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Science Forum Index » Medicine - Nutrition Forum » Topical Iron Chelation and Diabetic Neuropathic Ulcers...
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| ironjustice... |
 Posted: Wed Jul 02, 2008 2:35 am |
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Talactoferrin alfa, a recombinant human lactoferrin promotes healing
of diabetic neuropathic ulcers : a phase 1/2 clinical study
Auteur(s) / Author(s)
LYONS Thomas E. (1) ; MILLER Michael S. (2) ; SERENA Thomas (3) ;
SHEEHAN Peter (4) ; LAVERY Lawrence (5) ; KIRSNER Robert S. (6) ;
ARMSTRONG David G. (7) ; REESE Amber ( ; YANKEE Ernest W. ( ;
VEVES Aristidis (1) ;
Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)
(1) Beth Israel Deaconess Medical Center and Harvard Medical School,
Palmer 321 A, West Campus, Boston, MA 02215, ETATS-UNIS
(2) The Wound Healing Center, Terre Haute, IN, ETATS-UNIS
(3) Penn North Centers for Advanced Wound Care, Warren, PA, ETATS-UNIS
(4) New York University School of Medicine Hospital for Joint
Diseases, New York, NY, ETATS-UNIS
(5) Scoff and White Hospital, Temple, TX, ETATS-UNIS
(6) University of Miami School of Medicine, Miami, FL, ETATS-UNIS
(7) Scholl's Center for Lower Extremity Ambulatory Research at
Rosalind Franklin University of Medicine and Science, Chicago, IL,
ETATS-UNIS
( Agennix Inc, Houston, TX, ETATS-UNIS
Résumé / Abstract
Background:
Talactoferrin alfa, a recombinant form of human lactoferrin, is a
novel immunomodulatory protein with demonstrated ulcer healing
properties in animal models.
Methods:
A phase 1/2 clinical study was conducted at 7 clinical sites to
determine if talactoferrin can improve wound healing in diabetic
patients with foot ulceration. Fifty-five patients with diabetic
neuropathic foot ulcers participated in this 2-phase study. In phase
1, groups of 3 patients each received open-label 1%, 2.5%, or 8.5%
talactoferrin gel twice daily, in a sequential design, to their ulcer
for 30 days. No drug-related adverse events were found at any dose
level. Phase 2 was a randomized, placebo-controlled, single-blind
study of 2.5% and 8.5% gels, with patients equally divided between the
3 groups. In combination with good wound care, treatment was
administered topically twice daily to the ulcers for 12 weeks. The
primary endpoint was the incidence of ≥75% healing (relative to
baseline size).
Results:
The study, which in phase 2 was powered to detect a difference between
the placebo and combined talactoferrin arms with P <.1, met the
primary objective. The groups receiving the 2.5% (n = 15) and 8.5% (n
= 15) gels had twice the incidence of ≥75% reduction in ulcer size
compared with the placebo group (n = 16): 47%, 53%, and 25%,
respectively. On an intent-to-treat basis, the combination of the 2
active groups when compared with the placebo group showed a strong
trend toward statistical significance (P =.09). There were no
talactoferrin-related adverse events or laboratory abnormalities.
Conclusions:
Topical talactoferrin appears to be safe and well tolerated and
improves healing of diabetic neuropathic ulcers.
Revue / Journal Title
The American journal of surgery ISSN 0002-9610 CODEN AJSUAB
Source / Source
2007, vol. 193, no1, pp. 49-54 [6 page(s) (article)] (18 ref.)
Langue / Language
Anglais
Editeur / Publisher
Elsevier, New York, NY, ETATS-UNIS (1905) (Revue)
Mots-clés anglais / English Keywords
Nervous system diseases ; Endocrinopathy ; Surgery ; Medicine ; Phase
II trial ; Phase I trial ; Ulcer ; Neuropathy ; Healing agent ;
Treatment ; Cicatrization ; Lactoferrin ; Human ; Recombinant
protein ; Diabetes mellitus ;
Mots-clés français / French Keywords
Système nerveux pathologie ; Endocrinopathie ; Chirurgie ; Médecine ;
Essai clinique phase II ; Essai clinique phase I ; Ulcère ;
Neuropathie ; Cicatrisant ; Traitement ; Cicatrisation ;
Lactoferrine ; Homme ; Protéine recombinante ; Diabète ;
Mots-clés espagnols / Spanish Keywords
Sistema nervioso patología ; Endocrinopatía ; Cirugía ; Medicina ;
Ensayo clínico fase II ; Ensayo clínico fase I ; Ulcera ; Neuropatía ;
Cicatrizante ; Tratamiento ; Cicatrización ; Lactoferrina ; Hombre ;
Proteína recombinante ; Diabetes ;
Mots-clés d'auteur / Author Keywords
Talactoferrin ; Diabetes ; Wound healing ;
Localisation / Location
INIST-CNRS, Cote INIST : 5070, 35400014530019.0090
Copyright 2007 INIST-CNRS. All rights reserved
Toute reproduction ou diffusion même partielle, par quelque procédé ou
sur tout support que ce soit, ne pourra être faite sans l'accord
préalable écrit de l'INIST-CNRS.
No part of these records may be reproduced of distributed, in any form
or by any means, without the prior written permission of INIST-CNRS.
Nº notice refdoc (ud4) : 18429369
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