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Advantages and disadvantages of graduated and inverse graduated compression hosiery in patients with chronic venous insufficiency and healthy volunteers: a prospective, mono-centric, blinded, open randomised, controlled and cross-over trial
Riebe H, Konschake W, Haase H, Junger M
Phlebology 2018 Feb;33(1):14-26
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: Yes; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: The therapeutic effectiveness of compression therapy depends on the selection of compression hosiery. OBJECTIVES: To assess efficacy and tolerability of graduated elastic compression stockings (GECS) and inverse graduated elastic compression stockings (PECS). METHODS: Thirty-two healthy volunteers and thirty-two patients with chronic venous insufficiency were analysed; wear period: one week for each stocking type (randomised, blinded). Primary outcome: volume reduction of 'lower leg' (Image3D) and 'distal leg and foot' (water plethysmography). Secondary outcomes: clinical symptoms of chronic venous insufficiency assessed by the Venous Clinical Severity Score, side effects and wear comfort in both groups. RESULTS: Volume of lower leg': significant reduction in healthy volunteers (mean GECS -37.5 mL, mean PECS -37.2 mL) and in patients (mean GECS -55.6 mL, mean PECS -41.6 mL). Volume of 'distal lower leg and foot': significant reduction in healthy volunteers (mean GECS -27 mL, mean PECS -16.7 mL), significant reduction in patients by GECS (mean -43.4 mL), but non-significant reduction by PECS (mean -22.6 mL). Clinical symptoms of chronic venous insufficiency were improved significantly better with GECS than with PECS, p < 0.001. GECS led to more painful constrictions, p = 0.047, PECS slipped down more often, p < 0.001. CONCLUSION: GECS and PECS reduce volume of the segment 'lower leg' in patients and healthy volunteers. Patients' volume of the 'distal lower leg and foot', however, were diminished significantly only by GECS (p = 0.0001). Patients' complaints were improved by both GECS and PECS, and GECS were superior to PECS.

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