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Control of lower extremity edema in patients with diabetes: Double blind randomized controlled trial assessing the efficacy of mild compression diabetic socks.

ABSTRACT: AIMS:Persons with diabetes frequently present with lower extremity (LE) edema; however, compression therapy is generally avoided for fear of compromising arterial circulation in a population with a high prevalence of peripheral arterial disease. This double blind randomized controlled trial (RCT) assessed whether diabetic socks with mild compression could reduce LE edema in patients with diabetes without negatively impacting vascularity. METHODS:Eighty subjects with LE edema and diabetes were randomized to receive either mild-compression knee high diabetic socks (18-25mmHg) 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 circumferences and cutaneous fluid measurements. Vascular status was tracked via ankle brachial index (ABI), toe brachial index (TBI), and skin perfusion pressure (SPP). RESULTS:Seventy-seven subjects (39 controls and 38 mild-compression subjects) successfully completed the study. No statistical differences between the two groups in terms of age, body mass index, gender, and ethnicity. Repeated measures analysis of variance and Sidak corrections for multiple comparisons 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 circulation 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 effectively and safely used in patients with diabetes and LE edema.

SUBMITTER: Wu SC

PROVIDER: S-EPMC5429175 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Control of lower extremity edema in patients with diabetes: Double blind randomized controlled trial assessing the efficacy of mild compression diabetic socks.

Wu Stephanie C SC Crews Ryan T RT Skratsky Melissa M Overstreet Julia J Yalla Sai V SV Winder Michelle M Ortiz Jacquelyn J Andersen Charles A CA

Diabetes research and clinical practice 20170227

<h4>Aims</h4>Persons with diabetes frequently present with lower extremity (LE) edema; however, compression therapy is generally avoided for fear of compromising arterial circulation in a population with a high prevalence of peripheral arterial disease. This double blind randomized controlled trial (RCT) assessed whether diabetic socks with mild compression could reduce LE edema in patients with diabetes without negatively impacting vascularity.<h4>Methods</h4>Eighty subjects with LE edema and d ...[more]

PMID: 28315576

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Project description:BackgroundClimacteric women experience various disorders, including hot flush, depression, insomnia, arthralgia, and hand and foot numbness. Dangguijakyaksan is among the most common treatments for climacteric syndrome, and its effect on depression, insomnia, hot flush and quality of life (QOL) in climacteric women has been reported multiple times. A recent animal study found dangguijakyaksan decreased serum lipid factors and improved blood circulation in a menopausal rat model; however, these effects have not been assessed in clinical trials. This study aims to assess the clinical effects and safety of dangguijakyaksan for lower-extremity blood circulation disturbances in climacteric women.MethodsThis is a single-center, randomized, double-blinded, placebo-controlled pilot study that will be conducted at Dunsan Korean Medicine Hospital at Daejeon University. Forty-six climacteric women with lower-extremity blood circulation disturbances will be recruited and randomized (1:1) into either the dangguijakyaksan or placebo group. After 8 weeks of administration, the effects and safety of dangguijakyaksan will be assessed.The primary outcome is the visual analogue scale for lower-extremity blood circulation disturbances, and it will be assessed on visits 1, 2, and 3. The secondary outcomes, Kupperman's index and blood deficiency scoring system, will be assessed on visits 1, 2, and 3, and accelerated photoplethysmography and digital infrared thermal imaging will be performed on visits 1 and 3. Moreover, blood lipid profile, follicle-stimulating hormone, and estradiol levels will be measured at the screening visit and visit 3. Blood tests will be performed at the screening visit and visit 3 to assess the safety of dangguijakyaksan. Statistical analysis will be performed using R-3.3.3 (Another Canoe), and within-group study variable differences after drug administration will be analyzed using paired t-test or Wilcoxon signed-rank test.DiscussionWe expect to confirm the effects and safety of dangguijakyaksan on lower-extremity blood circulation disturbances in menopause, which would provide foundational data for planning subsequent studies.

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Dataset Information

Control of lower extremity edema in patients with diabetes: Double blind randomized controlled trial assessing the efficacy of mild compression diabetic socks.

Publications

Control of lower extremity edema in patients with diabetes: Double blind randomized controlled trial assessing the efficacy of mild compression diabetic socks.

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