Evaluation of a Novel Class 2 Graduated Elastic Compression Garment Compared to a Gold Standard Compression Garment

Background: Graduated elastic compression stockings are a frequently prescribed therapy for cardiovascular conditions with established benefit. However patient compliance remains low owing to significant difficulty donning the device, discomfort and poor fit. Based on end-user feedback, a novel compression device (CompressRite CR) to facilitate one handed application with minimal use of upper extremity strength was compared to Jobst stocking (Control). Methods: An open, prospective, single-center study was done in in volunteers and in-patients. Study subject’s lower extremities were clinically classified by a blinded vascular specialist. Pressure readings were obtained using a pressure sensor in standing position every 5 minutes during two 30-minute sessions using CR and Control. Results: Ninety study subjects (82 healthy volunteers, 8 in-patients, 34% males, 66% females, 70% White, 22% African American, %7 Asian, 1% Hispanic) completed the study. Clinical vascular classification revealed 31% C0, 18% C3, 16% C1, 7% C2, 4% C4 and 22% unclassified. CR performed similar to Control in terms of pressure delivery. Calf circumference was not impacted by pressure sessions in both groups. Application time of CR was higher but removal times were similar. Qualitative feedback collected showed that CR was superior to conventional garment. Conclusion: CR appeared to be equally effective to Control graduated elastic stockings with a longer application time on first attempt but consistently higher scores for satisfaction. This may represent an attractive alternative with higher patient compliance rates.