Predicting the Likelihood of Delayed Venous Leg Ulcer Healing and Recurrence: Development and Reliability Testing of Risk Assessment Tools.

Venous leg ulcers are characterized by a long healing process and repeated cycles of ulceration. A secondary analysis of data from multisite longitudinal studies was conducted to identify risk factors for delayed healing and recurrence of venous leg ulcers for development of risk assessment tools, and a single-site prospective study was performed to as- sess the new tools' interrater reliability (IRR). The development of the risk assessment tools was based on results from previous multivariate analyses combined with further risk factors documented in the literature from systematic reviews, randomized controlled trials, and cohort studies with regard to delayed healing and recurrence. The delayed healing tool contained 10 items, including patient demographics, living status, use of high-compression therapy, ulcer area, wound bed tissue type, and percent reduction in ulcer area after 2 weeks. The recurrence tool included 8 items, including his- tory of deep vein thrombosis, duration of previous ulcer, history of previous ulcers, body mass index, living alone, leg elevation, walking, and compression. Using consensus procedures, content validity was established by an advisory group of 21 expert multidisciplinary clinicians and researchers. To determine intraclass correlation (ICC) and IRR, 3 rat- ers assessed 26 patients with an open ulcer and 22 with a healed ulcer. IRR analysis indicated statistically signi cant agreement for the delayed healing tool (ICC 0.84; 95% con dence interval [CI], 0.70-0.92; P <.001) and the recurrence tool (ICC 0.88; 95% CI, 0.75-0.94; P <.001). The development and reliability results of these risk assessment tools meet the recommendations for evidence-based, reliable tools and may bene t clinicians and patients in the management of venous leg ulcers. Studies to examine the items with low ICC scores and to determine the predictive validity of these tools are warranted.

The effect of a nurse-directed intervention to reduce pain and improve behavioral and physical outcomes in patients with critically colonized/infected chronic leg ulcers.

PURPOSE: We compared a WOC nurse-directed, patient-centered intervention called MECALF (motivational enhancement and conditioning activity for leg function) compared to conditioning activities for lower leg function (CALF) alone. Outcomes were study feasibility, pain, motivation, self-efficacy, physical activity, leg strength, and range of motion. DESIGN: Comparative study. SUBJECTS AND SETTING: The sample was drawn from 2 wound centers in the Southeastern United States. Twenty-one patients (n = 12 MECALF site A and n = 9 CALF site B) with painful lower legs and critically colonized/infected wounds participated in the study. METHODS: All patients received usual wound care per center protocol. The MECALF intervention was delivered by WOC nurses for 6 weeks at site A and a handout of CALF depicting the conditioning activities was provided by site staff (not WOC nurses) to patients at site B. We assessed study feasibility with postsurvey questionnaires given to WOC nurses (training usefulness, ease of use of ME with patients) and subjects (able to perform activities, use logs). Pre- and postintervention outcome data were collected by study staff using pain, motivation, and self-efficacy scales, functional measures of physical activity, and physical measures of strength and range of motion. RESULTS: The study was found to be somewhat feasible by the WOC nurses and patients. WOC nurses had time management problems using MECALF during usual patient care. Patients reported that they were able to perform CALF. Overall pain was statistically significantly reduced (P = .046) in both groups of patients with painful critically colonized/infected leg ulcers measured at week 8, 2 weeks after the study period. The CALF group experienced a slightly greater reduction in pain intensity than did the MECALF group. No statistically significant differences between the groups were observed in behavioral outcomes for motivation (P = .641) and self-efficacy (P = .643), or for physical outcomes including overall ankle strength (P = .609) and ankle range of motion (P = .498). Functional and physical activity scores revealed no statistically significant differences in 3 measures, including Timed Up and Go test (P = .624), Timed Chair Standing Test (P = .686), or the Community Health Activities Model for Seniors (P = .803). CONCLUSION: While somewhat feasible to implement in the wound care setting, no improvement in outcomes was observed with the addition of the WOC nurse-directed intervention. However, pain in the lower legs of patients with critically colonized/infected wounds in both groups improved after a 6-week behavioral/physical activity intervention. A larger trial is needed to further elucidate these findings.

Evaluation of Vashe Wound Therapy in the clinical management of patients with chronic wounds.

OBJECTIVE: To analyze if Vashe Wound Therapy (PuriCore, Malvern, Pennsylvania) is a valuable contribution to standard protocols of wound care. DESIGN: Open, noncomparative study. SETTING: Outpatient clinic. PATIENTS: Thirty-one patients, primarily with venous or mixed venous/arterial leg ulcers. INTERVENTIONS: Vashe Wound Therapy (hypochlorous acid, produced on site and on demand) was used as an adjunct to a standard wound care protocol. MAIN OUTCOME MEASURES: Wound healing, reduction of pain, and odor. MAIN RESULTS: At the end of the study, 86% of all lesions healed, and the average size of reduction in nonhealed wounds was 47%. Odor was present at the beginning of enrollment in 21 patients and was rated 4.58 on the visual analog scale. In all patients, the odor score at end of treatment was zero. Seventy-seven percent of all patients reported a positive pain score at the beginning of participation in the evaluation (average pain score, 4.7). At the end of the study, no patient experienced pain. CONCLUSION: Vashe Wound Therapy is a valuable contribution to standard protocols of wound care.

Uso da eletroestimulação de alta voltagem na cicatrização de úlceras venosas / Use of high voltage electrical stimulation in healing of venous ulcers

INTRODUÇÃO: A utilização de correntes exógenas como a eletroestimulação de alta voltagem provoca aumento das cargas elétricas no tecido, promovendo efeitos fisiológicos favoráveis que disparam o processo de reparação tecidual. OBJETIVO: Verificar as variações nas áreas das úlceras venosas após a utilização da estimulação elétrica de alta voltagem. MÉTODO: Estudo prospectivo, randomizado e simples cego em que seis indivíduos portadores de úlcera venosa foram divididos aleatoriamente em 2 grupos de tratamento, nos quais foram usados a estimulação elétrica de alta voltagem (20ìs; 100Hz) por 30 minutos em três dias alternados na semana, até atingirem 24 aplicações, sendo o parâmetro da voltagem modulado em zero para o grupo controle e 180 V para o grupo experimental. O programa Autocad foi utilizado para o cálculo das áreas que foram analisadas pelos testes estatísticos de Wilcoxon e Mann-Whitney, com nível de significância de pd"0,05. RESULTADOS: observou-se que não houve diferença estatisticamente significativa entre as áreas das úlceras nos dois grupos pesquisados (p=0,3287), sendo que em apenas um paciente não ocorreu diminuição das áreas das úlceras. CONCLUSÃO: Percebeu-se que a utilização da eletroestimulação de alta voltagem em úlceras venosas de membros inferiores foi ineficaz no tratamento dos pacientes pesquisados.

INTRODUCION: The use of external currents through the high voltage electrical stimulation provokes an increase of electric charges on cells, exercising favorable physiologic effectsthat shoot the process of cellular repairing. OBJECTIVE: to verify the variations in the areas of the venous ulcers after the use of the electrical stimulation of high voltage. METHOD: study prospective, randomized and blind in that six individuals with venous ulcer were divided randomly in 2 groups for treatment and used high voltage electrical stimulation (20μs; 100Hz), 30 minutes of application in three alternate days in the week, until reach 24 applications. The parameter of the voltage was modulated in zero for the group control and 180V for the experimental group. The software Autocad® was used for the calculation ofthe areas, that were analyzed by the statistical tests of Wilcoxon and Mann-Whitney, with level of significant of pd” 0.05. RESULTS: observed that there was no statistically significantdifference between the areas of ulcers in the two groups searched (p = 0.3827), and in just a patient didn’t happen decrease of the areas of the ulcers. CONCLUSION: noticed that theuse of the electrical stimulation of high voltage in venous ulcers of inferior members was ineffective in the treatment of studied patients.

Eficacia de la fisioterapia en la insuficiencia venosa crónica en evolución / Efficacy of physical therapy in chronic venous insufficiency in evolution

Objetivos: Estudiar la eficacia de la fisioterapia en la insuficiencia venosa y la úlcera como complicación de ésta. Método: Búsqueda realizada en PEDro (puntuación mayor de 6), Cochrane, MEDLINE y CEBP. Resultados: El edema venoso se redujo hasta 2,2ml mediante movilizaciones activas y derivación circulatoria. En la úlcera venosa se comprobó que el ultrasonido no fue eficaz tras la revisión de siete ensayos; en cuatro se comparó con el ultrasonido simulado y en los tres restantes se cotejó con un tratamiento estándar. Otros estudios con ultrasonidos pulsátil de 0,5W/cm2 a 1MHz durante 12 semanas tampoco evidenciaron mejoría. El láser no mostró significación para la úlcera si bien evidenció sus efectos terapéuticos en aplicación combinada con luz infrarroja. Conclusiones: La cinesiterapia de la bomba venomuscular periférica es eficaz en la insuficiencia venosa. Los tratamientos mediante láser y ultrasonidos en forma aislada no modifican la evolución de la úlcera flebostática(AU)

Objectives: To study the effectiveness of physical therapy in venous insufficiency and ulcer as a complication of it. Method: Search conducted in PEDro (score greater than 6), Cochrane, MEDLINE and CEBP. Results: Venous edema was reduced to 2.2 cc by active mobilizations and circulatory shunt. It was found that ultrasound was not effective on the venous ulcer after 7 trials were reviewed. Sham ultrasound was compared in 4 of them and the remaining 3 were collated with the standard treatment. Other studies with ultrasound pulses of 0.5W/cm2 to 1MHz for 12 weeks also showed no improvement. Laser showed no significance for the ulcer although its therapeutic effects were verified when it was combined with infrared light. Conclusions: Pump kinesiotherapy is effective in venomuscular peripheral venous insufficiency. Therapeutic laser and ultrasound when used separately do not alter the development of the phlebostatic ulcer(AU)

Functional ability in female leg ulcer patients--a challenge for physiotherapy.

BACKGROUND AND PURPOSE: Venous leg ulceration represents a global health problem affecting predominantly elderly women. Traditionally, functional problems in this group of patients have attracted modest attention from wound care providers and physiotherapists. The aim of the present study was to describe and quantify disease consequences in female leg ulcer patients as a background for future physiotherapy interventions, using the nomenclature of the WHO International Classification of Functioning, Disability and Health (ICF). METHOD: A prospective study was conducted in 34 women aged 60-85 years with current or previous venous leg ulcer as compared to 27 age-matched non-ulcer subjects. The outcome variables were pain, ankle range of motion, walking speed, walking endurance, self-perceived exertion, mobility, activities of daily living (ADL), physical activity, general health, life satisfaction and use of walking aids and community services. Established instruments were utilized and categorized within ICF domains to provide a conceptual framework and basis for physiotherapeutic research. RESULTS: Leg ulcer patients showed significantly reduced values of ankle range of motion, walking speed and endurance, self-perceived exertion, mobility, ADL and physical activity level as compared to control subjects. Patients suffering from active ulceration were more negatively affected, and more of them had pain than post-ulcer fellows. By contrast, general health and life satisfaction were similarly rated by the two study groups. CONCLUSIONS: Elderly females in our study with chronic leg ulcer of venous aetiology had significant mobility impairments, but the reasons and consequences of these impairments remain to be elucidated. The potential of preventive measures and physical rehabilitation to aid functioning and prospects of leg ulcer repair need to be investigated in future studies.

Telerehabilitation for veterans with a lower-limb amputation or ulcer: Technical acceptability of data.

A study was undertaken to determine the technical acceptability of information available via a customized telerehabilitation system regarding patients with lower-limb ulcers or recent lower-limb amputations receiving care at a Veterans Affairs Medical Center. Among the 54 participants, 57 wounds (39 ulcers, 19 amputation incisions) were evaluated by means of still photographs and skin temperature data sent via ordinary telephone lines. Three experienced clinicians served as raters. Intrarater agreements and McNemar chi(2) tests were assessed between decisions made after telerehabilitation sessions and decisions made by the same rater after in-person sessions. Interrater agreements and kappa coefficients were assessed between two raters for both telerehabilitation and in-person sessions. The intrarater agreement on 57 wounds for the primary rater was 93%, and the McNemar test indicated no significant difference in the ratings (p < 0.63). Interrater agreement on 18 wounds was 78% (kappa = 0.55, p < 0.02) for the telerehabilitation sessions and 89% (kappa = 0.77, p < 0.001) for the in-person sessions. Most qualitative comments by three clinicians on picture quality (54/63 = 86%) and temperature data (39/44 = 88%) were favorable (good to excellent). The information yielded from this study provides evidence that the telerehabilitation system has the potential to present sufficient information to experienced clinicians so they can make informed decisions regarding wound management. The next phase of the study will include in-home trials and improvements in the technology.

Implementation of a leg ulcer strategy.

BACKGROUND: The care of patients with leg ulceration has developed over the past 15 years, although there is little information available to determine how these changes have affected clinical and patient defined outcomes. OBJECTIVES: To describe and evaluate the implementation of a leg ulcer strategy. PATIENTS/METHODS: This study used a pre- and postimplementation evaluation within population-based services within the boundaries of community services providing leg ulcer care. Evidence-based leg ulcer services were developed, including standardized assessment using Doppler ultrasound, rationalization of treatment using multilayer elastic high compression, development of referral criteria and acute service support. Complete ulcer healing rates, health-related quality of life and use of health resources were evaluated after 12 weeks in both pre- and postimplementation cycles. RESULTS: A total of 955 patients were evaluated (518 preimplementation, 437 postimplementation). The levels of assessment and treatment were poor prior to the change in practice with just one patient having evidence of correct assessment and 49 (11%) receiving high compression therapy. Postimplementation, this improved to 412 of 437 (94%) having evidence of measurement of the ankle brachial pressure index, and 85% receiving compression. Twelve-week healing rates preimplementation ranged between 9% and 24%, and postimplementation rose from 19% to 39%. Combined overall healing rates improved from 71 of 518 (14%) to 160 of 437 (37%), odds ratio =3.53, P < 0.001. Frequency of treatment visits reduced from a mean (SD) of 24.0 (16.1) over 12 weeks to 13.5 (8.6), P < 0.001. Intervention led to major improvements in health-related quality of life (measured using the Nottingham Health Profile), with significant improvements for energy, pain, sleep and mobility (P < 0.01). CONCLUSIONS: Rationalization of leg ulcer services through a total service change results in improvements in professional practice, better patient outcomes, and efficient use of current resources. This study highlights the importance of a multifaceted approach to improve practice focused on the needs of individual organizational settings.

Economic analysis of VenUS I, a randomized trial of two bandages for treating venous leg ulcers.

BACKGROUND: The study investigated the cost-effectiveness of four-layer and short-stretch compression bandages for treating venous leg ulcers. METHODS: Cost-effectiveness and cost-utility analyses were performed using patient-level data collected alongside the VenUS I leg ulcer study. The perspective for the economic analysis was that of the UK National Health Service (NHS) and Personal Social Service. The time horizon for the analysis was 1 year after recruitment. Health benefit was measured as differences in ulcer-free days and quality-adjusted life years (QALYs). RESULTS: The mean healing time for ulcers treated with four-layer bandages was 10.9 (95 per cent confidence interval (c.i.) -6.8 to 29.1) days less than that for ulcers treated with short-stretch bandages. Mean average difference in QALYs between compression systems was -0.02 (95 per cent c.i. -0.08 to 0.04). The four-layer bandage cost a mean of pound 227.32 (95 per cent c.i. pound 16.53 to pound 448 .30) less per patient per year than the short-stretch bandage. CONCLUSION: On average, four-layer bandaging was associated with greater health benefits and lower costs than short-stretch bandaging.

Effect of electrical stimulation on chronic leg ulcer size and appearance.

BACKGROUND AND PURPOSE: Electrical current has been recommended for use on chronic pressure ulcers; however, the ability of this modality to improve healing of other types of chronic ulcers is less well established. The purpose of this study was to examine the effect of high-voltage pulsed current (HVPC) on healing of chronic leg ulcers. SUBJECTS: Twenty-seven people with 42 chronic leg ulcers participated in the study. METHODS: The subjects were separated into subgroups according to primary etiology of the wound (diabetes, arterial insufficiency, venous insufficiency) and then randomly assigned to receive either HVPC (100 microseconds, 150 V, 100 Hz) or a sham treatment for 45 minutes, 3 times weekly, for 4 weeks. Wound surface area and wound appearance were assessed during an initial examination, following a 1- to 2-week period during which subjects received only conventional wound therapy, after 4 weeks of sham or HVPC treatment, and at 1 month following treatments. RESULTS: The results indicated that HVPC applied to chronic leg ulcers reduced the wound surface area over the 4-week treatment period to approximately one half the initial wound size (mean decrease=44.3%, SD=8.8%, range=2.8%-100%), which was over 2 times greater than that observed in wounds treated with sham units (mean decrease=16.0%, SD=8.9%, range=-30.3%-83.7%). DISCUSSION AND CONCLUSION: The results of the study indicate that HVPC administered 3 times a week should be considered to accelerate wound closure of chronic leg ulcers.

The relative roles of aggressive wound care versus revascularization in salvage of the threatened lower extremity in the renal failure diabetic patient.

Current literature indicates poor survival and limb salvage rates in renal failure diabetic patients who present with ulcerated or gangrenous lower extremities. Even in those limbs that were successfully revascularized, the amputation rate was as high as 37 percent. This has led some to advocate immediate amputation when treating the threatened limb of a renal failure diabetic patient. The authors reviewed all renal failure diabetic patients in their wound registry to determine whether such pessimism was warranted. The authors then analyzed the relative roles of revascularization and aggressive wound care on long-term limb salvage. Forty-five consecutive renal failure diabetic patients with 71 wounds in 54 limbs were identified. Twenty-seven patients had chronic renal insufficiency, 15 patients had end-stage renal disease, and three patients received kidney transplants. The revascularization procedures (46 percent of all limbs) included angioplasty, femoral-popliteal, femoral-distal, and popliteal-distal bypasses. Forty-three amputations in combination with 67 soft-tissue repairs (delayed primary wound closure, skin grafts, local flaps, pedicled flaps, and free flaps) were necessary to close the defects. After a mean follow-up of over 3 years, the data indicate that 79 percent of wounds healed, 89 percent of all limbs were salvaged, and 49 percent of patients survived. Revascularization improved the threatened limb's salvage rate from negligible to a level similar to that of the adequately vascularized limb. Fifteen out of 71 wounds did not heal because of the patient's early postoperative death, ischemia not amenable to revascularization, or noncompliance. Six below-knee amputations were performed (one despite a patent bypass and five in adequately vascularized patients). The average time for wounds to heal in the revascularized patients was 79 days versus 71 days in adequately vascularized patients. There was an overall 43 percent complication rate. Of the patients who were alive after the 3-year follow-up, 73 percent were independently ambulating, whereas 27 percent were bound to wheelchair or bed. Eighty-two percent of patients were very satisfied with the salvage attempt, 18 percent were moderately satisfied, and all patients said they would go through the process again. The authors believe that salvaging the threatened extremity in the renal failure diabetic patient is justified whether or not the limb requires revascularization. Revascularization improved the limb salvage rate, patient survival, and days for wounds to heal to a level comparable to that of the adequately vascularized limb. The key to subsequently achieving high salvage rates is the quality of perioperative wound care (e.g., serial debridements, antibiotics, dressings) and the timing and selection of appropriate soft-tissue coverage.

Randomized clinical trial comparing the efficacy of two bandaging regimens in the treatment of venous leg ulcers.

BACKGROUND: Many venous ulcers are healed by the application of external compression. It has been suggested that bandages capable of producing greater compression enhance healing. The aim of this study was to compare the time to total healing of venous ulcers in two groups of patients treated with different compression regimens in a randomized prospective trial. METHODS: A total of 112 patients was studied and all were treated with a zinc-impregnated paste bandage applied directly to the ulcer. Fifty-seven patients had the paste covered by Tensopress and 55 by Elastocrepe bandages. Both groups had a tubular bandage applied over the top to retain the bandage in place. All ulcers were stratified and randomized within one of three size groups. The 'venous' aetiology of the ulcer was confirmed on completion by calf pump function tests. RESULTS: By 26 weeks, 58 per cent of the patients treated with Tensopress and 62 per cent of those treated with Elastocrepe bandages were healed. The median healing times were 9 and 9.5 weeks respectively. Similar numbers of patients were excluded or withdrawn from both groups. Large ulcers healed significantly more slowly than small ulcers. CONCLUSION: There was no significant improvement in venous ulcer healing using higher compression elastic bandages.

Techniques for covering soft tissue defects resulting from plantar ulcers in leprosy: Part IV - use of medial leg flap and medial knee flap

The medial leg flap, based on the cutaneous branches of the posterior tibial artery is raised from the middle and lower regions of the medial aspect of the leg. It has a long pedicle, and it can be used as a free flap to reconstruct the distant soft tissue and also as an island flap. We have used this retrograde island flap for a surfacing ulcerated areas in six leprosy patients. The flap survived in all cases. At 24 to 60 months follow up examination, ulceration had not recurred in any for them. The medial knee flap consisting of the skin and subcutaneous tissu of lower part of the medial side of the thih and upper part the leg, is suitable for covering soft tissue cushion defects of the extremities because of the constant vessels, long pedicle, wide diameter, well recognizable sensory nerves and less subcutaneous fat. We have used the medial knee flap for the resurfacing sizeable raw areas due to ulceration in there leprosy patients. the flap survived in all cases there was no recurrence of ulceration duriong the 70-148 months follow up period

Living with chronic venous leg ulcers: a descriptive study of knowledge and functional health status.

A descriptive design was used to identify the functional health status and knowledge level of individuals living at home with chronic venous leg ulcers (N = 21). Limitations in physical function and vitality were moderate to severe, impacting on study participants' productive activities and activities of daily living. Severe to moderate pain was experienced by 19% of the participants. In addition, knowledge deficits were apparent regarding the cause and treatment of leg ulcers. Findings of this study suggest the importance of assessing these factors in addition to the wound when caring for individuals in the community with chronic venous leg ulcers.

The role of physiotherapy in managing patients with wounds.

The physiotherapist is a highly respected member of the wound-care team in the USA. While assisting in all aspects of wound care, including debridement and dressing selection and application, the physiotherapist also provides a unique function. The numerous physical agents, such as electrical stimulation, ultrasound, hydrotherapy and heat all have benefits to offer the patient in contributing to healing. The background knowledge of biomechanics possessed by members of this discipline likewise enhances the services of the wound-care team. Physiotherapists recommend strategies to relieve or redistribute pressure for those confined to bed or wheelchair or for the ambulatory individual with an insensate foot. It is perceived that physiotherapists who remain uninvolved in wound care are a major untapped resource with great potential for promoting wound healing.

Subfascial endoscopic perforator surgery is associated with significantly less morbidity and shorter hospital stay than open operation (Linton's procedure)

BACKGROUND: Subfascial endoscopic perforator surgery (SEPS) is the minimally invasive alternative to the open (Linton's) procedure. This new technique may allow perforating vein interruption with fewer complications and a shorter postoperative hospital stay. METHODS: This study was a case note review of 67 procedures: 30 SEPS and 37 Linton's. RESULTS: There were no significant differences between the two groups in age, sex and indication for surgery. SEPS was associated with a significantly reduced postoperative stay in hospital (median 2 (range 1-49) days) compared with the Linton's procedure (median 9 (range 3-36) days) (P < 0.01). Nine patients who had Linton's procedure suffered a calf wound complication compared with none who had SEPS. The presence of an open ulcer at the time of surgery did not prolong the duration of stay in either group, nor did it increase the incidence of calf wound complications. CONCLUSION: In patients undergoing calf perforator interruption for chronic venous insufficiency, SEPS is associated with significantly less morbidity and a shorter hospital stay than Linton's procedure. SEPS can be performed safely at the same time as skin grafting and in the presence of an open ulcer without any increase in wound complications.