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1.
Phlebology ; 39(5): 302-309, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38193832

ABSTRACT

BACKGROUND: Edema in some subjects worsens over time and wraps help to reduce the leg volume. MATERIAL AND METHODS: An adjustable compression wrap was tried on volunteers for 5 h and volumes measured in each limb before and after wrapping using a 3D surface scanner (HandySCAN 3D®) to estimate the volume of the leg. The contralateral leg was used as control. RESULTS: We observed a significant decrease in volume in the wrap legs and an increase in the control legs (p < .001), both in the lower part of leg (p = .001) and in the upper part (p = .001). CONCLUSIONS: Using the Readywrap® for 5 hours significantly reduces the leg volume. This study enables Readywrap to be studied in a population that is easy to observe in the context of a research program. The Handyscan3D® was shown accurate and reproducible to assess leg volume in future studies.


Subject(s)
Compression Bandages , Edema , Leg , Humans , Male , Adult , Female , Middle Aged , Occupational Diseases
2.
Front Med (Lausanne) ; 10: 1144102, 2023.
Article in English | MEDLINE | ID: mdl-36873893

ABSTRACT

Background: The cutaneous microangiopathy plays a key role in the development of the skin clinical lesions of venous insufficiency. Capillaroscopy allows a non-invasive observation of the superficial skin capillaries of the lower leg, which have previously been shown to be altered in patients with advanced venous disease. As it is now available in a friendly, easy to handle way through modern video devices, we report our findings in a short series of patients with C3-C5 chronic venous disorders using this technique. Methods: A total of 21 patients with venous insufficiency (C3-C5 on at least one leg) underwent a capillaroscopic examination of both legs and pictures recorded from the sites of the most severe venous skin lesions. This was performed with a CapXview handheld video-capillaroscope (×100 magnification), allowing easy manual measurement of maximum capillary bulk diameter and capillary density. Results: Dramatic changes in capillary density, size, and shape were easily observed at the site of the venous skin lesions. A significant negative linear relationship was found between capillary density and the "C" classes (r = -0.45; P < 0.001). A significant negative correlation was also found between capillary density and bulk diameter (r = -0.52; P < 0.001). The area under the ROC curve for the mathematical prediction of venous skin changes by capillary density was 0.842, which shows the strength of the link between the microvascular and the clinical status. Conclusion: Video-capillaroscopy allows a direct observation of the cutaneous venous microangiopathy and provides the possibility to measure capillary density which allows its quantification. This simple to use technique shows the potential for a more precise follow-up and treatment evaluation of the cutaneous consequences of venous disease, which remains to be further investigated.

3.
Microvasc Res ; 142: 104365, 2022 07.
Article in English | MEDLINE | ID: mdl-35367233

ABSTRACT

Systemic sclerosis may be complicated by digital ulcers. Nailfold capillaroscopy on one finger might reflect an increased risk of digital ulcer (DU). In the present study we studied the correlations between a history of ulcer and capillary findings on the finger. METHOD: This study is part of Sclerocap, a multicenter study aiming at validating prospectively the prognostic value of Maricq's and Cutolo's capillaroscopic classifications during a three-year longitudinal follow-up. A history of past or present digital ulcer was recorded at inclusion and nailfold capillaroscopy was performed. Elementary findings as well as Cutolo and Maricq's classifications were assessed. RESULTS: 387 patients were included in Sclerocap (327 females, 60 males) and 3096 fingers were examined by capillaroscopy at inclusion: 316 fingers (10%) belonging to 113 patients had a history of DU. Late Cutolo's stage was statistically correlated with a history of DU, both by univariate: OR 2.08 [1.09-3.96] and multivariate analysis: OR 1.97 [1.06-3.63]. Among the elemental abnormalities, only edema and decreased capillary density were correlated with a history of DU by multivariate analysis: respectively OR 1.92 [1.17-3.16] and 0.65 [0.49-0.85]. CONCLUSION: This cross-sectional study in a large cohort of patients with systemic sclerosis shows a correlation between a history of digital ulcer and edema, a decrease in capillary density and the late stage in Cutolo's classification. The extent of capillary abnormalities on one finger is associated with a history of local digital ulcer. Capillaroscopy might be used to predict the risk of DU but these results need first to be confirmed by prospective studies.


Subject(s)
Scleroderma, Systemic , Skin Ulcer , Capillaries/diagnostic imaging , Cross-Sectional Studies , Female , Fingers/blood supply , Humans , Male , Microscopic Angioscopy/methods , Nails , Prospective Studies , Scleroderma, Systemic/complications , Scleroderma, Systemic/diagnosis , Skin Ulcer/diagnosis , Skin Ulcer/etiology , Ulcer/complications
4.
Article in English | MEDLINE | ID: mdl-35162199

ABSTRACT

The prognosis of chronic venous insufficiency (CVI) is greatly depending upon the ability of the patients to optimize their health-related behaviors (mainly compliance to compression stockings, physical activity and diet). As this is usually challenging for the patients, we developed a therapeutic education program (TEP) aiming at helping them to achieve these optimizations. We report here the preliminary results obtained with this program. This structured TEP was developed by a working group of 15 health professionals to be used during the regular French spa 3-week treatment course for CVI patients. The program included three interactive workshops aiming at improving the patients' knowledge, skills and motivation, two educational consultations allowing to set and follow-up their personal action plans and a built-in evaluation. It was implemented in spa resorts specialized in CVI. Among the first 150 patients (116 women and 34 men, mean age 69 years old (SD 8 years), 49% had post-thrombotic disease. Compliance to the education workshops was 98%. After a 3-month follow-up, 83% of the patients fully achieved at least one behavioral objective. Quality of life, as assessed by the CIVIQ 2 auto-questionnaire, improved at 3 months (p = 0.0024) and 9 months (p = 0.018). These results demonstrate the feasibility of a TEP for CVI patients and its ability to improve their health-related behaviors, opening the way for the development of similar programs for other chronic diseases in the setting of spa resorts.


Subject(s)
Quality of Life , Venous Insufficiency , Aged , Chronic Disease , Female , Humans , Male , Motivation , Patient Education as Topic , Venous Insufficiency/therapy
5.
Arthritis Care Res (Hoboken) ; 74(5): 828-832, 2022 05.
Article in English | MEDLINE | ID: mdl-33278327

ABSTRACT

OBJECTIVE: To evaluate the prevalence and clinical correlates of peripheral arterial disease of the upper limbs in patients with systemic sclerosis (SSc), as detected with finger brachial pressure index (FBPI) measurements. METHODS: This work is based on the baseline data of the SCLEROCAP multicenter cohort of SSc patients. Finger systolic blood pressure was measured with laser Doppler flowmetry, and the FBPI was obtained as its ratio over the ipsilateral brachial systolic blood pressure. An FBPI of <0.70 was used as the diagnostic criterion for occlusive arterial disease of the upper limbs. Thus, the prevalence of defined arterial disease as well as its clinical, biologic, and capillaroscopic correlates were evaluated. RESULTS: Among 326 enrolled patients, 177 (54.3%) met the criterion for arterial disease (FBPI <0.70). No association was found with the type of SSc nor with the type of associated antinuclear antibodies, but a significant association was found with the duration of the disease (P < 0.001), the capillaroscopic pattern (P < 0.001), and most strikingly with the presence of digital ulcers (42.9% versus 13.4%; P < 0.001). A quantitative relationship was found between the FBPI and the prevalence of digital ulcers and was shown to be independent from the capillaroscopic pattern. CONCLUSION: This cross-sectional study shows a high prevalence of arterial disease of the upper limbs in patients with SSc. FBPI appears to be a strong and independent predictor of digital ulcers. This study suggests that both macro- and microangiopathy are contributing to the ischemic damage of the fingertips.


Subject(s)
Scleroderma, Systemic , Skin Ulcer , Blood Pressure , Cross-Sectional Studies , Humans , Microscopic Angioscopy , Scleroderma, Systemic/complications , Scleroderma, Systemic/diagnosis , Scleroderma, Systemic/epidemiology , Skin Ulcer/diagnosis , Ulcer/complications
7.
Microvasc Res ; 131: 104029, 2020 09.
Article in English | MEDLINE | ID: mdl-32531354

ABSTRACT

OBJECTIVE: Finger systolic blood pressure measurement (FSBP) has been shown helpful in the detection of distal arterial insufficiency in upper limbs. This work assesses the possibility to measure FSBP on the 2nd phalanx instead of the first one in order to improve its sensitivity and to verify this would not alter the repeatability of the measurement. METHODS: In this multicenter study, FSBP was measured twice in all fingers but the thumbs in consecutive systemic sclerosis patients on the first phalanx and the second phalanx in alternate order using laser-Doppler flowmetry. RESULTS: Thirty-seven patients were enrolled. The repeatability of FSBP was excellent and similar on the first and 2nd phalanxes with coefficients of variation respectively of 7.1% and 7.6%. While the correlation between the FSBP at the two sites was fair (Pearson coefficient 0.69; p < 0.001). The agreement was poor, with a mean difference of 14 mm Hg between the two sites. Significantly higher differences were found in fingers with digital ulcers. The ROC curves showed a better prediction of the 2nd phalanx measurements. CONCLUSION: FSBP has an excellent repeatability whatever the site of phalanx. However, measurements performed on the 2nd phalanx have a better sensitivity for the prediction of digital ulcers.


Subject(s)
Blood Pressure Determination/methods , Blood Pressure , Fingers/blood supply , Laser-Doppler Flowmetry , Scleroderma, Systemic/diagnosis , Skin Ulcer/diagnosis , Blood Flow Velocity , Humans , Longitudinal Studies , Paris , Predictive Value of Tests , Prospective Studies , Reproducibility of Results , Scleroderma, Systemic/physiopathology , Skin Ulcer/physiopathology , Time Factors
8.
Ann Phys Rehabil Med ; 63(6): 466-473, 2020 Nov.
Article in English | MEDLINE | ID: mdl-32272287

ABSTRACT

OBJECTIVE: Supervised exercise training is part of first-line therapies for intermittent claudication. Short periods of intensive treadmill training have been found efficient; however, the optimal modalities remain to be determined, especially interval training with active recovery (ITAR). In this prospective assessor-blinded single-centre pilot study, we assessed the feasibility of a randomised controlled trial comparing parallel 4-week intensive rehabilitation programs comprising treadmill training performed as ITAR or conventional training with constant slope and speed interspersed with rest periods (CT). METHODS: A total of 38 in- or out-patients were randomised to the ITAR or CT program for 5 days/week for 4weeks. The primary outcome was change in maximum walking distance measured on a graded treadmill before and after the program. RESULTS: Adherence was high. All training sessions were completed in the ITAR program and only a few were not completed in the CT program (median 100% [Q1-Q3 96-100]). Tolerance was excellent (no adverse events). VO2peak was low in both groups, corresponding to moderate to severe exercise intolerance. The 2 groups did not differ in the primary outcome (median ITAR vs CT 480 [135-715] vs 315m [0-710]; p=0.62) or other walking distances (constant speed and gradient treadmill test). For all 38 participants, both programs greatly increased maximum walking distance in the graded treadmill test: median 415 [240-650] to 995m [410-1490], with a large effect size (p<10-4). CONCLUSION: A 4-week intensive rehabilitation program with ITAR or CT for intermittent claudication showed high adherence, was well tolerated, and improved walking distance as much as that reported for longer conventional programs. These findings prompt the design of a larger multicenter randomised controlled trial. TRIAL REGISTRATION: NCT01734603.


Subject(s)
Cardiac Rehabilitation/methods , Exercise Therapy/methods , Intermittent Claudication/rehabilitation , Peripheral Arterial Disease/rehabilitation , Walking , Cardiorespiratory Fitness , Exercise Test , Exercise Tolerance , Feasibility Studies , Female , Humans , Intermittent Claudication/etiology , Intermittent Claudication/physiopathology , Male , Middle Aged , Patient Compliance , Peripheral Arterial Disease/complications , Pilot Projects , Prospective Studies , Single-Blind Method , Time Factors , Treatment Outcome
9.
Phlebology ; 35(7): 447-460, 2020 Aug.
Article in English | MEDLINE | ID: mdl-32122269

ABSTRACT

OBJECTIVES: Medical compression therapy is used for non-invasive treatment of venous and lymphatic diseases. Medical compression therapy-associated adverse events and contraindications have been reported, although some contraindications are theoretically based. This consensus statement provides recommendations on medical compression therapy risks and contraindications. METHODS: A systematic literature search of medical compression therapy publications reporting adverse events up until November 2017 was performed. A consensus panel comprising 15 international experts critically reviewed the publications and formulated the recommendations. RESULTS: Sixty-two publications reporting medical compression therapy adverse events were identified. The consensus panel issued 21 recommendations on medical compression therapy contraindications and adverse event risk mitigation, in addition to reviewing medical compression therapy use in borderline indications. The most frequently reported non-severe medical compression therapy-associated adverse events included skin irritation, discomfort and pain. Very rare but severe adverse events, including soft tissue and nerve injury, were also identified. CONCLUSION: This consensus statement summarises published medical compression therapy-associated adverse events and contraindications, and provides guidance on medical compression therapy. Severe medical compression therapy-associated adverse events are very rarely encountered if compression is used correctly and contraindications are considered.


Subject(s)
Lymphatic Diseases , Compression Bandages , Consensus , Contraindications , Humans
10.
J Vasc Surg Venous Lymphat Disord ; 8(3): 342-352, 2020 05.
Article in English | MEDLINE | ID: mdl-32113854

ABSTRACT

The CEAP (Clinical-Etiology-Anatomy-Pathophysiology) classification is an internationally accepted standard for describing patients with chronic venous disorders and it has been used for reporting clinical research findings in scientific journals. Developed in 1993, updated in 1996, and revised in 2004, CEAP is a classification system based on clinical manifestations of chronic venous disorders, on current understanding of the etiology, the involved anatomy, and the underlying venous pathology. As the evidence related to these aspects of venous disorders, and specifically of chronic venous diseases (CVD, C2-C6) continue to develop, the CEAP classification needs periodic analysis and revisions. In May of 2017, the American Venous Forum created a CEAP Task Force and charged it to critically analyze the current classification system and recommend revisions, where needed. Guided by four basic principles (preservation of the reproducibility of CEAP, compatibility with prior versions, evidence-based, and practical for clinical use), the Task Force has adopted the revised Delphi process and made several changes. These changes include adding Corona phlebectatica as the C4c clinical subclass, introducing the modifier "r" for recurrent varicose veins and recurrent venous ulcers, and replacing numeric descriptions of the venous segments by their common abbreviations. This report describes all these revisions and the rationale for making these changes.


Subject(s)
Postthrombotic Syndrome/classification , Terminology as Topic , Varicose Veins/classification , Veins , Venous Insufficiency/classification , Chronic Disease , Consensus , Delphi Technique , Evidence-Based Medicine , Humans , Postthrombotic Syndrome/diagnosis , Postthrombotic Syndrome/physiopathology , Postthrombotic Syndrome/therapy , Predictive Value of Tests , Prognosis , Severity of Illness Index , Varicose Veins/diagnosis , Varicose Veins/physiopathology , Varicose Veins/therapy , Veins/physiopathology , Venous Insufficiency/diagnosis , Venous Insufficiency/physiopathology , Venous Insufficiency/therapy
11.
Joint Bone Spine ; 87(3): 229-233, 2020 May.
Article in English | MEDLINE | ID: mdl-32050096

ABSTRACT

INTRODUCTION: In systemic sclerosis, few studies have shown that hand and wrist ultrasound is more sensitive than clinical examination in the detection of synovitis and tenosynovitis. Even fewer studies have investigated ankle and foot involvement with ultrasound. Our objectives were to investigate ultrasound prevalence of wrist, hand, ankle and foot synovitis and tenosynovitis in patients with systemic sclerosis classified with ACR/EULAR 2013 criteria, and to study their relationship with disease features and hand disability. METHODS: Consecutive patients with systemic sclerosis, classified with ACR/EULAR 2013 criteria, were included in a monocentric cross-sectional study. They underwent standardized musculoskeletal clinical examination and hand, wrist, ankle and foot ultrasound. Clinical, biological and imaging data were also collected. RESULTS: Fifty-five patients were included. Ultrasound was more sensitive than clinical examination to detect at least one synovitis (respectively 52% versus 25%, P=0.025) and at least one tenosynovitis (respectively 16% versus 4%, P=0.009); 18% of patients had ankle tenosynovitis and 29% had ankle and/or foot synovitis, mostly located at metatarsophalangeal joints (25.5%). Having at least one ultrasound hand synovitis was associated with higher Cochin hand functional disability scale (mean 25±3 versus 12±2, P=0.003) and diffuse cutaneous subset (P=0.038). CONCLUSION: Our study shows that ultrasound is more sensitive than clinical examination to detect synovitis and tenosynovitis in systemic sclerosis. The foot involvement is less frequent than hand involvement, mainly localized at metatarsophalangeal joint. Finally, having at least one synovitis of the hand is associated with diffuse cutaneous subset and higher hand disability.


Subject(s)
Scleroderma, Systemic , Synovitis , Tenosynovitis , Ankle , Cross-Sectional Studies , Hand/diagnostic imaging , Humans , Prevalence , Scleroderma, Systemic/complications , Scleroderma, Systemic/diagnostic imaging , Scleroderma, Systemic/epidemiology , Synovitis/diagnostic imaging , Synovitis/epidemiology , Tenosynovitis/diagnostic imaging , Tenosynovitis/epidemiology , Wrist , Wrist Joint/diagnostic imaging
12.
Vasa ; 49(3): 230-234, 2020 Apr.
Article in English | MEDLINE | ID: mdl-32026753

ABSTRACT

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.


Subject(s)
Blood Gas Monitoring, Transcutaneous , Ischemia , Blood Pressure , Cross-Sectional Studies , Fluorescein Angiography , Humans , Toes
14.
Clin Exp Rheumatol ; 37 Suppl 119(4): 63-68, 2019.
Article in English | MEDLINE | ID: mdl-31172926

ABSTRACT

OBJECTIVES: We assessed the correlation between severity of systemic sclerosis (SSc) and current staging systems based on nailfold capillaroscopy. METHODS: SCLEROCAP is a multicenter prospective study including consecutive scleroderma patients who have a yearly routine follow-up with capillaroscopy and digital blood pressure measurement. Capillaroscopy images were read by two observers blinded from each other, then by a third one in the case of discordance. A follow-up of 3 years is planned. The present study assessed the correlation between severity of systemic sclerosis (SSc) and current staging systems based on nail fold capillaroscopy at enrollment in the SCLEROCAP study. Univariate and multivariate logistic regression analysis was performed for both the Maricq and Cutolo classifications. RESULTS: SCLEROCAP included 387 patients in one year. Maricq's active and Cutolo's late classifications were very similar. In multivariate analysis, the number of digital ulcers (OR for 2 ulcers or more, respectively 2.023 [1.074-3.81] and 2.596 [1.434-4.699]) and Rodnan's skin score >15 (OR respectively 32.007 [6.457-158.658] and 18.390 [5.380-62.865]) correlated with Maricq's active and Cutolo's late stages. Haemoglobin rate correlated with Cutolo's late stage (hemoglobin<100 vs. >120 g/dl: OR 0.223 [0.051-0.980]), and total lung capacity with Maricq's active one: increase in 10%: OR0.833 [0.717-0.969]. CONCLUSIONS: The correlations found between capillaroscopy and severity of SSc are promising before the ongoing prospective study definitively assesses whether capillaroscopy staging predicts complications of SSc. Only two capillaroscopic patterns seem useful: one involving many giant capillaries and haemorrhages and the other with severe capillary loss.


Subject(s)
Microscopic Angioscopy/methods , Scleroderma, Systemic , Skin Ulcer , Capillaries , Female , Humans , Male , Nails , Prospective Studies , Scleroderma, Systemic/classification , Scleroderma, Systemic/pathology , Severity of Illness Index , Skin Ulcer/classification , Skin Ulcer/pathology
15.
Cardiovasc Intervent Radiol ; 42(8): 1117-1127, 2019 Aug.
Article in English | MEDLINE | ID: mdl-31062068

ABSTRACT

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.


Subject(s)
Arterial Occlusive Diseases/surgery , Endovascular Procedures/methods , Femoral Vein/surgery , Iliac Vein/surgery , Postthrombotic Syndrome/surgery , Adolescent , Adult , Aged , Aged, 80 and over , Arterial Occlusive Diseases/complications , Arterial Occlusive Diseases/diagnostic imaging , Female , Femoral Vein/diagnostic imaging , Humans , Iliac Vein/diagnostic imaging , Male , Middle Aged , Postthrombotic Syndrome/complications , Prognosis , Retrospective Studies , Treatment Outcome , Ultrasonography, Doppler, Color , Young Adult
16.
Int Angiol ; 38(2): 83-89, 2019 Apr.
Article in English | MEDLINE | ID: mdl-31056892

ABSTRACT

BACKGROUND: To show the efficacy of micronized purified flavonoid fraction (MPFF) 1000 mg in the mild cases of chronic venous disorders (CVD), i.e. in C0s-C1 patients according to the CEAP classification. METHODS: In an international, randomized, double-blind, parallel-group study, symptomatic C0s to C4 patients according to the Clinical Etiological Anatomic Pathophysiologic (CEAP) were treated for 8 weeks by either MPFF 1000 mg once daily or MPFF 500 mg twice daily. The present post-hoc analysis is focused on the efficacy of MPFF at the daily doses of 1000 mg in the population of mild cases of the CVD (C0s-C1 patients) on lower limb discomfort, leg pain and leg heaviness using a 10-cm Visual Analog Scale (VAS), and on quality of life (QoL) using CIVIQ-20. RESULTS: In the 256 patients of the C0s-C1 subset of the study patients, lower limb discomfort improvement measured on VAS was clinically and statistically significant: -2.87±2.38 cm in the MPFF 1000 mg group and -3.30±2.36 cm in the MPFF 500 mg group (P<0.001 in both groups). Leg pain and leg heaviness VAS improved similarly: -2.77±2.58 cm in the MPFF 1000 mg group and -3.45±2.38 cm in the MPFF 500 mg group (P<0.001 in both groups), and -2.91±2.47 cm in the MPFF 1000 mg group and -3.47±2.33 cm in the MPFF 500 mg group (P<0.001 in both groups). The quality of life assessed by the CIVIQ-20 questionnaire improved significantly in both treatment groups from baseline to W8 with a mean changes of global index score of -16.53±14.18 in the MPFF 1000 mg group and -18.78±18.14 in the MPFF 500 mg group (P<0.001). CONCLUSIONS: MPFF at the daily dose of 1000 mg was shown to have a similar efficacy in mild CVD cases (C0s-C1 patients) as in the whole spectrum of patients from the main study, with a very good safety profile. These result further illustrates the interest of MPFF in the management of the mild cases of the disease at a daily dose of 1000 mg.


Subject(s)
Flavonoids/administration & dosage , Lower Extremity/blood supply , Vascular Diseases/drug therapy , Adult , Aged , Chronic Disease , Double-Blind Method , Female , Flavonoids/adverse effects , Humans , Internationality , Lower Extremity/physiopathology , Male , Middle Aged , Pain Management , Pain Measurement , Quality of Life , Surveys and Questionnaires , Vascular Diseases/physiopathology , Visual Analog Scale , Young Adult
17.
Ann Intern Med ; 169(10): 694-703, 2018 11 20.
Article in English | MEDLINE | ID: mdl-30383134

ABSTRACT

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.


Subject(s)
Phosphodiesterase 5 Inhibitors/administration & dosage , Phosphodiesterase 5 Inhibitors/adverse effects , Raynaud Disease/drug therapy , Sildenafil Citrate/administration & dosage , Sildenafil Citrate/adverse effects , Vasodilator Agents/administration & dosage , Vasodilator Agents/adverse effects , Adult , Cross-Over Studies , Data Interpretation, Statistical , Double-Blind Method , Drug Administration Schedule , Female , Humans , Male , Middle Aged , Prospective Studies , Treatment Outcome
18.
Int Angiol ; 37(6): 437-443, 2018 Dec.
Article in English | MEDLINE | ID: mdl-30256052

ABSTRACT

The aim of this review was to discuss the different techniques of leg edema measurement that have been used in clinical trials to help determine the most appropriate method of assessment and quantification for use in future research. Venoactive drugs such as micronized purified flavonoid fraction (MPFF) are established agents for the treatment of venous leg edema, but results from randomized-controlled trials vary depending on the method of edema assessment. The medical literature was searched for published articles using the terms "venous lower limb edema" and "method of edema assessment." Clinical trials performed with MPFF used leg circumference and optometry for leg edema assessment. Indirect methods of lower limb volume assessment can be made by measurement of leg circumference with a tape or Leg-O-Meter. These are reliable and standardized instruments and simple and rapid to perform. Leg circumference measurements can also be used to indirectly estimate leg volume using the Frustum method. Direct methods such as water displacement volumetry are generally regarded as the gold standard for measurement of lower limb volume with low inter- and intra-individual variability. Nevertheless, to minimize variation in results measurement conditions must be standardized. The reproducibility of optometry can be considered good when positioning of the limb is appropriate. Other techniques also exist such as ultrasound imaging, bioelectrical impedance, tomodensitometry, Dual X-ray absorptiometry, computed tomography and magnetic resonance imaging. The different methods may be used to measure different compartments of the leg with or without the foot volume. For all techniques, strict standardization of measurement conditions is mandatory. Patient heterogeneity and method of edema assessment impact clinical trial results. In particular, there are a number of error sources with several methods of assessment that can lead to variability in trial results. Consequently, pilot studies are required to validate new methods of edema assessment using innovative technologies.


Subject(s)
Anthropometry/methods , Edema/diagnosis , Lower Extremity , Peripheral Vascular Diseases/diagnosis , Veins , Edema/diagnostic imaging , Edema/pathology , Edema/physiopathology , Electric Impedance , Humans , Lower Extremity/blood supply , Lower Extremity/diagnostic imaging , Lower Extremity/pathology , Patient Positioning , Peripheral Vascular Diseases/diagnostic imaging , Peripheral Vascular Diseases/pathology , Peripheral Vascular Diseases/physiopathology , Predictive Value of Tests , Prognosis , Reproducibility of Results , Veins/pathology , Veins/physiopathology
20.
Phlebology ; 33(3): 163-184, 2018 Apr.
Article in English | MEDLINE | ID: mdl-28549402

ABSTRACT

Objective Medical compression stockings are a standard, non-invasive treatment option for all venous and lymphatic diseases. The aim of this consensus document is to provide up-to-date recommendations and evidence grading on the indications for treatment, based on evidence accumulated during the past decade, under the auspices of the International Compression Club. Methods A systematic literature review was conducted and, using PRISMA guidelines, 51 relevant publications were selected for an evidence-based analysis of an initial 2407 unrefined results. Key search terms included: 'acute', CEAP', 'chronic', 'compression stockings', 'compression therapy', 'lymph', 'lymphatic disease', 'vein' and 'venous disease'. Evidence extracted from the publications was graded initially by the panel members individually and then refined at the consensus meeting. Results Based on the current evidence, 25 recommendations for chronic and acute venous disorders were made. Of these, 24 recommendations were graded as: Grade 1A (n = 4), 1B (n = 13), 1C (n = 2), 2B (n = 4) and 2C (n = 1). The panel members found moderately robust evidence for medical compression stockings in patients with venous symptoms and prevention and treatment of venous oedema. Robust evidence was found for prevention and treatment of venous leg ulcers. Recommendations for stocking-use after great saphenous vein interventions were limited to the first post-interventional week. No randomised clinical trials are available that document a prophylactic effect of medical compression stockings on the progression of chronic venous disease (CVD). In acute deep vein thrombosis, immediate compression is recommended to reduce pain and swelling. Despite conflicting results from a recent study to prevent post-thrombotic syndrome, medical compression stockings are still recommended. In thromboprophylaxis, the role of stockings in addition to anticoagulation is limited. For the maintenance phase of lymphoedema management, compression stockings are the most important intervention. Conclusion The beneficial value of applying compression stockings in the treatment of venous and lymphatic disease is supported by this document, with 19/25 recommendations rated as Grade 1 evidence. For recommendations rated with Grade 2 level of evidence, further studies are needed.


Subject(s)
Lymphatic Diseases/therapy , Postthrombotic Syndrome/prevention & control , Stockings, Compression , Clinical Trials as Topic , Consensus , Humans , Practice Guidelines as Topic
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