A new compression system for treatment of venous leg ulcers: a prospective, single-arm, clinical trial (FREEDOM).

OBJECTIVE: To evaluate the efficacy, tolerability and acceptability of a new multicomponent compression system in one bandage for the local treatment of patients with venous leg ulcers (VLUs). METHOD: This was an international, prospective, non-comparative, clinical trial, conducted in France and Germany. Eligible participants had a VLU with a wound area of 2-20cm2, lasting for a maximum of 24 months. For a period of 6 weeks, patients were treated with a new multicomponent compression system in one bandage which was worn day and night, providing high working pressure and moderate resting pressure (UrgoK1). Clinical assessments, wound measurement and photographs were planned at weeks 1, 2, 4 and 6. The primary endpoint was the relative wound area reduction (RWAR) after 6 weeks of treatment. Secondary endpoints included wound closure rate, oedema resolution, change in patient's health-related quality of life (HRQoL), acceptability, adherence to the compression therapy, local tolerance, and physician's overall satisfaction with the evaluated compression system. RESULTS: A cohort of 52 patients (52% female, mean age 75.4±13.0 years) with VLUs, including oedema in 58% of cases, were recruited from 22 centres. At baseline, 42 patients had already been treated with a different compression system. VLUs had been present for 5.6±4.9 months and had a mean area of 5.7±4.3cm2. After 6 weeks of treatment, a median RWAR of 91% (interquartile range: 39.4; 100.0) was achieved. Wound closure was reported in 35% of patients. A RWAR ≥40% at week 4, predictive of wound healing at 12 weeks, was achieved in 62% of patients. At the final visit, oedema present at baseline was resolved in 57% of patients. Substantial improvements in the HRQoL of the patients were reported with a decrease of the pain/discomfort and anxiety/depression dimensions. Comfort in wearing the evaluated system was reported as 'very good' or 'good' by 79% of patients, resulting in a high patient adherence to compression therapy. Compared to previous compression systems, half of the patients reported more ease in wearing shoes, and greater satisfaction and comfort with this new system. Nine non-serious adverse events related to the device or its procedure occurred in seven patients. At the final visit, the majority of the physicians were 'very satisfied' or 'satisfied' with the new compression system overall. CONCLUSION: The new multicomponent compression system in one bandage has been shown to promote rapid healing of VLUs, reduce oedema, improve HRQoL and to be well tolerated and accepted. It appears to be a viable alternative to existing compression systems.

Limitations to self-management of adjustable compression wraps in the elderly: results of a prospective cohort study.

BACKGROUND: Adjustable compression wraps are used for treating lymphedema and chronic venous insufficiency. These diseases often affect elderly patients with associated pathologies or other limiting factors. These can prevent the self-application of the device by patients on themselves. A better understanding of these factors or the associated pathology in the elderly is important before prescribing or not prescribing a wrap. METHODS: The objective of this prospective cohort study was to determine the main factors that prevent the self-application of the device (Circaid Juxtalite, Medi Italia S.r.l., Bologna, Italy) to the lower limb in the elderly. A private nurse selected the first 30 retired subjects over 65 years of age seen at home for routine nursing care. After a demonstration, she asked them to put on the wrap to reach a pressure of 40 mmHg in the calf (point B1). She recorded the pressures as the subjects applied the wrap twice in a row. The next day, the subject repeated the application of the wrap twice. We considered that an average pressure of more than 30 mmHg is recommended to treat venous edema or ulceration. RESULTS: Thirty percent of the subjects put on the wrap by themselves with an average pressure of at least 30 mmHg. Age is not a limiting factor. Obesity, gripping difficulties, cognitive impairment and low social status seem to be factors limiting the daily self-management of an adjustable compression wrap in the elderly. CONCLUSIONS: The self-management of adjustable compression wraps in the elderly person encounters obstacles that need to be known. The investigation has revealed that obesity, gripping difficulties, cognitive impairment and low social status are limiting factors. Age was not shown to be a limiting obstacle.

Evaluation of TLC-NOSF dressing with poly-absorbent fibres in exuding leg ulcers: two multicentric, single-arm, prospective, open-label clinical trials.

OBJECTIVE: To assess the efficacy, safety and acceptability of a new TLC-NOSF dressing with poly-absorbent fibres in the management of exuding leg ulcers, at the different stages of healing. METHOD: This work presents the results of two prospective, multicentric clinical studies: NEREIDES and CASSIOPEE. Patients with a non-infected, moderate-to-strongly exudating leg ulcer of venous or mixed origin, were treated with the dressing and an appropriate compression system for 12 weeks. The wounds included in NEREIDES had to be in debridement stage, and those in CASSIOPEE at granulation stage. In both studies, the primary outcome was the relative wound area reduction (RWAR) at week 12. Main secondary outcomes included healing rate, time-to-reach wound closure, adverse events and acceptability of the dressing by patients and health professionals. RESULTS: There were 37 patients included in NEREIDES and 51 in CASSIOPEE. The two cohorts presented similar patient and wound characteristics, except from the percentage of sloughy tissue on wound bed at baseline (median: 75% NEREIDES and 30% CASSIOPEE). At week 12, the RWAR (60% NEREIDES and 81% CASSIOPEE), wound closure rates (18% NEREIDES and 20% CASSIOPEE) and mean times-to-reach wound closure (58±27 days NEREIDES and 55±23 days CASSIOPEE) supported the beneficial outcomes of the treatment in both cohorts. In patients with a wound duration ≤6 months, the wound area reduction reached 85% in NEREIDES and 81% in CASSIOPEE, highlighting the importance to initiate adequate treatment as soon as possible. The nature and frequency of the local adverse events were similar in both studies and consistent with the good safety profiles of the poly-absorbent fibres and of the TLC-NOSF dressings. The acceptability of the dressing (easy to apply, conformable and non-adherent to the wound bed at removal, with no pain or bleeding at removal) has been judged 'very good' or 'good' at each stage of the healing process, by both nursing staff and patients. CONCLUSION: These clinical results establish the new TLC-NOSF dressing with poly-absorbent fibres (UrgoStart Plus, Laboratoires Urgo) as an effective, safe and simple treatment for the local management of leg ulcers, at the different stages of healing and until wound closure.

Treatment protocol on stasis edema in poorly mobile nursing home patients.

BACKGROUND: Prolonged immobility in the sitting position in the elderly is known to produce venous stasis with leg edema and possible skin changes. METHODS: The authors have tested a treatment protocol in 30 patients to quantify the reduction of volume caused by an adjustable compression Velcro® wrap (Circaid Juxtalite®, medi GmbH, Bayreuth, Germany) after 15 days and to compare its effect on the leg volume for the next 15 days with 15- to 20-mmHg compression stockings (CS). RESULTS: The authors noted a volume decrease between T0 and T15 by 10.8% (52 legs) under Circaid Juxtalite®. At T30, they observed a non-significant difference between Circaid Juxtalite® (-1%) and the CS (1.3%). CONCLUSIONS: A Velcro® adjustable compression wrap (Circaid Juxtalite®) is efficient in reducing stasis edema in the elderly. Stabilization of the leg volume with the use of 15-20 mmHg CS suggests that a high pressure to maintain results is not required to maintain results.

Evaluation of three different devices to reduce stasis edema in poorly mobile nursing home patients.

BACKGROUND: Prolonged immobility in the sitting position in the elderly is known to produce venous stasis with leg edema and possible skin changes. Compression stockings are often applied for this clinical problem. There is few experienced nursing staff available to supervise the difficult task of stocking application. METHODS: The authors have researched other effective and simple devices that may be suitable alternatives. This article reports the results of three different devices to reduce leg edema, as measured by reduction in leg volume: an electro-stimulation device, an adjustable compression Velcro® wrap and a short stretch bandage, each tested over a two-hour period. RESULTS: In this randomized pilot study including 38 patients, the authors observed no difference in leg volume following electro-stimulation (Veinoplus®). They noted a significant reduction in leg volume following use of the other two devices, more with the adjustable Velcro® wrap compression (Circaid Juxtafit®) than with the short stretch bandage (Rosidal K®). Measurement of the interface pressures created by these two devices and also assessing the stiffness created by applying each device for two hours confirm that pressure is more important than stiffness in the reduction of edema in these particular patients. CONCLUSIONS: This pilot study is to be added to the results of previous published studies showing the efficacy in reducing leg edema of Velcro® adjustable compression wrap and its ease of use.

Prospective randomized controlled study of patient compliance in using a compression stocking: Importance of recommendations of the practitioner as a factor for better compliance.

Background Patient compliance is the cornerstone of compression therapy success. However, there has been up to now no tool to assess it other than self-reporting by the patient, which is not reliable. Material and methods Forty active females classified C2S were enrolled to wear compression stockings (CS) providing a pressure of 15-20 mmHg at the ankle. A thermal probe was inserted in the stocking (Thermotrack®), recording the skin temperature every 20 min for four weeks. The patients were randomized in two groups of 20: - Group 1: Receiving minimal recommendations by their physician at the office. - Group 2: Receiving in-depth recommendations by the physician reinforced with SMS message which were repeated once a week for four weeks. The basic CEAP classification and the quality of life (QoL) were recorded before and after four weeks. Results The two groups are similar for age, symptoms and type of CS. The analysis of the thermal curves showed a significant increase (+33%) in the average wearing time daily in the group 2: 8 h vs. 5.6 h (group1) p < 0.01. The average number of days worn per week is also increased: 3.4 (group 1) vs. 4.8 (group 2), thus improving patient compliance from 48.5% to 70% as a direct result of the physician recommendations ( p < 0.001). Conclusion This is the first study assessing the real compliance in CVD patients of using compression. It shows that better and repeated recommendations by the practitioner result in an increase in time the compression is used by 33%. The study also suggests that the number of days the compression stocking is worn is a good criterion of patient compliance.

Compression versus inner sole for venous patients with foot static disorders: a prospective trial comparing symptoms and quality of life.

OBJECTIVE: To prospectively compare the improvement in quality of life and symptoms achieved when using two treatments-medical compression stockings and inner sole-in subjects with symptomatic chronic venous disease in the presence of foot static disorders. MATERIALS AND METHODS: This prospective study included 24 patients with a symptomatic chronic venous disease associated with foot static disorders. The basic CEAP was used to classify the patients. The venous symptoms were recorded using a 10-point visual analog scale and scored using a customized questionnaire. Patient-reported quality of life data were acquired using a CIVIC questionnaire. A standardized measurement of the Djian-Annonier angle was used to quantify the foot static disorders. We compared the use of the following two treatments: medical compression stockings (18 mm of Hg) and inner sole. For this comparison, we used a crossover technique over 4 successive weeks. RESULTS: One male and 23 female patients were included in this study. We found significant improvement in quality of life scores when only medical compression stockings were used (p < 0.005), only inner sole were used (p < 0.01) and also when both treatments were used together (p < 0.001), compared with no treatment. This was mainly observed for the somatic component of CIVIC. The symptoms of pain, heaviness, swollen feeling, and cramps were significantly improved by the two treatments, whether given separately (p < 0.001) or together (p < 0.0001). No additive effect of the treatments was observed. CONCLUSION: This study suggests that a number of leg symptoms occurring in varicose veins patients are not likely to have a venous origin. They are frequently related to a foot static disorder, which is responsible for postural changes. This study also strongly demonstrates the need for correction of the foot static disorder if such a disorder is present in any patient with chronic venous disease. The use of the inner sole will improve the symptoms and also the quality of life with an efficiency that is almost equal to that provided by the medical compression stockings and the combined use of both treatments is recommended.

Anatomical variations of the femoral vein.

BACKGROUND: The venous anatomy is highly variable. This is due to possible venous malformations (minor truncular forms) occurring during the late development of the embryo that produce several anatomical variations in the number and caliber of the main venous femoral trunks at the thigh level. Our aim was to study the prevalence of the different anatomical variations of the femoral vein at the thigh level. METHODS: This study used 336 limbs of 118 fresh, nonembalmed cadavers. The technique included washing of the whole venous system, latex injection, anatomical dissection, and then painting of the veins. RESULTS: The modal anatomy of the femoral vein was found in 308 of 336 limbs (88%). Truncular malformations were found in 28 of 336 limbs (12%); unitruncular configurations in 3% (axo femoral trunk [1%] and deep femoral trunk [2%]). Bitruncular configurations were found in 9% (bifidity of the femoral vein [2%], femoral vein with axio-femoral trunk [5%], and femoral vein with deep femoral trunk [2%]). CONCLUSION: Truncular venous malformations of the femoral vein are not rare (12%). Their knowledge is important for the investigation of the venous network, particularly the venous mapping of patients with cardiovascular disease. It is also important to recognize a bitruncular configuration to avoid potential errors for the diagnosis of deep venous thrombosis of the femoral vein, in the case of an occluded duplicated trunk.