AIM: The aim of this study was to compare the efficacy of Class 1 (10-15 mmHg at the ankle) compression stockings with that of reference stockings of identical appearance during the early stages of chronic venous disease (CVD). METHODS: A prospective multi-center randomized double blind crossover study was conducted on 2 groups of female patients presenting with CVD with a CEAP classification of C1-3SEp As1-5. The efficacy of Class 1 compression stockings was evaluated with respect to global painful discomfort (visual analog scale), each symptom of CVD, the daily behavior of the patient, changes in the volume of the legs, and the functioning of the venous pump (D-PPG). The compliance level of each patient was measured by the number of days that she wore the stockings for at least 6 hours, and tolerance was measured by the reporting of ensuing undesirable events. RESULTS:A total of 125 patients were included in the study and were analyzed for intent to treat. Highly significant differences favoring Class 1 compression stockings were noted with respect to both global painful discomfort and each symptom of CVD with the exception of paresthesia. The relief of symptoms that resulted from the use of the Class 1 compression stockings was twice that which resulted from the use of the reference stockings. Differences that favored the Class 1 compression stockings were also observed with respect to 2 quality-of-life factors (mood and daily work activity). Good compliance in the use of the stockings was reported for 95% of the patients, and tolerance was higher for the Class 1 compression stockings group than for the reference group. CONCLUSION: The regular wearing of Class 1 graduated elastic compression stockings during a 15-day period results in a significant improvement in the symptomatology of early-stage chronic venous disease, i.e., in the relief of global painful discomfort as well as in quality-of-life criteria. A high level of patient compliance in the wearing of the stockings was achieved in this study.
RCT Entities:
AIM: The aim of this study was to compare the efficacy of Class 1 (10-15 mmHg at the ankle) compression stockings with that of reference stockings of identical appearance during the early stages of chronic venous disease (CVD). METHODS: A prospective multi-center randomized double blind crossover study was conducted on 2 groups of female patients presenting with CVD with a CEAP classification of C1-3SEp As1-5. The efficacy of Class 1 compression stockings was evaluated with respect to global painful discomfort (visual analog scale), each symptom of CVD, the daily behavior of the patient, changes in the volume of the legs, and the functioning of the venous pump (D-PPG). The compliance level of each patient was measured by the number of days that she wore the stockings for at least 6 hours, and tolerance was measured by the reporting of ensuing undesirable events. RESULTS: A total of 125 patients were included in the study and were analyzed for intent to treat. Highly significant differences favoring Class 1 compression stockings were noted with respect to both global painful discomfort and each symptom of CVD with the exception of paresthesia. The relief of symptoms that resulted from the use of the Class 1 compression stockings was twice that which resulted from the use of the reference stockings. Differences that favored the Class 1 compression stockings were also observed with respect to 2 quality-of-life factors (mood and daily work activity). Good compliance in the use of the stockings was reported for 95% of the patients, and tolerance was higher for the Class 1 compression stockings group than for the reference group. CONCLUSION: The regular wearing of Class 1 graduated elastic compression stockings during a 15-day period results in a significant improvement in the symptomatology of early-stage chronic venous disease, i.e., in the relief of global painful discomfort as well as in quality-of-life criteria. A high level of patient compliance in the wearing of the stockings was achieved in this study.
Authors: F Pannier; T Noppeney; J Alm; F X Breu; G Bruning; I Flessenkämper; H Gerlach; K Hartmann; B Kahle; H Kluess; E Mendoza; D Mühlberger; A Mumme; H Nüllen; K Rass; S Reich-Schupke; D Stenger; M Stücker; C G Schmedt; T Schwarz; J Tesmann; J Teßarek; S Werth; E Valesky Journal: Hautarzt Date: 2022-04-19 Impact factor: 1.198