Prospective Evaluation of the Safety and Compression Performance of Novel Compression Denim Jeans in Healthy Volunteers and Patients With Lymphedema

Abstract

Objectives: The treatment of lower-extremity lymphedema, whether congenital or acquired, remains challenging. Long-term management aimed at reducing complications and maximizing quality of life is essential. Compression stockings are crucial in this management; however, their application is limited by patient experience (ease of wear, texture, breathability, and appearance). This highlights the need to evaluate alternative compression garments that maintain therapeutic efficacy while improving patient adherence.

Methods: We developed a novel compression denim product (Flow plus Jeans®) using advanced sewing technology. Its baseline performance (compression ability) was evaluated by measuring pressure gradients at three points (ankle, calf, and thigh) using a mannequin-based compression testing system and compared with those of existing stockings. Thereafter, a safety assessment was conducted on healthy volunteers to evaluate potential adverse effects, including changes in lower limb circumference, signs of deep vein thrombosis (DVT) via ultrasound, and skin complications. A clinical trial in patients with lymphedema was then performed to compare its efficacy with that of conventional compression stockings.

Results: Baseline performance testing with a mannequin revealed that Flow plus Jeans demonstrated compression levels and pressure gradients at three calf points comparable to those of standard compression stockings. A safety study involving nine healthy volunteers confirmed that Flow plus Jeans caused no significant changes in lower-limb circumferences after three days of wear, with no cases of DVT or skin complications. In a subsequent clinical trial involving nine female patients with lymphedema, the jeans showed non-inferiority to existing stockings concerning lower-limb circumference measurements at six points (pre-use vs. six months post-use), with patient-reported experiences assessed via questionnaires. Notably, patients reported enhanced satisfaction regarding the jeans' fashionability, which could serve as an incentive for long-term adherence.

Conclusion: Our findings suggest that Flow plus Jeans represent a promising novel option for the long-term management of lymphedema, offering an alternative that balances medical efficiency with improved patient satisfaction and demonstrates safety in healthy individuals.

Keywords: compression garments; denim jeans; long-term management; lower-extremity lymphedema; quality of life.

Figure 1. Development of denim-style compression jeans using novel sewing technology

(A) Overview of Flow plus Jeans® developed using proprietary sewing technology (patent granted). The jeans appear identical to standard stretch jeans but are tailored to provide a graduated compression effect, with pressure gradually decreasing from the ankle to the abdomen. (B) Photographs demonstrating the appearance and fit of Flow plus Jeans® when worn. The jeans resemble standard skinny jeans while incorporating a graduated compression function designed for lymphedema management. These images provide a visual reference for the product’s integration into everyday wear. (C) Results of compression gradient testing using a mannequin. Pressure sensors placed at three points on the lower leg measured compression forces for Flow plus Jeans® and conventional medical compression stockings. (D) Both products exhibit a gradual decrease in compression pressure from the ankle toward the proximal side. Statistical analysis using a t-test showed no significant differences between the two groups at any measurement point. p < 0.01: comparison to the ankle within each group (n = 3). This figure represents the within-group comparisons of ankle vs. distal to the calf and ankle vs. posterior calf for each group separately. The asterisk (*) indicates significant differences in these within-group comparisons (p < 0.01). Error bars indicate standard deviation (SD).

Figure 2. Safety evaluation of Flow plus Jeans® in healthy participants

A study was conducted in nine healthy individuals to primarily assess the safety of Flow plus Jeans®. The lower image presents changes in lower-limb circumferences at the ankle (⑪), calf (⑦), and thigh (⑲) before wearing and after three days of use. No significant changes in limb circumference were observed at any measurement site. Statistical analysis was performed using a paired t-test, and no significant differences were detected between pre-use and post-use measurements (p > 0.05).

Figure 3. Assessment of conventional medical compression stockings in study participants with lymphedema

Changes in circumferences from the abdomen to the lower limbs before and after six months of compression therapy using conventional medical stockings in nine patients with lymphedema (A–I). Measurements were taken at six points (①, ②, ③, ⑤, ⑦, and ⑨). Statistical analysis using a paired t-test showed no significant increases in circumference between pre-treatment and six-month follow-ups (p > 0.05), indicating that compression therapy effectively managed lymphedema without worsening.

Figure 4. Assessment of Flow plus Jeans® in study participants with lymphedema

Changes in circumferences from the abdomen to the lower limbs before and after six months of compression therapy using Flow plus Jeans® in nine lymphedema patients (A–I) are shown. Measurements were taken at six points (①, ②, ③, ⑤, ⑦, and ⑨). Statistical analysis using a paired t-test showed no significant increases in circumference between pre-treatment and six-month follow-ups (p > 0.05), indicating that compression therapy effectively managed lymphedema without worsening.

Figure 5. User experience survey comparing Flow plus Jeans® and conventional medical compression stockings

(A, B) Results of questionnaires assessing user experience with conventional medical stockings and Flow plus Jeans® immediately after use (pre) and after six months (pre: n = 9, 6 months: n = 8). Among the seven evaluated parameters, statistical analysis using an unpaired t-test showed that Flow plus Jeans® had significantly higher satisfaction in terms of fashionability than stockings at both pre-treatment and six months (*p < 0.05). However, Flow plus Jeans® was significantly inferior to stockings in terms of ease of wear at both pre-treatment and six-month time points (*p < 0.05).

Figure 6. Japanese Questionnaire Page 1

Figure 7. Japanese Questionnaire Page 2

Figure 8. Japanese Questionnaire Page 3

Figure 9. Japanese Questionnaire Page 4

Figure 10. Questionnaire translated into English Page 1

Figure 11. Questionnaire translated into English Page 2

Figure 12. Questionnaire translated into English Page 3

Figure 13. Questionnaire translated into English Page 4