worked on average 32.5h per week, of which 10h were spent caring for people with leg ulcers. Methods110 clinical scenarios based on anonymous patient data from a large clinical trial of compression therapy for leg ulceration. The scenarios were classed as either signal (venous leg ulcer present and/or compression therapy warranted, n=57) or no signal cases (other kind of ulcer and/or compression therapy contraindicated, n=53) by four experts. Nurses made diagnostic and treatment judgements for each scenario. A signal detection analysis was undertaken for each nurse. Measures of signal detection (d prime or d′) and judgement tendency or bias (C) were computed. Differences between specialist and generalist nurses were tested for using the Mann Whitney U test and graphically explored using Receiver Operating Curves (ROC). ResultsSpecialists identified more true positive cases than the generalist nurses: 75% vs. 59% for the diagnostic judgement (p<0.01) and 70% vs. 60% for the treatment judgement. They were significantly more sensitive to the signals present (d′ 1.68 vs. 1.08 for the diagnostic judgement and 1.62 vs. 1.11 for the treatment judgement). Specialists exhibited a significantly higher bias towards initiating treatment (C=.81 vs. .56, p<0.01) but this did not extend to their diagnostic judgements. Specialists also varied slightly less in their signal detection abilities. ConclusionsNurse specialism was associated with better, but still variable, clinical diagnostic and treatment signal detection in simulated venous leg ulcer management.

Comparative effectiveness of surgical interventions aimed at treating underlying venous pathology in patients with chronic venous ulcer.

Chronic venous ulcers (CVUs) remain the leading causes for nonhealing wounds in the lower extremities. Although multilayer compression dressing remains the treatment gold standard, there are various surgical procedures aimed at healing CVUs with little or no evidence on the efficacy of these treatment methods. We conducted a systematic review of the effects of various surgical treatments for CVUs, in terms of ulcer healing rates, complete time to heal, recurrence rates, mortality, pain, and quality of life. We searched MEDLINE, EMBASE, the Cochrane Central Register for Controlled Trials, and the Cumulative Index for Nursing and Allied Health Literature databases from January 1980 through July 2012. We included studies that compared a surgical procedure with multilayer compression therapy or another surgical procedure among patients with CVUs. We also included studies without a comparison group if they were of sufficient quality. Two independent reviewers screened titles, abstracts, and articles for eligibility. Two reviewers extracted data on study design, applicability, results, and quality. We identified 10,676 citations, of which 22 studies (23 publications) were included. Eight studies (six randomized controlled trials, two cohorts) compared a surgical procedure with compression. Fourteen studies evaluated different surgical interventions. Adding superficial vein ligation and stripping to compression did not improve wound-healing rate. However, the recurrence rate was 50% reduced when surgery corrected the underlying superficial venous pathology (moderate to high strength of evidence [SOE]). Adding subfascial endoscopic perforator surgery with superficial vein surgery tocompression does not improve the healing rate of venous ulcers or reduce the recurrence rate except for medial and large ulcers (high SOE). The SOE was insufficient to support a conclusion about the effects of sclerotherapy when added to compression in healing CVUs. There was insufficient evidence on the surgical treatment of CVUs secondary to deep venous reflux and venous obstruction. We are unable to draw conclusions about the effects of surgical procedures on mortality, pain, and quality of life. Our ability to draw conclusions on most surgical techniques is limited due to poorly designed and executed studies, with no uniformity of treatment methods, follow-up or reporting, and lack of randomization. We found some evidence to suggest superficial vein ligation and stripping mayreduce the risk of wound recurrence, but these surgical techniques are infrequently performed. The newer minimally invasive techniques lack evidence. Randomized controlled trials for the endovenous procedures used today for treating CVUs are needed.

A new protocol for the treatment of the chronic venous ulcers of the lower limb

Venous leg ulcer is a pathological condition afflicting prevalently elderly patients, which has been found to have a major impact on individuals' health and social aspects of quality of life. Actually, the best practice treatment is recommended to include wound dressing and multilayer compression therapy. In this study, we have tested the effectiveness and safety of Vulnamin(®), a novel dressing in the form of a metal cellulose gel containing the amino acids glycine, L: -lysine, L: -proline, L: -leucine, and hyaluronic acid, and elastic compressive bandages in the treatment of chronic venous ulcers of the lower limbs. The study has been conducted in two groups of patients, one treated with Vulnamin(®) plus Ca-alginate (ulcer duration = 25.4±6.2weeks; mean baseline ulcer area=13.9±4.5cm(2)) and a control group treated with Ca-alginate alone (ulcer duration=23.4±4.2weeks; mean baseline ulcer area=15.1±4.7cm(2)). Results have shown that after 70days of treatment patients significantly ameliorate their pathological condition if they are treated with Vulnamin(®), as compared with patients treated with Ca-alginate alone. In fact, at the end of the treatment, complete healing closure was 61% in the group treated with Vulnamin(®) and, respectively, 27% in the control group. Moreover, ulcer areas showed a significant reduction in patients treated with Vulnamin(®) (mean ulcer area=3.04±0.8cm(2)), as compared with controls (mean ulcer area=10.96±3.8cm(2)). Overall, the results of this study indicate that Vulnamin(®) together with elastocompression is safe and more effective than standard dressing together with elastocompression in inducing a faster healing in chronic venous ulcers of the lower limb.

The ulcerated leg severity assessment score for prediction of venous leg ulcer healing

Conclusion: The Ulcerated Leg Severity Assessment (ULSA) score identifies patients with venous ulcers unlikely to respond to conventional treatment. Summary: Most, but not all, venous ulcers will heal with compression therapy. The authors sought to develop an assessment score to potentially identify patients whose ulcers would not heal with conventional compression therapy and, therefore, should perhaps be offered alternative therapy for ulcer healing early in their course. Baseline factors affecting venous ulcer healing were assessed in patients with venous ulcers seen between March 1999 and August 2001. All patients were initially treated with multilayer compression therapy. Variables related to 24-week healing were identified, and a Cox regression model was developed to identify risk factors that predicted ulcer healing. From this model, a scoring system was developed and subsequently prospectively validated between February 2004 and March 2005. The baseline study included 229 patients with venous ulcers. Patient age, ulcer chronicity, and venous refill time (VRT) of ≤20 seconds were identified as risk factors for nonhealing. The authors used these risk factors and hazard ratios from the Cox analysis and derived the following formula: Ulcerated Leg Severity Assessment (ULSA) score = age + chronicity – 50 (when VRT is >20 seconds). Patients with an ULSA score ≤50 had higher 24-week ulcer-healing rates than those with scores >50. This was in both the baseline study (P < .001) and the follow-up prospective validation study performed in 86 patients (P = .007). Comment: Optimal therapy for venous ulceration continues to be debated. The authors suggest that an elevated ULSA score may indicate patients who early in the course of treatment may benefit from therapies other than compression therapy. Their data, however, shows no benefit with use of these “alternative” therapies. It only identifies individuals who will not do well with compression therapy. It certainly cannot be assumed patients who do not do well with compression therapy will be benefited by alternative therapies. Alternative therapies may also not work well in patients with elevated ULSA scores.

A randomized trial of the Tubulcus multilayer bandaging system in the treatment of extensive venous ulcers

Venous ulcers are a major health problem because of their high prevalence and associated high cost of care. Compression therapy is the most widely used treatment for this condition. The vast majority of published articles on compression therapy present the results in the treatment of venous ulcers usually up to 15 to 20 cm(2). However, there are no published data in English medical literature on the efficacy of compression therapy in the treatment of extensive venous ulcers (ulcers >20 cm(2) of more than 6 months' duration) with regard to healing rate, time to healing, and recurrence rate at 12 months after healing. A total of 138 patients with extensive venous ulceration (ulceration surface, 20-210 cm(2); duration, 7 months to 28 years) were randomized into 2 groups: (1) a treatment group (72 patients who were treated by using a multilayer bandaging system with the Tubulcus (a heelless open-toed elastic compression device knitted in tubular form) and elastic bandages and (2) a control group (66 patients treated with a multilayer bandaging system with elastic bandages only). The patients were treated on an ambulatory basis; the primary end point of the study was complete ulcer healing at 500 days. The secondary end point was to assess the ulcer recurrence rate during continuation of below-knee compression of different degrees of compression. In the treatment group, patients were instructed to continue to wear the Tubulcus (35 mm Hg), and patients in the control group were instructed to wear compression stockings with compression of 20 to 25 mm Hg. The exclusion criteria from the study were heart insufficiency with an ejection fraction <35, an ankle-brachial pressure index less than 0.8, and pregnancy. The cumulative healing rate was 93% in the treatment group and was 51% in the control group (P < .001). The median healing time in the treatment group was 133 days (range, 28 to 464 days), and in the control group it was 211 days (range, 61 to 438 days). The recurrence rate at 12 months in the treatment group was 24% (16/67) and was 53% (18/34) in the control group (P < .05). After additional compression treatment with the same treatment protocol, all 16 recurrent ulcers in the treatment group healed. In the control group, the healing rate of recurrent ulcers was 89% (16/18). This study suggests that for extensive venous ulceration, multilayer compression therapy with the Tubulcus provides an extremely high healing rate. Compression of more than 30 mm Hg results in decreased ulcer recurrence. However, recurrence cannot be completely avoided.