Lakewood-Amedex, Inc. faʻasalalau i le asō ua amata lana suʻesuʻega lona lua o le Vaega 2 e faʻaaoga ai le Bisphosphocin Nu-3 antimicrobial i le togafitia o tagata mamaʻi e maua i le maʻisuka vae (DFU). E sili atu i le 34 miliona tagata matutua i le Iunaite Setete e maua i le maʻi suka (Source: CDC), ma o faʻalavelave a le DFU e nafa ma le tusa ma le 85% o le tipiina o pito pito i lalo e le faʻaleagaina i le tausaga, ma faʻatupuina ai se faʻamaʻi mataʻutia, maliu, ma avega tau tupe faiga tau soifua maloloina.
Ole su'esu'ega ole Vaega 2 ole su'esu'ega fa'asolosolo, tele-center, lua-tauaso, placebo-controlled, dose-escalating su'esu'ega e iloilo ai le saogalemu ma le fa'amalieina ole fa'aogaina ole Bisphosphocin Nu-3 gel ile ma'isuka ituaiga I po'o II ma le DFU tumau. I asiasiga uma ile falema'i, ole a su'esu'eina le papala ole ma'i mo so'o se suiga ile vaega ma ole a su'esu'eina le loloto ole papala ma le pulea ole microbiological.
Steve Parkinson, Peresetene & Pule Sili o Lakewood-Amedex, fai mai, "Matou te matua fiafia lava i le amataina o le matou suesuega lona lua i le togafitia o DFUs. I la matou aafiaga talu ai i le iloiloina o le Nu-3 mo le togafitia o tagata mamaʻi o loʻo aʻafia i le maʻisuka vae maʻisuka, Nu-3 na faʻafeiloaʻi lelei e aunoa ma ni mea leaga na lipotia e fesoʻotaʻi ma togafitiga. E ui e le'i fa'amalosia lenei su'esu'ega fa'atupula'ia fa'afuainumera e fa'atupuina fa'amaumauga taua tele, ae na fa'aalia ai le fa'alototeleina o le malosi. O ma'i na togafitia i le 2% Nu-3 solution mo aso e fitu e 65.5% le fa'aitiitia o le vaega o le ma'i ma'i fa'asaga i le 29.9% le fa'aitiitiga i le placebo lima, e pei ona fuaina i le 14 aso talu ona amata togafitiga. E le gata i lea, o le 62.5% o tagata gasegase na togafitia i le 2% Nu-3 na vaʻaia le faʻaitiitia o le uta microbiological, faʻatusatusa i le 20% i le placebo. O le taimi nei o la matou Vaega 2 o le faʻalauteleina o suʻesuʻega o le a fausia i luga o le faʻavae o faʻataʻitaʻiga faʻataʻitaʻi muamua e ala i le faʻaaogaina o se togafitiga umi o le 28 aso, o le maualuga maualuga o le 5% sosoo ai ma le 10% Nu-3, faʻapea foʻi ma le faʻaleleia o le Nu-3. gel faʻatulagaina, o mea uma matou te faʻamoemoeina o le a ofoina atu le tuʻuina atu lelei o Nu-3 ma togafitiga o manuʻa e le faʻamalolo. O le a'afiaga o fa'ama'i pipisi ma fa'ama'i pipisi o lo'o tumau pea se avega mamafa i le faiga o le soifua maloloina. Matou te talitonu o la matou tautinoga e faʻalautele le atinaʻeina o la matou faʻavae, antimicrobial Bisphosphocins tekinolosi faʻatasi ma le lelei, faʻaogaina faʻapitonuʻu o faʻamaʻi pipisi, e masani ona mafua mai i siama faʻamaʻi faʻamaʻi, e lua gram-positive ma gram-negative, o le a mafai ai e le au tausi soifua maloloina ona sili atu le saogalemu ma le faʻaogaina lelei. le tele o faʻamaʻi pipisi o loʻo faʻamaonia i le taimi nei le luʻitau i le faʻaaogaina o auala masani."
“O Dr. Felix Sigal, o ia o se tasi o tagata tomai faapitoa iloga i le vaega o le maʻisuka limb salvage, o loʻo galue i le Hollywood Presbyterian Medical Center ma le California Hospital Medical Center. Na te taulaʻi i le tausiga o manuʻa ma le faʻasaoina o lima o le maʻisuka, aʻo tulituliloaina lona fiafia i suʻesuʻega falemaʻi ina ia mafai ai ona sili atu togafitiga mo ana gasegase. Matou te fiafia e taʻu atu o Dr. Sigal ua uma ona lesitalaina le tagata maʻi muamua i lenei Vaega 2 suʻesuʻega e iloilo ai le faʻaogaina o le Nu-3 gel i le togafitiga o maʻi vae maʻisuka, "o le tala lea a Sumita Paul, MD, MPH, MBA, Fomaʻi Sili. & Sui Peresetene Sinia o Su'esu'ega & Atina'e i Lakewood-Amedex Inc. "O le ai ai le 12 gasegase e togafitia i le Nu-3 gel i vaega ta'itasi e lua ma fa'atasi ai ma se vaega la'ititi e togafitia i le placebo."
OA MEA E AVEA MAI LENEI TUSI:
- Now our Phase 2 dose-escalating study will build on the foundation of the previous clinical trials by using a longer treatment duration of 28 days, a higher concentration of 5% followed by 10% Nu-3, as well as an improved Nu-3 gel formulation, all of which we expect will offer a better delivery of Nu-3 and treatment of nonhealing wounds.
- The Phase 2 study is a randomized, multi-center, double-blind, placebo-controlled, dose-escalating study to evaluate the safety and tolerability of topically applied Bisphosphocin Nu-3 gel on Type I or II diabetes mellitus patients with chronic DFU.
- Felix Sigal, who is one of the most distinguished specialists in the field of diabetic limb salvage, is on staff at both the Hollywood Presbyterian Medical Center and the California Hospital Medical Center.
