Unit:
Library of the School of Health SciencesΠΜΣ Σακχαρώδης Διαβήτης και Παχυσαρκία
Author:
Tentolouris Anastasios
Supervisors info:
Τεντολούρης Νικόλαος, Αναπληρωτής Καθηγητής, Ιατρική, ΕΚΠΑ
Μακρυλάκης Κωνσταντίνος, Αναπληρωτής Καθηγητής, Ιατρική, ΕΚΠΑ
Κόκκινος Αλέξανδρος, Αναπληρωτής Καθηγητής, Ιατρική, ΕΚΠΑ
Original Title:
Νέα μέθοδος αντιμετώπισης των χρόνιων διαβητικών ελκών, βασισμένη στη θεραπεία με RGTA matrix: μία τυχαιοποιημένη, ελεγχόμενη μελέτη
Translated title:
New method of treating chronic diabetic ulcers, based on RGTA matrix therapy: a randomized, controlled study
Summary:
Ulcers are a common complication of diabetes mellitus (DM). In diabetic ulcers, there is increased activity of proteins that disrupt the extracellular matrix (ECM) and impair wound healing. Matrix therapy regenerating agents (RGTA) (CACIPLIQ) are chemically formulated polymers specifically designed to replace heparin sulfate in ulcers and thereby mimic its action by protecting ECM proteins. The aim of this study was to evaluate the efficacy and safety of CACIPLIQ in chronic neuropathic diabetic ulcers.
A total of 27 patients with DM and active foot neuropathic ulcer lasting >6 weeks were recruited. The duration of the study was 16 weeks; the first visit was 2 weeks before the intervention and the last visit was 4 weeks after the end of the intervention. A total of 13 of these patients were randomized to standard care and 14 to CACIPLIQ via spraying as add on standard care.
The patients of the two groups did not differ significantly in their demographic, clinical and laboratory characteristics at baseline. No significant difference was found between the two groups regarding the primary endpoint (number of ulcers with >80% reduction in ulcer size 10 weeks after administration of CACIPLIQ) (P = 0.936). Additionally, there was no statistically significant difference in secondary endpoints, including adverse events.
In conclusion, the addition of CACIPLIQ to standard wound care in neuropathic diabetic foot ulcers does not impact wound healing in comparison with the standard wound care.
Main subject category:
Health Sciences
Keywords:
Diabetes mellitus, Diabetic foot, Diabetic ulcer, Cacipliq
Number of references:
115
