Hrev_master Veins and Lymphatics 2017; volume 6:6637 [Veins and Lymphatics 2017; 6:6637] [page 33] Control of lower extremity edema in patients with diabetes: double blind randomized controlled trial assessing the efficacy of mild compression diabetic socks Stephanie C. Wu,1 Ryan T. Crews,1 Melissa Skratsky,1 Julia Overstreet,2 Sai V. Yalla,1 Michelle Winder,1 Jacquelyn Ortiz,1 Charles A. Andersen2 1Center for Lower Extremity Ambulatory Research (CLEAR), Dr. William M. Scholl College of Podiatric Medicine at Rosalind Franklin University of Medicine and Science, North Chicago, IL; 2Madigan Army Medical Center, Tacoma, WA, USA Introduction Lower extremity edema is often an early sign of significant fluid retention that could result in cardiac overload and condi- tions such as heart failure and is a common clinical finding in persons with diabetes.1-3 Persons with type-2 diabetes mellitus espe- cially, have a higher prevalence of peripher- al edema than healthy subjects.4,5 However, the lack of reliable measures to objectively quantify peripheral edema makes it difficult to assess the true prevalence in this popula- tion.6 Once systemic pathology has been managed or ruled out, peripheral edema is most often treated with graduated compres- sion therapy.7-9 However, patients with dia- betes have a 2-5 times greater risk for devel- oping peripheral arterial disease (PAD)10-12 as compared to those without diabetes, and compression therapy has long been consid- ered risky practice in patients with diabetes because of the fear of compromising vascu- larity.13-15 As a result, foot elevation as opposed to graduated compression has gen- erally been recommended to reduce lower extremity edema in diabetic patients, and the diabetic socks currently advocated by healthcare professionals offer either no compression or minimal compression, no greater than 8-15 mmHg, to preemptively guard against exacerbating symptoms of lower extremity PAD. A four-week open label pilot study involving 20 subjects with diabetes and lower extremity edema sug- gested diabetic socks designed to provide mild compression (18-25 mmHg) (Sigvaris Inc, Peachtree City, GA, USA) can be used to decrease lower leg edema without com- promising vascular flow.16 The primary objective of this five week, multi-center, double blind randomized controlled trial was to assess the effectiveness of a diabetic sock that provides mild compression (18-25 mmHg) as compared to a non-compression diabetic sock in patients with both diabetes and lower extremity edema. The secondary objective was to assess the effect of the mild compression diabetic sock versus the non- compression diabetic sock on lower extrem- ity macro and microcirculation. Materials and Methods 80 subjects with LE edema and diabetes were randomized to receive either mild- compression knee high diabetic socks (18- 25 mmHg) or non-compression knee high diabetic socks. Subjects were instructed to wear the socks during all waking hours. Follow-up visits occurred weekly for four consecutive weeks. Edema was quantified through midfoot, ankle, and calf circumfer- ences and cutaneous fluid measurements. Vascular status was tracked via ankle brachial index (ABI), toe brachial index (TBI), and skin perfusion pressure (SPP). Results 77 subjects (39 controls and 38 mild- compression subjects) successfully com- pleted the study. There were no statistical differences between the two groups in terms of age, body mass index, gender, and eth- nicity. Repeated measures analysis of variance and Sidak corrections for multiple compar- isons were used for data analyses. Subjects randomized to mild-compression diabetic socks demonstrated significant decreases in calf and ankle circumferences at the end of treatment as compared to baseline. LE cir- culation did not diminish throughout the study with no significant decreases in ABI, TBI or SPP for either group. Conclusions Results of this RCT suggest that mild compression diabetic socks may be effec- tively and safely used in patients with dia- betes and LE edema. References 1. Eberth-Willershausen W, Marshall M [Prevalence, risk factors and complica- tions of peripheral venous diseases in the Munich population]. Hautarzt 1984;35:68-77. 2. Yu GV, Schubert EK, Khoury WE. The Jones compression bandage. Review and clinical applications. J Am Podiatr Med Assoc 2002;92:221-31. 3. Chantelau E. [Symptom veiled by polyneuropathy. Swollen foot in dia- betes mellitus]. MMW Fortschr Med 2006;148:46-7. 4. Messerli FH. Vasodilatory edema: a common side effect of antihypertensive therapy. Am J Hypertens 2001;14:978- 9. 5. Mudaliar S, Chang AR, Henry RR. Thiazolidinediones, peripheral edema, and type 2 diabetes: incidence, patho- physiology, and clinical implications. Endocr Pract 2003;9:406-16. 6. Brodovicz KG, McNaughton K, Uemura N, et al. Reliability and feasi- bility of methods to quantitatively assess peripheral edema. Clin Med Res Correspondence: Stephanie C. Wu, Center for Lower Extremity Ambulatory Research (CLEAR), Dr. William M. Scholl College of Podiatric Medicine at Rosalind Franklin University of Medicine and Science, North Chicago, IL, USA. E-mail: stephanie.wu@rosalindfranklin.edu Acknowledgments: the study was also partial- ly supported by grant number 2T35DK074390 from the National Institute of Diabetes and Digestive and Kidney Disease. The content is solely the responsibility of the authors and does not represent the official views of the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Funding: the study was funded by a grant from Sigvaris Inc (Peachtree City, GA) the manu- facturer of the mild-compression socks. The sponsor played no role in the conduct of the study, the analysis of the data, nor the drafting of this manuscript. Conflict of interest: the authors declare no potential conflict of interest. Conference presentation: results from the study were previously published in abstract form in: Diabetes 2015;64(S1):A37. doi: 10.2337/db15-1-38. This work is licensed under a Creative Commons Attribution 4.0 License (by-nc 4.0). ©Copyright S.C. Wu et al., 2017 Licensee PAGEPress, Italy Veins and Lymphatics 2017; 6:6637 doi:10.4081/vl.2017.6637 No n c om me rci al us e o nly Conference presentation [page 34] [Veins and Lymphatics 2017; 6:6637] 2009;7:21-31. 7. Armstrong DG, Nguyen HC. Improvement in healing with aggressive edema reduction after debridement of foot infection in persons with diabetes. Arch Surg 2000;135:1405-9. 8. Gardner AMN, Fox RH. The return of blood to the heart: venous pumps in health and disease. London: John Libbey; 1989. 9. Gaskell P, Parrott JCW. The effect of a mechanical venous pump on the circu- lation of the feet in the presence of arte- rial obstruction. 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Safety and efficacy of mild compres- sion (18-25 mm Hg) therapy in patients with diabetes and lower extremity edema. J Diabetes Sci Technol 2012;6:641-7. No n c om me rci al us e o nly