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纺织科学与工程学报

Randomized Placebo−Controlled Clinical Trial of Gloves and Stockings Made from Infrared−Emitting Fabric (Celliant®) for Transcutaneous Oxygen and Peripheral Blood Flow in Diabetic Patients with Vascular Impairment

Abstract

Lawrence A. Lavery* Kathryn Davis Seth Casden and Michael R Hamblin

Objective: To evaluate changes in transcutaneous oxygen (TcPO2) and peripheral blood flow (laser Doppler, LD) in the hands and feet of diabetic patients with vascular impairment when Celliant gloves and stockings are worn.

Methods: We enrolled 20 subjects with a history of diabetes and vascular impairment to be monitored by TcPO2 and LD in the hand and foot at 10-minute intervals over the course of a 1hr treatment with Celliant or placebo gloves and stockings that were applied at the same time but in different sequences with a 1hr interval. The tester and subject were blinded to the type of study garment.

Results: There were no statistically differences between measurements due to the small sample size and variability in the data. However there was a trend for increasing TcPO2 and LD particularly in the foot when comparing placebo garments (first) and Celliant garments (second) at time periods of 50 and 60 minutes.

Conclusion: The 1hr wearing time may have been insufficient for the full effect to be observed, and the 1hr interval between the different garments may be too short to washout the Celliant effect, when the placebo garments were applied second. Further studies are necessary to obtain statistically significant results, and to determine whether Celliant garments could prevent diabetic foot complications.

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