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Bilayered bioengineered skin substitute (Apligraf): a review of its use in the treatment of venous leg ulcers and diabetic foot ulcers.

UNLABELLED: The bilayered bioengineered skin substitute (BBSS) [Apligraf] is used for the treatment of venous leg ulcers and diabetic foot ulcers. It has an epidermal layer formed from human keratinocytes and a dermal layer composed of human fibroblasts in a bovine type I collagen matrix. BBSS does not contain any antigen-presenting cells such as Langerhans cells, dermal dendritic cells, endothelial cells or leucocytes. In clinical trials, there was no evidence of clinical rejection and immunological tests indicated no humoral or cellular response to the keratinocytes or fibroblasts of BBSS. Further clinical trials are required to identify the exact mechanism of action of BBSS in chronic wounds. BBSS plus compression therapy was well tolerated and was superior in efficacy to compression therapy alone in a multicentre, randomised trial in patients with venous leg ulcers. At 6 months' follow-up, complete wound healing occurred in 63 versus 49% of patients and the median time to wound closure was 61 versus 181 days. In a subgroup of patients with hard-to-heal ulcers (>1 year's duration), wound healing was achieved in significantly more patients (47 vs 19%) and the median time to wound healing was significantly shorter (181 days vs not attained). In a multicentre, randomised trial, BBSS was well tolerated and effective in patients with full-thickness neuropathic diabetic foot ulcers. Ulcer healing occurred in significantly more patients (56 vs 38%) and the median time to wound healing was shorter (65 vs 90 days) with BBSS than with saline-moistened gauze at 12 weeks' follow-up. Patients in both groups also received standard diabetic foot care. The cost effectiveness of BBSS in patients with chronic ulcers has yet to be examined in well designed, prospective clinical trials. However, according to a modelled analysis incorporating data from a multicentre randomised trial, BBSS was cost effective in patients with hard-to-heal venous leg ulcers. The average annual medical cost of managing patients with ulcers of >1 year's duration was estimated to be 20,041 US dollars per patient treated with BBSS plus compression therapy and 27,493 US dollars per patient treated with compression therapy alone (1996 costs). CONCLUSIONS: Clinical trials have shown that BBSS in conjunction with standard compression therapy was effective and well tolerated in patients with venous leg ulcers, especially patients with ulcers of >6 months' duration or that extended to the subcutaneous tissue. In addition, BBSS in conjunction with standard diabetic foot care was effective and well tolerated in patients with full-thickness neuropathic diabetic foot ulcers. BBSS represents a useful adjuvant to standard ulcer therapy in patients with venous leg ulcers or full-thickness neuropathic diabetic foot ulcers that do not respond to conventional ulcer therapy.

Clinical Trials as Topic↗

[Fasciocutaneous flaps in the treatment of soft tissue defects of the lower leg caused by explosive war injuries].

The use of fasciocutaneous flaps for the reconstruction of lower leg soft-tissue defects inflicted during the bombing of our country is presented in this case report. The experience with 9 patients with soft-tissue defects of the lower leg is presented with the aim of examining the possibilities of war-wound reconstruction. The results of the earlier use of fasciocutaneous flaps in the lower leg reconstruction as well as the those obtained during the reconstruction of the lower leg soft-tissue defects in war wounds was proven to be safe and reliable method of the reconstructions of severe lower leg injuries, particularly of its distal segment and the malleolus region.

Adolescent↗

[Acute leg compartment syndrome after exertion].

A case of a 22-year old soldier, with a history of pain in the leg during heavy exercise, which desisted at rest, was presented. One day before admission, the patient had felt an extreme exertion-induced pain in his right leg which had not lessenned at rest. At the same time, the patient noticed persistent severe leg edema. On physical examination, the intracompartmental pressure was 62 mmHg (> 30 mmHg). The patient was urgently operated on, and fasciotomy according to Mubarak was used. At second surgery, the debridement of the muscles of the posterior group of the leg, and the evacuation of hemathoma from the anterior and lateral group of the right leg muscles were perfomed. Postoperative recovery was uneventful. Fasciotomy wounds were closed within 14 days of the surgery. The complete physical treatment was done. Follow-up examinations 1, 3, and 6 months afterwards were satisfactory. The soldier completed his compulsory military service without any sequelae. Laboratory results were normal. Overlooked, unrecognized or surgically untreated compartment syndrome can cause severe damage, including even the loss of the extremity.

Acute Disease↗

Measurement of L-[1-14C]leucine kinetics in splanchnic and leg tissues in humans. Effect of amino acid infusion.

Although whole-body leucine flux is widely measured to study body protein turnover in humans, the contribution of specific tissues to the total-body measurement remains unknown. By combining the organ-balance technique with the systemic infusion of L-[1-14C]leucine, we quantitated leucine production and disposal by splanchnic and leg tissues and by the whole body, simultaneously, in six normal men before and during amino acid infusion. At steady state, disposal of arterial leucine by splanchnic and leg tissues was calculated from the percent extraction (E) of L-[1-14C]leucine counts: uptake = E x [Leu]a x flow. Tissue release of cold leucine (from protein turnover) into vein was calculated as the difference between leucine uptake and the net tissue leucine balance. In the postabsorptive state, despite substantial (P less than .01) extraction of L-[1-14C]leucine by splanchnic (23 +/- 1%) and leg (18 +/- 2%) tissues, net leucine balance across both tissue beds was small, indicating active simultaneous disposal and production of leucine at nearly equivalent rates. Splanchnic tissues accounted for approximately 50% of the measured total-body leucine flux. During amino acid infusion, the net leucine balance across splanchnic and leg tissues became positive, reflecting not only an increase in leucine uptake but also a marked suppression (by approximately 50%, P less than .02) of cold leucine release. This reduction in splanchnic and leg leucine release was indicated by a sharp decline in whole-body endogenous leucine flux.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Transcutaneous oxygen tension in legs and feet of diabetic patients.

Transcutaneous oxygen tension (tcPO2) of the legs and feet was measured at 37 and 44 degrees C in 21 patients with diabetes mellitus, 9 of whom had peripheral neuropathy. At 37 degrees C, tcPO2 in the legs and feet of diabetic patients with peripheral neuropathy was significantly higher (P less than .02) than in control subjects and diabetic patients without neuropathy. Whereas tcPO2 in the legs of control subjects and nonneuropathic diabetic patients was greater than in the feet (P less than .02), this leg-to-foot difference was absent in diabetic patients with neuropathy. After an increase in skin temperature to 44 degrees C, tcPO2 increased in the legs and feet of all three groups, but the increase was smallest in diabetic patients with neuropathy and greatest in control subjects. In neuropathic (P less than .02) and nonneuropathic (P less than .02) diabetic patients, tcPO2 was significantly lower than in control subjects. These data are consistent with a loss of vasoconstrictor tone in the blood vessels perfusing skin and subcutaneous tissue at 37 degrees C and an inability of these vessels to vasodilate and increase blood flow at 44 degrees C in diabetic patients in general and neuropathic diabetic patients in particular. This inability to increase tcPO2 after an increase in temperature and possibly other vasodilatory stimuli may contribute to the pathogenesis of nonhealing ulcers, protracted infections, and gangrene, which characterize the diabetic foot.

Adolescent↗

Effects of ipsilateral anterior thigh soft tissue stretching on passive unilateral straight-leg raise.

STUDY DESIGN: Randomized 3-group pretest-posttest with blind assessment of outcome. OBJECTIVES: The purpose of this study was to examine the effect of sagittal plane hold-relax exercise applied to the ipsilateral anterior thigh, and prone positioning on passive unilateral straight-leg raise measurements. BACKGROUND: Straight-leg raising has been viewed as a measurement for hamstring muscle length, but literature suggests that other structures may affect this measurement. METHODS AND MEASURES: Sixty subjects (45 men, 15 women) qualified for inclusion into the study based on a straight-leg raise measurement of < or = 65 degrees. Subjects were randomly assigned to one of three groups: control, static stretch, or sagittal plane hold-relax exercise. Pretest and posttest straight-leg raise measurements of the right lower extremity were performed for each subject. RESULTS: A 1-way ANOVA of the change scores showed a significant difference between groups. A Tukey post hoc analysis of the change scores showed that both treatment groups' means differed significantly from the control group and from each other, with the sagittal plane hold-relax group exhibiting the largest change (mean of 7.8 degrees +/- 2.8 degrees). CONCLUSIONS: The results of this study show that sagittal plane hold-relax exercise and passive prone results of this study show that sagittal plane hold-relax and passive prone positioning can significantly increase straight-leg raise range of motion, however the sagittal plane hold-relax stretching of the anterior thigh is more effective than passive prone positioning.

Adult↗

Accuracy and precision of clinical estimation of leg length inequality and lumbar scoliosis: comparison of clinical and radiological measurements.

The results of 196 clinical determinations of leg length inequality and postural pelvic tilt scoliosis in 21 patients were analysed and compared with reliable radiological measurements. Clinical methods proved to be inaccurate and highly imprecise, the observer error being +/- 8.6 mm for direct and +/- 7.5 mm for indirect measurement of leg length inequality, and +/- 6.4 degrees for the estimation of postural lumbar scoliosis. More than half (53%) of the observations were erroneous when the criterion of leg length inequality was 5 mm. Failure to determine the presence or absence of length inequality of more than 5 mm occurred in 54 measurements (27% of the total). In 12% of the direct and in 13% of the indirect measurements, the observers erred in deciding which leg was longer; discrepancies occurred even when radiological reading gave a leg length inequality of as much as 25 mm.

Adult↗

Effects of high intensity step-up and low intensity step-down lighting programs on the incidence of leg abnormalities in turkeys.

Two trials were conducted to determine if a high intensity (20 lx) step-up lighting program would decrease the incidence of leg abnormalities in turkeys. The step-up lighting regimen was compared to a low intensity (2.5 lx) step-down lighting program. Toms were used in Trial 1 and both sexes were employed in Trial 2. Body weight, feed/gain ratio, and mortality of toms of Trial 1 did not differ significantly between lighting regimens. The incidence of leg deformities and the length of the tarsometatarsal bone were significantly decreased, whereas plasma androgen and testes weights were increased for toms of Trial 1 in the high intensity step-up lighting. The same trends were apparent for toms of Trial 2 with the exceptions that feed/gain ratios were adversely affected and testes weights were significantly lower for toms of the high intensity step-up lighting program. The performance of hens in the high intensity step-up lighting program of Trial 2 was affected adversely; however, incidence of leg abnormalities and length and width of the tarsometatarsus responded in the same manner as with toms. The results of this study indicate that a high intensity step-up lighting program can significantly reduce leg weakness problems in turkeys. Possible explanations for light stimulation reducing the incidence of leg abnormalities are through increased exercise and shortening of long bones.

Animals↗

Leg length equalization during total hip replacement.

A method of equalization of leg lengths during total hip replacement surgery was developed which utilizes the concept of equalizing the vertical dimensions of the resected femoral head and neck segment and the remaining hip joint cartilage space, which are removed during the procedure, with the vertical dimensions of the femoral and acetabular prostheses, which are implanted into that void. This was accomplished by determining the dimensions of the prostheses from careful preoperative templating technique and by using a simple arithmetic formula to determine the level of the femoral neck osteotomy. The level of the osteotomy was made by a measurement from the top of the dislocated head of the femur to the medial femoral neck calcar. The radiologic postoperative leg length differences of a consecutive series of 84 patients undergoing primary total hip replacement using this method were determined. The average discrepancy was 2.8 mm. Seventy-five patients (89%) were found to have a postoperative leg length discrepancy of 6 mm (1/4 inch) or less. Six patients (7%) had a discrepancy of 7 to 13 mm, and only three patients (4%) had more than 13 mm (1/2 inch) leg length difference. Using this technique only two patients (2.5%) with unilateral hip replacements had leg lengthening of more than 6 mm.

Anthropometry↗

The swollen leg: is it deep vein thrombosis? The experience of a tertiary referral center in Sri Lanka.

INTRODUCTION: The role played by deep vein thrombosis (DVT) as a cause of leg swelling in Sri Lanka is unknown. PURPOSE: To study the prevalence of proximal DVT, value of risk factors and clinical features and attitudes of clinicians towards diagnosis and treatment of DVT among those presenting with leg swelling as the main complaint. DESIGN: Prospective consecutive referrals to the University Surgical Unit, Colombo, over 10 months starting in January 1998. INCLUSION CRITERIA: DVT suspects with swollen legs. EXCLUSION CRITERIA: Varicose veins, leg ulceration and generalized oedema. METHODS: Color duplex scanning of the proximal deep veins and the superficial veins to detect occlusion and reflux. Information on previous diagnoses and treatment were obtained from the medical records. RESULTS: 63/137 (45%) had deep venous causes for oedema. Fever with rigors and inguinal lymphaedenopathy were strongly predictive of non DVT causes. Filariasis is the first diagnosis and DVT is considered late among the outpatients. CONCLUSIONS: DVT is a common cause of leg swelling among those referred.

Edema↗

[Usefulness of lower extremity 2D TOF MR venography with respiratory compensation technique, and effect of patient positioning on the visualization of deep veins in the leg].

We evaluated the usefulness of two-dimensional time-of-flight (2D TOF) MR venography (MRV) of the lower extremity using the respiratory compensation (RC) technique. In addition, six variations in patient positioning of the leg and knee were investigated to determine the best method of visualizing the deep popliteal veins and lower leg. All data sets were reviewed and graded for visualization of the deep veins at the pelvis, thigh, and leg portion (4-point scale) by two radiologists and three radiological technologists. The same veins demonstrated with various positions of the patient were also evaluated in the same manner. In conclusion, 2D TOF MRV with RC resulted in increased uniformity of vein signal in the pelvic area. Furthermore, we should position the patient's leg so as not to compress the vein at the posterior portion of the leg, and not to over-extend the knee joint. This enabled the best results to be obtained in MRV of the lower extremity.

Adult↗

Relationship of functional leg-length discrepancy to abnormal pronation.

The objective of this study was to determine whether a correlation exists between abnormal pronation and functional leg-length discrepancies. Visual assessment and a pelvic thrust maneuver were used to identify the functionally short leg in 56 indigenous Mexicans (20 males and 36 females; mean age, 33 years; mean weight, 59 kg; and mean height, 1.60 m). The Foot Posture Index was used with a modified stance position to identify the more pronated foot. The posterosuperior iliac spines were used to identify the "relative" position of the innominate bones. The raw data obtained from this study were evaluated using the McNemar test for paired proportions. A significant positive correlation was found between abnormal pronation and hip position and between hip position and functional leg-length discrepancy. These results are consistent with a theoretical ascending dysfunctional pelvic model: Abnormal pronation pulls the innominate bones anteriorly (forward); anterior rotation of the innominate bones shifts the acetabula posteriorly and cephalad (backward and upward); and this shift in the acetabula hyperextends the knees and shortens the legs, with the shortest leg corresponding to the most pronated foot.

Adolescent↗

Incidence of sacroiliac joint malalignment in leg length discrepancies.

The purpose of this study was to ascertain the incidence of leg length discrepancies in a sample of asymptomatic female college students, and then to determine the incidence of sacroiliac joint malalignment within that same sample. Structural leg length, functional leg length, and sacroiliac position were determined for each subject. The results indicate a high incidence of leg length discrepancies within the sample, and also a fairly high incidence of asymptomatic sacroiliac joint malalignment when leg length discrepancies are present.

Adult↗

[Detection of venous occlusions of the leg and pelvis by means of nuclear medicine].

Based upon experience with 563 patients, the 131 I fibrinogen test has proven a reliable method for the diagnosis of acute leg vein thrombosis. Investigations correlated by means of roentgenological phlebography performed by routine technique in 83 patients showed similar results in 77% of the cases. Analyzing the negative results of 23%, we consider 19% of the discrepancies to be due to faulty phlebographic and 4% to faulty fibrinogen results. Phlebography may reveal false positive results in recurrent thromboses and false negative results in thrombosis of the lower legs. The fibrinogen test may reveal false positive results after trauma, fractures, and in cases of superficial phlebitis and arthritis. Pelvic venous occlusions are detectable by radionuclid venography. This method is non-invasive (injection of 99m Tc albumin particels or microspheres in less than 1 ml, by means of a very thin needle into a dorsal foot vein). A lung scan is obtained in every examination. The results conformed in 89% of 250 patients with those obtained from Doppler ultrasonic investigations. Two thirds of all pelvic vein thromboses were located on the left side. Perfusion defects of the lungs were probably caused by pulmonary embolism (lung scanning) and were found in an average of 54% of all leg and pelvic vein thromboses (in thrombosis of the lower legs in 35%, of the thigh in 57% and of the pelvic vein in 70%). These figures are in good conformity with pathological-anatomical data concerning the frequency of pulmonary emboli and infarctions in leg and pelvic vein thrombosis.

Adult↗

Prevalence of leg wound complications after coronary artery bypass grafting: determination of risk factors.

BACKGROUND: The reported prevalence of leg wound complications after coronary artery bypass grafting is 2% to 24%. Decreased length of hospital stay for patients who have this surgical procedure poses new care requirements in both acute care and community settings. OBJECTIVE: To determine the prevalence of postoperative leg wound complications in patients undergoing coronary artery bypass grafting and the risk factors associated with these complications. METHOD: In this prospective, observational study, 547 consecutive patients who had coronary artery bypass grafting alone or in combination with other cardiac surgical procedures were examined for evidence of leg wound complications each day after surgery during hospitalization. After discharge, problems were detected by home care nurses. RESULTS: The prevalence of leg wound complications was 6.8%. Factors significant by multiple logistic regression included preoperative hospitalization, use of an Ace elastic bandage in the operating room, the length of time the leg incision remained open in the operating room, and administration of nicardipine intravenously in the intensive care unit. Odds ratios were calculated for each variable. Premorbid factors such as diabetes or peripheral vascular disease were not predictive of complications. On average, most problems occurred on postoperative day 10, when many patients were at home. CONCLUSIONS: The results highlight the need to detect complications early, in both the hospital and the community settings. The determination of factors related to poor outcomes may assist clinicians in improving healthcare delivery.

Aged↗

[Leg ulcers. Allergologic studies of 359 cases].

INTRODUCTION: Leg ulcers are a common disease in dermatology. Their social and economic implications are important, especially when contact dermatitis complicates these wounds. PATIENTS AND METHODS: In this study a total of 359 patients had contact dermatitis investigations over a period of 5 years. Patch-tests were performed on 116 men and 243 women hospitalized with venous and/or arterial leg ulcers, with or without clinical appearance of periulcerous contact dermatitis. Standard patch-tests of the ICDRG (International Contact Dermatitis Research Group) were systematically performed as well as a specific series of 40 tests. RESULTS AND DISCUSSION: Positive patch tests were observed in 82.5 p. 100 of the patients, indicating a very high rate of contact allergy in patients with leg ulcers. Peru balsam, lanolin and neomycin were the most frequent culprits of positive patch-tests in this population. Five percent of patch-tests with eosin were positive in our study. This is not common in the literature. Moreover, we highlight the high rate of contact sensitization to corticosteroids in this population. According to these results and to the literature, a new series of patch-tests for leg ulcers is suggested. CONCLUSION: Polysensitization in patients with chronic wounds is very frequent. A series of patch-tests in leg ulcers may lead to some interesting conclusions but a good questioning of the patient is always necessary to complete this series.

Adult↗

Anaerobic power of the arms and legs of young and older men.

The purpose of this study was to examine differences in the anaerobic exercise performance of young and older men. Eight healthy, active older (68.5 +/- 2.4 years old, mean S.D.) and eight healthy, active young (30.6 +/- 4.5 years old) subjects were assessed for peak and mean power output (PP and MP, respectively) of the legs and arms, during 30 s Wingate tests. PP during leg exercise was significantly (P < 0.05) higher in the young (14.6 +/- 1.6 W kg-1) compared with the older (10.7 +/- 1.0 W kg-1) group. MP of the legs was also greater in the young subjects (10.7 +/- 0.7 vs. 7.4 +/- 0.9 W kg-1). These differences in PP and MP remained significant when expressed relative to lean leg volume. PP during arm cranking was significantly greater in the young subjects (8.9 +/- 0.7 vs. 7.5 +/- 0.6 W kg-1) as was MP (6.4 +/- 0.7 vs. 5.0 +/- 0.7 W kg-1). Post-exercise blood lactate concentration in the older group (7.0 +/- 1.6 mmol l-1) was less (P < 0.05) than in the young group (10.6 +/- 2.0 mmol l-1), for leg work only. The significant loss of anaerobic power in the older group could not be explained by a difference in muscle mass. Power output was also lower in the arms, but to a lesser extent. The results of this study suggest that a reduction in the ability to perform high intensity exercise may be an inevitable consequence of ageing. The extent, however, of this decline varies with different muscle groups.

Adult↗

[Ambulatory skin grafting in leg ulcers: a feasibility study of 34 patients].

OBJECTIVES: Despite the advent of modern dressings, management of leg ulcers remains a long costly process, particularly if no etiological treatment is possible. Autologous skin grafting is more and more widely used in this indication. The aim of this open single center noncomparative study was to analyze the feasibility of ambulatory procedures for skin grafting and the incidence of ambulatory care in a medical nursing clinic as an alternative to traditional hospitalization on total cost in this pathological condition. PATIENTS AND METHODS: Thirty-nine grafts were performed in 34 consecutive patients. No selection was made for etiology or duration of the leg ulcers. Three grafting techniques were used after debridement-cleansing: flap grafts for medium sized ulcers (29 cases), mesh grafts for large ulcers (6 cases) and patch grafts for small ulcers or ulcers with irregular contours (4 cases). The dressing was opened on day 5, nursing care was provided every 2 days and daily in case of infection. Percentage of healing was evaluated clinically on days 5, 15 and 30 then at months 3, 6 and 12. Photographs were taken. RESULTS: Four patients were lost to follow-up and one died. Among the 34 grafts assessed at 6 months, we obtained total healing in 56 p. 100, 75 p. 100 healing in 6 p. 100, 50 p. 100 healing in 9 p. 100 and failure in 29 p. 100. Healing rates were those expected for arterial ulcers and necrotic angiodermas. For venous leg ulcers, the rate of total healing was only 30 p. 100 at 6 months and 43 p. 100 at 1 year. Outcome depended on duration of the lesion and not on the type of skin graft or patient age. DISCUSSION: This prospective study reports outcome of ambulatory skin grafting in a large representative sample of patients with leg ulcers of various etiologies. The less favorable outcome for venous ulcers can be explained by the duration of the ulcerations and infection in these often neglected lesions. The risk of graft displacement, contact eczema, and infection must be recognized for early treatment. There were no cases with general complications. This ambulatory technique has the enormous advantage of limiting the risk of hospital-related problems in this elderly population and of reducing overall cost of care for leg ulcers, and finally of limiting the risk of recurrence by regular post-graft follow-up in a specialized center and by treatment of the causal disease.

Aged↗