Negative pressure wound therapy with instillation and dwell time in debridement of fibrinous leg ulcers.

OBJECTIVE: In conjunction with appropriate wound care, negative pressure wound therapy with instillation and dwell time (NPWTi-d) may be used as an adjunct therapy for acute or hard-to-heal (chronic) wounds, especially when infected. However, there are very few data on the use of NPWTi-d in the treatment of fibrinous wounds that are difficult to debride mechanically. The main objective of this study was to describe changes in the fibrin area of such wounds, before and after treatment with NPWTi-d. METHOD: This was a monocentric, observational, prospective pilot study evaluating the NPWTi-d medical device. Eligible patients included in the study were those with hard-to-heal lower limb ulcers who had previously undergone unsuccessful specific debridement treatment for their wound, with failure of manual mechanic debridement for at least six weeks' duration, and whose wounds had a fibrinous surface area of >70% of the total wound surface area. The primary endpoint was the difference in the percentage of fibrinous surface area before and after treatment. RESULTS: A total of 14 patients who received treatment for lower limb ulcers between October 2017 and August 2019 were included in the study. There was a significant shrinkage rate of the fibrinous wound surface between the start and end of treatment (83.6±14.5% and 32.2±19.7%, respectively; p<0.001). CONCLUSION: This study showed a significant decrease in fibrin area in wounds treated with NPWTi-d, with good tolerance. We believe that NPWTi-d has its place in the multidisciplinary management of patients with hard-to-heal ulcers. Additional randomised studies are required to confirm these findings. DECLARATION OF INTEREST: The authors have no conflicts of interest.

Localised intravascular coagulation complicating venous malformations: Clinical characterisation.

OBJECTIVE: The International Union of Phlebology recommends measuring at least D-dimer and fibrinogen levels in the diagnosis of extensive extra-truncular venous malformations, with a surface area of 10 cm2 or those which are deep, as well as prior to any interventional procedure. The aim of the study was to characterise venous malformations associated with a possible vascular complication. METHOD: This study was an observational and multicentre study. The objective was to explore the presence of a possible coagulation disorder among patients with venous malformation. The primary endpoint was to characterise venous malformations with increased D-dimer levels. RESULTS: The majority of the 72 venous malformations were located in the trunk region, mostly in intramuscular or subcutaneous locations. There were 72 venous malformations with increased D-dimer levels including 3 with biological disseminated intravascular coagulation (elevated D-dimer and fibrinogen <1 g/L). The anticoagulant treatments administered were very heterogeneous in class and dosage, and at the end of the treatment, 17 elevated D-dimers were persistent, 9 venous malformations remained painful and 27 showed thrombotic regression. CONCLUSION: Venous vascular malformations are probably underestimated and should probably be explored more systematically in terms of coagulation disorder regardless of size or symptomatology. The therapeutic recommendations to treat localised intravascular coagulation with low-molecular weight are not widely applied. Studies are needed, in particular to assess the role of oral anticoagulants in the management of coagulation disorder among patients with venous malformation.

Digital pressure with laser Doppler flowmetry is better than photoplethysmography to characterize peripheral arterial disease of the upper limbs in end-stage renal disease patients.

OBJECTIVE: There is no consensual definition of significant peripheral arterial disease of the upper limbs. Patients with end-stage renal disease are usually explored with Doppler ultrasound, which seems insufficient to characterize and quantify the arterial disease in this anatomic site. Candidates for haemodialysis access tend to be increasingly older and have polyvascular disease, and a better assessment of the vascular status of their upper limbs with finger systolic blood pressure is necessary. Photoplethysmography is simple and currently used in practice, but laser Doppler flowmetry may be more sensitive for low values. Our objective is to investigate additional information in the digit assessment over the ultrasound assessment of the upper limbs of patients awaiting haemodialysis and compare digital pressure values taken by photoplethysmography and laser Doppler. METHODS: All included patients with end-stage renal disease scheduled for haemodialysis access received a prospective evaluation of their upper limbs with a clinical examination of the hands, an arterial upper limb Doppler ultrasound, and finger systolic blood pressure using photoplethysmography and laser Doppler flowmetry. Significant upper limb arterial disease was defined by a finger systolic blood pressure below 60 mm Hg or a finger brachial pressure index below 0.7. RESULTS: Twenty-four patients were included in the study. In all, 41.7% of patients (n = 10) had parietal calcifications to the antebrachial arteries on Doppler ultrasound, 8.3% of patients (n = 2) had bilateral finger systolic blood pressure values below 60 mm Hg with laser Doppler flowmetry (but not confirmed with photoplethysmography), and 16.6% of patients (n = 4) had a finger brachial pressure index below 0.7 on both laser Doppler flowmetry and photoplethysmography. While there was an agreement between these two methods, higher values were recorded with photoplethysmography. The Pearson coefficient was 0.493 for the median of basal digital pressures in absolute values and 0.489 for finger brachial pressure index (p < 0.001). CONCLUSION: Our study confirms the need to evaluate significant upper limb arterial disease in patients with end-stage renal disease not only with Doppler ultrasound but also with an evaluation of the finger systolic blood pressure. The correlation of the finger systolic blood pressure values using laser Doppler flowmetry and photoplethysmography was poor, which was probably due to an overestimation of the pressures with photoplethysmography. Despite the absence of a gold standard, we suggest that Laser Doppler flowmetry should be used rather than photoplethysmography to better characterize significant peripheral arterial disease of the upper limbs in patients with end-stage renal disease, particularly before creation of a new haemodialysis access. Protocol Record on clinical trial 38RC19.285.

The European/International Fibromuscular Dysplasia Registry and Initiative (FEIRI)-clinical phenotypes and their predictors based on a cohort of 1000 patients.

AIMS: Since December 2015, the European/International Fibromuscular Dysplasia (FMD) Registry enrolled 1022 patients from 22 countries. We present their characteristics according to disease subtype, age and gender, as well as predictors of widespread disease, aneurysms and dissections. METHODS AND RESULTS: All patients diagnosed with FMD (string-of-beads or focal stenosis in at least one vascular bed) based on computed tomography angiography, magnetic resonance angiography, and/or catheter-based angiography were eligible. Patients were predominantly women (82%) and Caucasians (88%). Age at diagnosis was 46 ± 16 years (12% ≥65 years old), 86% were hypertensive, 72% had multifocal, and 57% multivessel FMD. Compared to patients with multifocal FMD, patients with focal FMD were younger, more often men, had less often multivessel FMD but more revascularizations. Compared to women with FMD, men were younger, had more often focal FMD and arterial dissections. Compared to younger patients with FMD, patients ≥65 years old had more often multifocal FMD, lower estimated glomerular filtration rate and more atherosclerotic lesions. Independent predictors of multivessel FMD were age at FMD diagnosis, stroke, multifocal subtype, presence of aneurysm or dissection, and family history of FMD. Predictors of aneurysms were multivessel and multifocal FMD. Predictors of dissections were age at FMD diagnosis, male gender, stroke, and multivessel FMD. CONCLUSIONS: The European/International FMD Registry allowed large-scale characterization of distinct profiles of patients with FMD and, more importantly, identification of a unique set of independent predictors of widespread disease, aneurysms and dissections, paving the way for targeted screening, management, and follow-up of FMD.

Fluorescence angiography compared to toe blood pressure in the evaluation of severe limb ischemia.

Background: Severity of limb ischemia in peripheral arterial disease (PAD) patients is usually evaluated by clinical assessment and toe blood pressure (TBP) or transcutaneous oxygen pressures (TcPO 2). Indocyanin green angiography (IGA) is a promising tool generating a foot cartography of skin microvascular perfusion. However, there is no consensus about the fluorescence parameters that should be used to evaluate ischemia. The purpose of this cross-sectional evaluation and 3-month clinical follow-up was to determine the best fluorescence parameter for the evaluation of severe PAD, using TBP as reference. Patients and methods: IGA was realized in patients with clinical suspicion of CLI in addition to TBP and TcPO 2. Parameters from the time intensity fluorescence curve measured on the foot were compared with TBP (primary reference), and with TcPO2. Clinical outcomes (amputation, revascularization, death) were recorded at 3 months follow-up. Results: Thirty-four patients were included and IGA could be analysed in 29 of them. When all limbs were studied, no significant correlation was found between any of the measured fluorescence parameters (saturation time, ingress slope, amplitude, delay) and TBP pressure neither TCPO2. In the limbs with CLI, a significant correlation between the TBP and amplitude on the forefoot was found. According to the outcome, none of the fluorescence parameters showed a significant prognostic value in contrast to the significant results for TBP and TcPO2. Conclusions: In this study, quantitative analysis of IGA parameters did not show any prognostic value, nor was there any significant statistical association with well-established prognostic parameters such as TBP and TcPO 2 in patients with suspected CLI. A correlation was found between amplitude and TBP in patients with CLI. Topographical information such as perfusion heterogeneity was not evaluated and remains a valuable target to be investigated.

Endovascular Treatment of Post-thrombotic Venous Ilio-Femoral Occlusions: Prognostic Value of Venous Lesions Caudal to the Common Femoral Vein.

OBJECTIVES: To propose a scale of severity for post-thrombotic venous lesions (PTVLs) after ilio-femoral deep venous thrombosis and to compare the grade with the results of endovascular treatment of ilio-femoral PTVLs. METHODS: In this retrospective monocentric observational study, we included 95 patients treated for ilio-femoral PTVLs. We proposed a four-grade scale evaluating the severity of PTVLS caudal to the common femoral vein based on CT phlebography and per-operative phlebography. For most patients, venous patency was assessed with color duplex ultrasonography and the clinical efficacy of the intervention using the Villalta and CIVIQ scores. RESULTS: Recanalization was successful in 100% of patients with a morbidity rate of 4%. After a mean follow-up of 21 months, the overall primary patency was 75%, the assisted primary patency 82%, and the secondary patency 93%. Secondary patency was 100% for grade 0-1, 90% for grade 2, and 63% for grade 3 (p < 0.002). There was no correlation between the extension of stenting caudally of the common femoral vein and venous patency. The mean improvements in the Villalta and CIVIQ-20 scores were, respectively, 4.6 (p < 0.0001) and 18 (p < 0.0001); scores were not correlated with the grade of PTVLs in the thigh. CONCLUSION: Venous patency after endovascular treatment of ilio-femoral PTVLs was strongly linked to the severity of PTVLs caudal to the common femoral vein but not to the extent of stenting.

Autologous haematopoietic stem cell transplantation (AHSCT) in autoimmune disease adult patients in France: analysis of the long-term outcome from the French Society for Bone Marrow Transplantation and Cellular Therapy (SFGM-TC).

INTRODUCTION: The use of autologous haematopoietic stem cell transplantation (AHSCT) in autoimmune disease (AD) patients has increased progressively worldwide. We retrospectively analysed the long-term outcome of AHSCT for AD reported to the French Society for Bone Marrow Transplantation and Cellular Therapy (SFGM-TC). METHOD: All French AD patients (≥ 18 years at transplant) with a first AHSCT between 1997 and 2013 were included. Primary data were derived from the European Society for Blood and Marrow Transplantation (EBMT) registry, and additional data were obtained through a specific questionnaire designed for the study. Primary end-point was overall survival (OS). Secondary end points were progression-free survival (PFS) and non-relapse mortality (NRM). RESULTS: Ninety-four AD patients were included, of whom 71% suffered from rheumatologic diseases (n = 67, including 56 systemic sclerosis (SSc)), 16% from neurological disease (n = 15, including 14 multiple sclerosis (MS)) and 13% from various other AD (n = 12). After a median (interquartile range, IQR) follow-up of 83 months (38-130), OS at 5 and 10 years were 77% (95% CI 68.5-86.2) and 64% (95% CI 51.7-76.3), and for PFS 51% (95% CI 40.4-61.6) and 44% (95% CI 32.8-55.3), respectively. Overall, NRM was 8.7% (95% CI 4.0-15.5) at day 100, 9.8% (95% CI 4.8-16.9) at 5 years and 13.6% (95% CI 6.9-22.5) at 10 years. CONCLUSIONS: This first SFGM-TC retrospective report shows long-term benefit of AHSCT in AD patients with acceptable toxicity.

On-Demand Sildenafil as a Treatment for Raynaud Phenomenon: A Series of n-of-1 Trials.

Background: Treatment of Raynaud phenomenon (RP) with phosphodiesterase-5 inhibitors has shown moderate efficacy. Adverse effects decrease the risk-benefit profile of these drugs, and patients may not be willing to receive long-term treatment. On-demand single doses before or during exposure to cold may be a good alternative. Objective: To assess the efficacy and safety of on-demand sildenafil in RP. Design: Series of randomized, double-blind, n-of-1 trials. (ClinicalTrials.gov: NCT02050360). Setting: Outpatients at a French university hospital. Participants: Patients with primary or secondary RP. Intervention: Each trial consisted of a multiple crossover study in a single patient. Repeated blocks of 3 periods of on-demand treatment were evaluated: 1 week of placebo, 1 week of sildenafil at 40 mg per dose, and 1 week of sildenafil at 80 mg per dose, with a maximum of 2 doses daily. Measurements: Raynaud Condition Score (RCS) and frequency and daily duration of attacks. Skin blood flow in response to cooling also was assessed with laser speckle contrast imaging. Mixed-effects models were used and parameters were estimated in a Bayesian framework to determine individual and aggregated efficacy. Results: 38 patients completed 2 to 5 treatment blocks. On the basis of aggregated data, the probability that sildenafil at 40 mg or 80 mg was more effective than placebo was greater than 90% for all outcomes (except for RCS with sildenafil, 80 mg). However, the aggregated effect size was not clinically relevant. Yet, substantial heterogeneity in sildenafil's efficacy was observed among participants, with clinically relevant efficacy in some patients. Limitation: The response to sildenafil was substantially heterogeneous among patients. Conclusion: Despite a high probability that sildenafil is superior to placebo, substantial heterogeneity was observed in patient response and aggregated results did not show that on-demand sildenafil has clinically relevant efficacy. In this context, the use of n-of-1 trials may be an original and relevant approach in RP. Primary Funding Source: GIRCI (Groupement Interrégional de Recherche Clinique et d'Innovation) Auvergne Rhône-Alpes (academic funding) and Pfizer.

Prevalence and severity of peripheral arterial disease among patient with heel pressure ulcer: a retrospective study of 42 patients.

Heel pressure ulcer is a major complication in elderly hospitalized patients. The association with peripheral arterial disease (PAD) which is also a frequent disease in this population is poorly known. The aim of this study was to assess the prevalence of PAD and critical limb ischemia (CLI) in patients with heel pressure ulcer. Patients referred to the vascular medicine department for heel pressure ulcer from October 2014 to June 2015 were included in the study. The assessment of peripheral arterial disease was made with the results of ankle brachial index and/or doppler ultra sound of lower limb arteries. Toe systolic pressure and transcutaneous pressure (TcPO2) were also recorded, and the diagnosis of critical limb ischemia was made according to the TASC 2 criteria. The population was composed with 42 patients (women 43%, men 57%). The mean age was 81±11 years. Heel pressures ulcers were diagnosed in the following situations: lower limb fracture (31%), acute medical illness (21%), multiple chronic conditions (28%) and critical care unit hospitalization (7%). A peripheral arterial disease was present in 31 patients (73%), and a critical limb ischemia in 7 patients. For 18 patients, PAD was not known in their past medical history, and this was the case of 5 patients among those with critical limb ischemia. A revascularization was performed in 12 patients, and 5 patients undergo a lower limb amputation. 12 patients were died at 3 months. PAD is frequent among patients with heel pressure ulcer, and is often unknown. The functional and vital prognostic are poor, and the results of our study emphasize the importance of screening PAD in the evaluation of heel pressure ulcer risk.

Is contrast enhanced ultrasonography a useful tool for the evaluation of muscular microcirculation in patients with critical limb ischaemia?

BACKGROUND: Evaluation of skin microcirculation in patients with critical limb ischemia (CLI) may be achieved by the measurement of transcutaneous oxygen pressure or skin perfusion pressure, but there is no practical method available for the evaluation of muscle microcirculation. Contrast enhanced ultrasonography (CEUS) has been used to assess muscle perfusion in patients with peripheral arterial disease. We conducted a monocentric pilot study evaluating the ability of CEUS to assess the impact of arterial revascularization on the perfusion of the calf muscle in patients with CLI. PATIENTS AND METHODS: Patients with CLI (TASC II criteria) and a possibility of proximal or medial revascularization were included. In addition to TcPO2 and toe systolic blood pressure measurements, CEUS of the calf muscle was performed just before and one month after the therapeutic procedure. Parameters derived from muscular perfusion curves were evaluated in a blinded fashion and compared with the clinical outcome. RESULTS: Thirty eight patients were included (74 % men, median age 71 years, 53 % diabetics). Thirty benefited from revascularization with a clinical success rate of 70 %. Twenty three patients could benefit from analysis before and after revascularization. No significant difference was shown in time to peak (22.3 s vs 24.0 s, P = 0.61) nor in peak intensity (2.30 dB vs 1.27 db, P = 0,26), contrasting with significant improvements of TcPO2 (43 mm Hg vs 20 mm Hg, P = 0.007) and toe systolic blood pressure (54 mm Hg vs 32 mm Hg, P = 0.002). CONCLUSIONS: The evaluation of muscular microvascular perfusion by CEUS as performed in this study is not enough sensitive to change to allow a clinically relevant evaluation of the improvement in muscle microvascular perfusion in patients with CLI benefiting from revascularization procedures.

A Femoral Common Vein Aneurysm in a Patient with Neurofibromatosis Syndrome Type 1.

Neurofibromatosis type I (NFI), also called Von Recklinghausen disease, is an autosomal dominant disease secondary to a genetic mutation on the long arm of chromosome 17. This disorder affects neural crest cells. Cutaneous clinical forms are the most frequent with multiple benign skin neurofibromas, associated with café au lait skin spots and iris hamartomas. Vascular abnormalities in NF1 are rare but have also been well described. The most frequent abnormalities are characterized by arterial aneurysm degeneration, stenosis, and malformations. Venous locations are rare, but some cases of venous aneurysms were described with ruptures as complications. We present a rare case of thrombosed venous femoral aneurysm associated with a pulmonary embolism in a patient affected by NF1.

Paroxysmal finger haematoma--a benign acrosyndrome occurring in middle-aged women.

BACKGROUND: Paroxysmal finger haematoma (PFH) is an under-recognised vascular acrosyndrome with no epidemiological description to date. The aim of this work was to evaluate the prevalence, risk factors and clinical correlates of PFH in a population-based sample of subjects and to describe their semiological characteristics. PATIENTS AND METHODS: This cross-sectional study of random samples of the general population in three geographic areas of France involved 802 subjects, 548 women and 254 men, aged 18 to 84 years. The diagnosis of PFH was made from a report by the subject of a history of recurrent haematoma in the fingers with a sudden, painful and unexpected occurrence. Diagnosis of associated conditions and evaluation of lifestyle variables were obtained through standardised medical interview and examination. RESULTS: A history of PFH was detected in 71 subjects, with a prevalence of 1.2% in men and 12.4% in women; there was no significant regional variation. Onset before 40 years of age was rare. Besides female sex and age, no socio-economical nor lifestyle risk factors were detected. PFH was associated with Raynaud phenomenon and a history of chilblains, but no link with any health threatening disease was found. In addition to the sudden onset of pain and hematoma, the main clinical features were a frequent digital swelling during the painful attack, and their predominant location on the volar side of the first and second phalanges of the third or second fingers of the dominant hand. CONCLUSIONS: PFH is a benign phenomenon, frequently found in middle-aged women, to be classified among the vascular acrosyndromes. Patients seeking medical evaluation for this disorder should be reassured.

Treprostinil Iontophoresis Improves Digital Blood Flow during Local Cooling in Systemic Sclerosis.

INTRODUCTION: Severe Raynaud's syndrome and DUs are the most prevalent manifestations of SSc peripheral microvascular disease. We tested whether treprostinil iontophoresis on the finger pad of patients with SSc would improve digital blood flow during hand cooling. METHODS: Eleven patients with limited cutaneous SSc underwent a double-blinded iontophoresis of treprostinil (2.56 × 10(-4) M during two hours) and placebo (NaCl 0.9%) on two finger pads. Then, the hand was inserted for 30 minutes in a fenestrated cooling box at 8 °C, and skin blood flow was recorded continuously using LSCI. RESULTS: During the local cooling, CVC was significantly higher at the treprostinil site than at the placebo site and remained higher 30 minutes after the test. CONCLUSIONS: In patients with SSc, digital treprostinil iontophoresis shifts skin blood flow upward during local cooling of the hand and during the initial rewarming phase. Digital treprostinil iontophoresis should now be tested in larger scale studies.

Effect of a retrievable inferior vena cava filter plus anticoagulation vs anticoagulation alone on risk of recurrent pulmonary embolism: a randomized clinical trial.

IMPORTANCE: Although retrievable inferior vena cava filters are frequently used in addition to anticoagulation in patients with acute venous thromboembolism, their benefit-risk ratio is unclear. OBJECTIVE: To evaluate the efficacy and safety of retrievable vena cava filters plus anticoagulation vs anticoagulation alone for preventing pulmonary embolism recurrence in patients presenting with acute pulmonary embolism and a high risk of recurrence. DESIGN, SETTING, AND PARTICIPANTS: Randomized, open-label, blinded end point trial (PREPIC2) with 6-month follow-up conducted from August 2006 to January 2013. Hospitalized patients with acute, symptomatic pulmonary embolism associated with lower-limb vein thrombosis and at least 1 criterion for severity were assigned to retrievable inferior vena cava filter implantation plus anticoagulation (filter group; n = 200) or anticoagulation alone with no filter implantation (control group; n = 199). Initial hospitalization with ambulatory follow-up occurred in 17 French centers. INTERVENTIONS: Full-dose anticoagulation for at least 6 months in all patients. Insertion of a retrievable inferior vena cava filter in patients randomized to the filter group. Filter retrieval was planned at 3 months from placement. MAIN OUTCOMES AND MEASURES: Primary efficacy outcome was symptomatic recurrent pulmonary embolism at 3 months. Secondary outcomes were recurrent pulmonary embolism at 6 months, symptomatic deep vein thrombosis, major bleeding, death at 3 and 6 months, and filter complications. RESULTS: In the filter group, the filter was successfully inserted in 193 patients and was retrieved as planned in 153 of the 164 patients in whom retrieval was attempted. By 3 months, recurrent pulmonary embolism had occurred in 6 patients (3.0%; all fatal) in the filter group and in 3 patients (1.5%; 2 fatal) in the control group (relative risk with filter, 2.00 [95% CI, 0.51-7.89]; P = .50). Results were similar at 6 months. No difference was observed between the 2 groups regarding the other outcomes. Filter thrombosis occurred in 3 patients. CONCLUSIONS AND RELEVANCE: Among hospitalized patients with severe acute pulmonary embolism, the use of a retrievable inferior vena cava filter plus anticoagulation compared with anticoagulation alone did not reduce the risk of symptomatic recurrent pulmonary embolism at 3 months. These findings do not support the use of this type of filter in patients who can be treated with anticoagulation. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00457158.

Recanalization and stenting of a post-thrombotic iliac vein in a patient with Behçet's disease.

Vascular lesions are frequent in Behçet's disease, and among them, deep venous thrombosis may occur in up to one-third of patients. Treatment is based on immunosuppressive drugs in addition to anticoagulants. We report the case of a young woman who presented with an acute iliofemoral venous thrombosis. Acute treatment with endovascular thrombectomy and catheter-directed fibrinolysis failed, probably because of the inflammatory status of the vessel wall. Recanalization with stenting of the obstructed common femoral and iliac veins 1 year later was successful under immunosuppressive therapy. This case suggests that endovascular treatment of venous thrombosis in Behçet's disease may be conducted successfully in nonactive venous lesions under immunosuppressive therapy.

Effects of short-term treatment with vitamin E in systemic sclerosis: a double blind, randomized, controlled clinical trial of efficacy based on urinary isoprostane measurement.

This double blind randomized controlled trial was designed to investigate whether short-term vitamin E treatment at doses of 500 and 1000 mg/day, compared to placebo, decreased urinary F(2)-isoprostanes and improved the microvascular perfusion after cold exposure in patients suffering from SSc. Thirty-three eligible patients were randomly assigned in a 1.3:1:1 ratio to receive placebo, vitamin E 500 mg, or vitamin E 1000 mg daily for 3 weeks. Clinical examination, analysis of plasma vitamin E, urinary F(2)-isoprostane levels and a whole body cooling test were performed at baseline and after a 3-week period of treatment. Urinary 15-F(2t)-IsoP levels and cutaneous blood flow variation in response to cold did not significantly differ before versus after treatment in any group. Furthermore, no difference was found between groups after 3 weeks of treatment. We show that 3-week vitamin E treatment at doses of 500 or 1000 mg/day neither decreases the basal rate of lipid peroxidation nor improves microvascular perfusion after cold exposure. These data does not support the need for phase III clinical trials to test efficacy of vitamin E in SSc.