Effects of the use of bioceramic wraps in patients with lower limb venous ulcers:A randomized double-blind placebo-controlled trial

Background:Venous ulcer represents the most advanced stage of chronic venous insufficiency.It is an important public health problem and has a significant impact on patients’quality of life due to chronic pain,inability to work,need for hospitalization and frequent outpatient follow-up.Objective:We investigated the treatment benefits of far-infrared ceramic(cFIR),in a 90-day study of lower limb venous ulcers and looked at ulcer healing scores,quality of life,serum bio-markers of oxidative stress and antioxidant defense enzymes.Design,setting,participants and interventions:This is a randomized double-blind placebo-controlled study conducted in the Vascular Surgery Service of a hospital located in the northwest region of the State of Rio Grande do Sul,Brazil.We included patients with lower limb venous ulcers who were randomized to use either a bioceramics wrap or a placebo wrap for 90 days.Main outcome measures:The following evaluations were conducted at baseline and after 15,30,60 and90 days:ulcer healing score,quality of life,and serum markers of oxidative stress and antioxidant enzyme activity.Results:Patients(n=24)with lower limb venous ulcers were randomized into two treatment groups.cFIR decreased the ulcer size on day 30(P=0.042)and 90(P=0.034)and the total ulcer healing scale scores on day 30(P=0.049)and 90(P=0.02)of the treatment,when compared to baseline.Additionally,cFIR improved tissue type(epithelial tissue)on day 60(P=0.022)when compared to baseline evaluation.Conclusion:cFIR clinically improved ulcer healing in patients with lower limb venous ulcers.Trial registration:RBR-8c7xzn on ReBEC.

Far infrared-emitting ceramics decrease Freund's adjuvant-induced inflammatory hyperalgesia in mice through cytokine modulation and activation of peripheral inhibitory neuroreceptors

Objective： The present study aimed to evaluate the analgesic and anti-inflammatory effects of far infrared-emitting ceramics （cFIRs） in a model of persistent inflammatory hyperalgesia and to elucidate the possible mechanisms of these effects. Methods： Mice were injected with complete Freund＇s adjuvant （CFA） and treated with cFIRs via place- ment on a pad impregnated with cFIRs on the bottom of the housing unit for different periods of time. Mice underwent mechanical hyperalgesia and edema assessments, and tumor necrosis factor-α （TNF-α）, interleukin-1β （IL-1β） and IL-10 levels were measured. Twenty-four hours after CFA injection and 30 min before cFIR treatment, mice were pretreated with a nonselective adenosinergic antagonist, caffeine, the selective adenosine receptor A antagonist, 1,3-dipropyl-8-cyclopentylxanthine （DPCPX）, the selective cannabinoid receptor type 1 antagonist, AM281, the selective cannabinoid receptor type 2 antagonist, AM630, or the nonselective opioid receptor antagonist, naloxone, and mechanical hyperalge- sia was assessed. Results： cFIRs statistically （P 〈 0.05） decreased CFA-induced mechanical hyperalgesia （82.86 ±5.21）% in control group vs （56.67±9.54）% in cFIR group） and edema （（1699.0 ± 77.8） gm in control group vs （988.7±107.6） gm in cFIR group）, cFIRs statistically （P 〈 0.05） reduced TNF-α （0.478± 0.072） pg/mg of protein in control group vs （0.273 ±0.055） pg/mg of protein in cFIR group） and IL-113 （（95.81 ± 3.95） pg/mg of protein in control group vs （80.61 ±4.71）pg/mg of protein in cFIR group） levels and statistically （P〈 0.05） increased IL-10 （（18.32 ±0.78） pg/mg of protein in control group vs （25.89 ±1.23） pg/mg of protein in cFIR group） levels in post-CFA-injected paws. Peripheral pre-administration of inhibitory neuroreceptor antagonists （caffeine, DPCPX, AM281, AM630 and naloxone） prevented the analgesic effects of cF1Rs （P 〈 0.05）.Conclusion： These data provide additional support for the use of cFIRs in the treatment of painful inflam- matory conditions and contribute to our understanding of the neurobiological mechanisms of the ther- apeutic effects of cFIRs.