Segmental differences in daytime changes of leg volume.

BACKGROUND: The aim of our study was to comparatively assess volume changes related to daily occupation of the whole leg (WLv), of the lower leg (LLv) and of the upper leg (ULv) in subject with no venous and lymphatic disorders. METHOD: WLv, LLv, and Ulv were evaluated by water displacement volumetry (WDV) in the morning and in the evening in 20 healthy subjects. RESULTS: In the legs with occupational edema (OE), WLv increased by 7.07%, LLv by 5.25%, and ULv by 9.80%. In legs without clear OE, WLv increased by 2.41%, LLv by 1.35, and ULv by 3.38%. CONCLUSIONS: Surprisingly, the increase of ULv was greater than that of LLv. An evening increase in the leg volume also occurred in legs with no clear OE. In our series, a clinically evident OE was related to an increase of the WLv, LLv, and ULv greater than 5.83%, 8.68%, and 1.88%, respectively.

Pressure and stiffness of a new air-inflated compression wrap.

OBJECTIVE: To report pressure and stiffness, in healthy volunteers, of a new compression device with an air bladder inflated by a pump to regulate pressure. METHODS: The device was applied to 60 legs of 30 volunteers and set to exert different pressures of 20-50 mmHg. The exerted pressure was measured in supine and standing positions and during simple physical exercises; static stiffness index, dynamic stiffness index, and walking pressure amplitudes were calculated. RESULTS: The exerted pressure showed a good correlation with the expected pressure at each pressure range. The stiffness indices were >10 mmHg in the range of inelastic materials. The device was considered very easy to apply and use by the testing researchers. CONCLUSIONS: The device stiffness is in the same range as the inelastic bandages. Consequently, similar hemodynamic effectiveness could be expected but must be proved. Unlike inelastic bandages, this device was easy to apply and use.

Effects of lower limb muscle strengthening on interface pressure in older adults undergoing inelastic compression: Randomized controlled clinical trial.

OBJECTIVE: To analyze the effects of lower limb muscle strengthening on interface pressure (IP), static stiffness index (SSI), dynamic stiffness index (DSI), and walking pressure amplitude (WPA) in older adults undergoing inelastic compression therapy. METHOD: Forty-three healthy older adults of both sexes (Age: 66.2 ± 4.4 years) met the eligibility criteria and completed all stages of the study (Resistance Training - RT: N = 20; Control - CONT: N = 23). Body composition, strength and functional mobility of lower limbs, IP, SSI, DSI, and WPA were evaluated before and after intervention. RESULTS: The two-way ANOVA with repeated measures demonstrated a significant time-group interaction effect on muscular strength for 1-RM [F (1, 41) = 21.091; p ≤ 0.001], IP in the orthostatic position [F (1, 41) = 5.124; p ≤ 0.05], minimum WPA [F (1, 41) = 10.999; p ≤ 0.05], maximum WPA [F (1, 41) = 8.315; p ≤ 0.05], DSI minimum (F (1, 41) = 4.608; p ≤ 0.05), DSI maximum (F (1, 41) = 8.926; p ≤ 0.05), and on the delta DSI (F (1, 41) = 7.891; p ≤ 0.05). CONCLUSIONS: In RT group, the increase in lower limb muscle strength was accompanied by an increase in IP in foot dorsiflexion and plantar flexion maneuvers, both in the standing position (DSI) and during gait (WPA).

Black holes in compression therapy: A quest for data.

OBJECTIVE: Although compression therapy (CT) is considered a crucial conservative treatment in chronic venous disease, strong evidence is missing for many clinical indications. This literature review aims to point out what strong evidence we have for CT and all the clinical scenarios where strong evidence still needs to be included. METHODS: The research was conducted on MEDLINE with PubMed, Scopus and Web of Science. The time range was set between January 1980 and October 2022. Only articles in English were included. RESULTS: The main problem with CT is the low scientific quality of many studies on compression. Consequently, we have robust data on the effectiveness of CT only for advanced venous insufficiency (C3-C6), deep vein thrombosis and lymphedema. We have data on the efficacy of compression for venous symptoms control and in sports recovery, but the low quality of studies cannot result in a strong recommendation. For compression in postvenous procedures, superficial venous thrombosis, thromboprophylaxis, post-thrombotic syndrome prevention and treatment, and sports performance, we have either no data or very debated data not allowing any recommendation. CONCLUSIONS: We need high-level scientific studies to assess if CT can be effective or definitely ineffective in the clinical indications where we still have a paucity of or contrasting data.

No More Venous Ulcers-What More Can We Do?

Venous leg ulcers (VLUs) are the most severe complication caused by the progression of chronic venous insufficiency. They account for approximately 70-90% of all chronic leg ulcers (CLUs). A total of 1% of the Western population will suffer at some time in their lives from a VLU. Furthermore, most CLUs are VLUs, defined as chronic leg wounds that show no tendency to heal after three months of appropriate treatment or are still not fully healed at 12 months. The essential feature of VLUs is their recurrence. VLUs also significantly impact quality of life and could cause social isolation and depression. They also have a significant avoidable economic burden. It is estimated that the treatment of venous ulceration accounts for around 3% of the total expenditure on healthcare. A VLU-free world is a highly desirable aim but could be challenging to achieve with the current knowledge of the pathophysiology and diagnostic and therapeutical protocols. To decrease the incidence of VLUs, the long-term goal must be to identify high-risk patients at an early stage of chronic venous disease and initiate appropriate preventive measures. This review discusses the epidemiology, socioeconomic burden, pathophysiology, diagnosis, modes of conservative and invasive treatment, and prevention of VLUs.

Sclerotherapy of lower limb veins: Indications, contraindications and treatment strategies to prevent complications - A consensus document of the International Union of Phlebology-2023.

BACKGROUND: Sclerotherapy is a non-invasive procedure commonly used to treat superficial venous disease, vascular malformations and other ectatic vascular lesions. While extremely rare, sclerotherapy may be complicated by serious adverse events. OBJECTIVES: To categorise contraindications to sclerotherapy based on the available scientific evidence. METHODS: An international, multi-disciplinary panel of phlebologists reviewed the available scientific evidence and developed consensus where evidence was lacking or limited. RESULTS: Absolute Contraindications to sclerotherapy where the risk of harm would outweigh any benefits include known hypersensitivity to sclerosing agents; acute venous thromboembolism (VTE); severe neurological or cardiac adverse events complicating a previous sclerotherapy treatment; severe acute systemic illness or infection; and critical limb ischaemia. Relative Contraindications to sclerotherapy where the potential benefits of the proposed treatment would outweigh the risk of harm or the risks may be mitigated by other measures include pregnancy, postpartum and breastfeeding; hypercoagulable states with risk of VTE; risk of neurological adverse events; risk of cardiac adverse events and poorly controlled chronic systemic illness. Conditions and circumstances where Warnings and Precautions should be considered before proceeding with sclerotherapy include risk of cutaneous necrosis or cosmetic complications such as pigmentation and telangiectatic matting; intake of medications such as the oral contraceptive and other exogenous oestrogens, disulfiram and minocycline; and psychosocial factors and psychiatric comorbidities that may increase the risk of adverse events or compromise optimal treatment outcomes. CONCLUSIONS: Sclerotherapy can achieve safe clinical outcomes provided that (1) patient-related risk factors and in particular all material risks are (1a) adequately identified and the risk benefit ratio is clearly and openly discussed with treatment candidates within a reasonable timeframe prior to the actual procedure; (1b) when an individual is not a suitable candidate for the proposed intervention, conservative treatment options including the option of 'no intervention as a treatment option' are discussed; (1c) complex cases are referred for treatment in controlled and standardised settings and by practitioners with more expertise in the field; (1d) only suitable individuals with no absolute contraindications or those with relative contraindications where the benefits outweigh the risks are offered intervention; (1e) if proceeding with intervention, appropriate prophylactic measures and other risk-mitigating strategies are adopted and appropriate follow-up is organised; and (2) procedure-related risk factors are minimised by ensuring the treating physicians (2a) have adequate training in general phlebology with additional training in duplex ultrasound, procedural phlebology and in particular sclerotherapy; (2b) maintain their knowledge and competency over time and (2c) review and optimise their treatment strategies and techniques on a regular basis to keep up with the ongoing progress in medical technology and contemporary scientific evidence.

Rationale and current evidence of aquatic exercise therapy in venous disease: A narrative review.

Chronic venous disorders (CVD) of the lower limbs can be treated with different strategies. Typically, conservative management is based on compression therapy, anticoagulants and venoactive drugs. Endovenous treatments remain the gold standard to treat saphenous insufficiency, with sclerotherapy and surgery maintaining a role in selected cases. In addition, several 'unconventional' approaches have been proposed to prevent CVD progression and complications, minimize symptoms and improve the quality of life and postoperative outcomes. Among these, balneotherapy and aquatic exercises are proving as valid and effective supporting treatments, as mentioned in a growing number of scientific publications. Moreover, aquatic protocols have been studied for both venous and lymphatic insufficiency. For these reasons, they were mentioned in the last CVD guidelines provided by the European Society for Vascular Surgery. The aim of this narrative review is to overview and summarize current literature evidences on the role and effectiveness of aquatic rehabilitative protocols in CVD, reviewing old and current literature. Furthermore, the physical basis of the effects of water immersion on lower limb venous and tissues modifications are also described.

Subcutaneous calcifications in legs with chronic venous diseases.

BACKGROUND: Calcifications in the subcutaneous layer (SCL) have been described by radiographic studies of legs with advanced chronic venous disease (CVD). However, SCL calcifications have rarely been included among the CVD-related changes. The aim of the present study was to evaluate the prevalence and morphology of SCL calcifications in legs with CVD of all grades of severity determined by ultrasound. METHODS: A total of 500 legs in 250 patients (148 women and 102 men; mean age, 51 years; range, 18-87 years) referred to our vascular clinic for symptoms and signs of CVD were included. After duplex ultrasound evaluation of the deep, superficial, and perforating veins, the skin and SCL were investigated using duplex ultrasound. Those patients with other possible causes of SCL calcification were excluded. RESULTS: Using the C component of the CEAP (clinical, etiologic, anatomic, pathophysiologic) classification, 43 legs were classified as C1, 189 as C2, 34 as C3, 16 as C4A, 45 as C4B or C, 18 as C5, and 16 as C6. Varicose veins were reported in 273 legs, and lipodermatosclerosis in 79 legs. Subcutaneous calcifications were demonstrated in 35 of 361 legs with CVD in two different locations: the wall of superficial varicose veins and in subcutaneous tissue unrelated to the path of the superficial veins. Superficial veins calcifications were found in 12 of 273 legs with varicose veins (4.4%) and were found in older patients with severe varicose vein disease (grade 3 using the venous clinical severity score and disease duration >30 years). Subcutaneous tissue calcifications (STCs) were found in 24 of 95 legs with a more advanced CVD stage (C4A-C6). No STCs were found in legs with a C1, C2, or C3 class. CONCLUSIONS: Superficial veins calcifications were found only in the legs with severe and long-lasting varicose veins and seemed to be related to chronic severe inflammation of the venous wall. STCs were independent of the vein wall and were found only in the damaged areas of legs with severe CVD (C4-C6). STCs are possibly related to chronic inflammation of the subcutaneous tissue. Their avulsion from the ulcer bed has been recommended to facilitate ulcer healing and prevent recurrence.

The ICC Compression Questionnaire: A Comprehensive Tool to Evaluate Compression Materials or Devices Applied in Subjects with Lymphedema or Chronic Venous Disease.

Background: Compression therapy is an important part of the treatment of patients with lymphedema or chronic venous disease. However, there is no validated questionnaire evaluating the effect of compression and its acceptance by the patient. Therefore, the aims of this study were to construct a questionnaire evaluating the effect of compression and its acceptance by the patient, that is, the Dutch ICC Compression Questionnaire (ICC-CQ), to investigate its reliability and validity, and to translate it into English. Methods and Results: Eleven experts in applying compression and 51 Dutch patients with experience of using compression were involved in the construction process. One part of the ICC-CQ has to be completed by the patient and evaluates seven domains. The other part has to be completed by the health care provider and comprises three domains. Reliability and validity of the final version was investigated in a new group of 79 Dutch-speaking patients with lymphedema or chronic venous disease, wearing compression garments (N = 52) or bandages (N = 27). Except for one domain, the Intraclass Correlation Coefficients for test-rest/interrater reliability ranged from 0.55 to 0.93. Cronbach's alpha for internal consistency ranged from 0.71 to 0.97. Eighty-nine percent of the patients fully understood the questionnaire indicating good face validity, and 87% found it complete indicating good content validity. Construct validity was considered good since 10 out of 11 hypotheses were accepted. Conclusion: The ICC-CQ is the first reliable and valid questionnaire evaluating different kinds of compression and the experience by patients with lymphedema or chronic venous disease.

Effectiveness of Blue light photobiomodulation therapy in the treatment of chronic wounds. Results of the Blue Light for Ulcer Reduction (B.L.U.R.) Study.

BACKGROUND: Lower limb ulcers not responding to standard treatments after 8 weeks are defined as chronic wounds, and they are a significant medical problem. Blue light (410-430 nm) proved to be effective in treating wounds, but there is a lack of data on chronic wounds in clinical practice. The aim of the study was to determine if blue light photobiomodulation with EmoLED (Emoled Srl, Sesto Fiorentino, Florence, Italy) medical device in addition to standard of care is more effective compared to standard of care alone in promoting re-epithelialization of chronic wounds of lower limbs in 10 weeks. METHODS: Ninety patients affected by multiple or large area ulcers were enrolled. To minimize all variabilities, each patient has been used as control of himself. Primary endpoint was the comparison of the re-epithelialization rate expressed as a percentage of the difference between the initial and final area. Secondary endpoints were: treatment safety, pain reduction, wound area reduction trend over time, healing rate. RESULTS: At week 10, the wounds treated with EmoLED in addition to standard care showed a smaller residual wound area compared to the wounds treated with standard of care alone: 42.1% vs. 63.4% (P=0.029). The difference is particularly evident in venous leg ulcers, 33.3% vs. 60.1% (P=0.007). 17 treated wounds and 12 controls showed complete healing at week 10. Patients showed a significant reduction in pain (P=2×10-7). CONCLUSIONS: Blue light treatment in addition to standard of care accelerates consistently the re-epithelialization rate of chronic wounds, especially venous leg ulcers and increases the chances of total wound healing in 10 weeks.

The effects of water immersion and walking on leg volume, ankle circumference and epifascial thickness in healthy subjects with occupational edema.

BACKGROUND: Balneotherapy has been considered beneficial in patients with chronic venous disease due to patient-reported positive outcomes on improvement of symptoms and quality of life.Study aim: Assessing the effects of prolonged water immersion (WI) on leg edema and epifascial thickness and to compare these data with those achieved after continuous walking on ground. MATERIAL AND METHODS: On three consecutive days, 14 otherwise healthy volunteers (9 females, 5 males, mean age 53 ± 10 years) affected by occupational edema (OE), defined as the edema developing during the time period of the working day and disappearing overnight, stayed standing immobile in a swimming pool for 30 minutes (30'), continuously walking again for 30' in the same pool and walking on ground for 30' without interruptions in a randomized sequence. Leg volume, ankle circumference and epifascial thickness of both legs were assessed each day before and after each intervention. RESULTS: Leg volume showed a median reduction by 4.20% (IQR 5-3.6) (p = 0.0002) after 30' of immobile standing immersion and by 6.50% (IQR 7.30-5.61) (P < 0.0001) when the patients walked in the pool. Ankle circumference showed a median reduction by 2.89% (IQR 4.23-2.03) (p = 0.02) with the subjects staying standing still in water and by 5.98% (IQR 7.47-4.14) (p = 0.0002) after 30' walking in the pool. Epifascial thickness showed a median reduction by 24.35% (IQR 35.26-22.5) (P < 0.0001) when the volunteers remained standing still and by 32.66% (IQR 36.91-28-84) (P < 0.0001), when walking in water. Leg volumetry showed a median reduction by 0.20% (IQR-0.44-0.29) (p = 0.375) after walking on ground for 30'. Ankle circumference and epifascial thickness did not show any difference walking on ground compared to baseline situation. CONCLUSIONS: This study showed that 30' of WI, especially when associated with walking, reduced leg volume in otherwise heathy subjects with OE and that walking outside the water did not.

Compression Stocking With 100% Donning and Doffing Success: An Open Label Randomised Controlled Trial.

OBJECTIVE: The aim of this study was to test whether an investigational two layer stocking exerting 27-29 mmHg pressure at the medial supramalleolar level, but without compression in the foot and heel, is easier to put on and take off than a standard stocking of the same compression class (23-32 mmHg), and also to assess the prevention of diurnal oedema with both types of stocking. METHODS: This was an open label randomised controlled trial, which included 47 patients. All participants were at least 65 years of age and suffered from chronic venous disease class C3 - C6 in one leg. The primary end point was donning success; secondary endpoints were doffing success, prevention of diurnal oedema over one day, and the comfort of wearing the stocking. Patients were randomly allocated to one of two groups. Both types of compression stocking were compared in each group for ease of donning and doffing in the manner of a crossover study. Subsequently, patients wore the stocking type assigned to their group for a whole day to evaluate comfort and the effect on diurnal leg volume. RESULTS: All participants were able to don the investigational stocking unaided, compared with 75% for the standard stocking (p < .001). Unaided removal success was 100% with the investigational stocking vs. 66% for the standard stocking (p < .001). There was no significant difference in leg volume reduction between the study groups after a day of wear. The investigational stocking was also rated as being more comfortable than the standard stocking (p < .001). CONCLUSION: The investigational stocking, which has no compression in the foot or heel area, is significantly easier to don and doff, with no inferiority in oedema prevention, compared with a standard stocking of the same compression class.

Compression Therapy Is Not Contraindicated in Diabetic Patients with Venous or Mixed Leg Ulcer.

The aim of this study was to investigate if compression therapy (CT) can be safely applied in diabetic patients with Venous Leg Ulcers (VLU), even when a moderate arterial impairment (defined by an Ankle-Brachial Pressure Index 0.5-0.8) occurs as in mixed leg ulcers (MLU). MATERIALS AND METHODS: in one of our previous publications we compared the outcomes of two groups of patients with recalcitrant leg ulcers. Seventy-one patients were affected by mixed venous and arterial impairment and 109 by isolated venous disease. Both groups were treated by tailored inelastic CT (with compression pressure <40 mm Hg in patients with MLU and >60 mm Hg in patients with VLU) and ultrasound guided foam sclerotherapy (UGFS) of the superficial incompetent veins with the reflux directed to the ulcer bed. In the present sub analysis of the same patients we compared the healing time of 107 non-diabetic patients (NDP), 69 with VLU and 38 with MLU) with the healing time of 73 diabetic patients (DP), 40 with VLU and 33 with MLU. RESULTS: Twenty-five patients were lost at follow up. The results refer to 155 patients who completed the treatment protocol. In the VLU group median healing time was 25 weeks for NDP and 28 weeks in DP (p = 0.09). In the MLU group median healing time was 27 weeks for NDP and 29 weeks for DP (p = -0.19). CONCLUSIONS: when providing leg ulcer treatment by means of tailored compression regimen and foam sclerotherapy for superficial venous refluxes, diabetes has only a minor or no effect on the healing time of recalcitrant VLU or MLU.

The Feasibility of Underwater Computerised Strain Gauge Plethysmography and the Effects of Hydrostatic Pressure on the Leg Venous Haemodynamics.

BACKGROUND: Strain gauge plethysmography (SGP) is employed to evaluate venous drainage of the lower leg. METHODS: In this study, SGP was used to evaluate the effects of the hydrostatic pressure (HP) of water on venous volume (VV), expelled volume, and ejection fraction (EF) in 22 healthy legs before and during immersion in water. RESULTS: HP reduced VV by 100% and even more during underwater (UW) exercise, making calculation of the UW EF possible. DISCUSSION: UW SGP is feasible and indicates that HP improves venous haemodynamics. This study suggests that including UW leg exercise in the rehabilitation protocols of patients with chronic venous disease may be useful. KEYWORDS: Strain gauge plethysmography, Underwater compression, Underwater ejection fraction, Underwater venous volume.

Bioimpedance spectroscopy and volumetry in the immediate/short-term monitoring of intensive complex decongestive treatment of lymphedema.

AIMS: To assess (a) immediate/short-term outcomes of intensive complex decongestive treatment of lower limb lymphedema, by means of bioimpedance spectroscopy and tape measurement-based volumetry, and (b) correlation between these two methods. PATIENTS AND METHODS: Cohort study on patients affected by unilateral primary or secondary lymphedema, stage II or III. Patients underwent complex decongestive treatment (manual and electro-sound lymphatic drainage, compression bandage, exercises, low-carb nutrition, and dietary supplements) for six days. Before (D0), three and six days after complex decongestive treatment (D3 and D6), volumetry and bioimpedance spectroscopy data of the total limb and lower leg were collected. Statistical analysis was applied to pre-post treatment outcomes and to the volumetry/bioimpedance spectroscopy correlation. RESULTS: Forty-one patients (15 males and 26 females, mean age: 50.7 years) were included. A progressive improvement of volumetry and bioimpedance spectroscopy figures was recorded. Total limb and leg volumetry (mean value in cc) was, respectively, 11,072.9 and 3150.8 at D0, 10,493 (-5.2%, p = 0.001) and 2980.2 (-5.4%, p < 0.001) at D6. Total limb lymphatic index at D0 and D6 was 18.9 and 14.8 (-21.5%, p < 0.001). Total limb resistance at D0, D3, and D6 was 200.4, 225.7, and 237.5 (+18.5%, p < 0.001), respectively; leg resistance at D0 and D6 was 117.5 and 150 (+27.7%, p < 0.001), respectively. Total limb reactance at D0, D3, and D6 was 12.2, 15, and 16.6 (+35.5%, p < 0.001), respectively. Leg reactance at D0 and D6 was 7.7 and 11.5 (+ 49.6%, p < 0001), respectively. Correlation volumetry/bioimpedance spectroscopy data were (a) total limb volumetry/resistance rho = -0.449, p < 0.01; volumetry/reactance rho=-0.466, p < 0.01; volumetry/lymphatic index rho = 0.581, p < 0.01; (b) leg volumetry/resistance rho=-0.579, p < 0.01; volumetry/reactance rho=-0.469, p < 0.01; volumetry/lymphatic index rho = 0.466, p < 0.05. CONCLUSIONS: Complex decongestive treatment on lymphedematous limbs was effective at short term; both volumetry and bioimpedance spectroscopy showed a statistically significant improvement. Resistance and reactance increase, with lymphatic index decrease, correlated with volumetry decrease. Bioimpedance spectroscopy proved to help to assess fluid decrease and the tissue-related parameters variations.