Lantis Ii JC, Lullove EJ, Liden B, McEneaney P, Raphael A, Klein R, Winters C, Huynh RN, et al.
Wounds : a compendium of clinical research and practice. Date of publication 2023 Apr 1;volume 35(4):71-79.
1. Wounds. 2023 Apr;35(4):71-79. doi: 10.25270/wnds/22094.
Final efficacy and cost analysis of a fish skin graft vs standard of care in the
management of chronic diabetic foot ulcers: a prospective, multicenter,
randomized controlled clinical trial.
Lantis Ii JC(1), Lullove EJ(2), Liden B(3), McEneaney P(4), Raphael A(5), Klein
R(6), Winters C(7), Huynh RN(8).
Author information:
(1)St. Luke's-Roosevelt Hospital, Vascular/Endovascular Surgery, New York, NY.
(2)West Boca Center for Wound Healing, Coconut Creek, FL.
(3)Surgical Services, Berger Health System, Circleville, OH.
(4)Northern Illinois Foot and Ankle Specialists, Crystal Lake, IL.
(5)Village Podiatry Centers, Smyrna, GA.
(6)Vascular Health Alliance Wound Healing and Hyperbaric Oxygen Center, Georgia,
SC.
(7)Department of Surgery, St Vincent Hospital, Indianapolis, IN.
(8)Rush Medical College, Chicago, I.
INTRODUCTION: DFUs remain a cause of significant morbidity.
OBJECTIVE: This is the third of 3 planned articles reporting on a prospective,
multicenter, randomized controlled trial evaluating the use of omega-3-rich
acellular FSG compared with CAT in the management of DFUs.
MATERIALS AND METHODS: A total of 102 patients with a DFU (n = 51 FSG, n = 51
CAT) participated in the trial as ITT candidates, with 77 of those patients
included in the PP analysis (n = 43 FSG, n = 34 CAT). Six months after
treatment, patients with healed ulcers were followed up for ulcer recurrence. A
cost analysis model was applied in both treatment groups.
RESULTS: The proportion of closed wounds at 12 weeks was compared, as were the
secondary outcomes of healing rate and mean PAR. Diabetic foot wounds treated
with FSG were significantly more likely to achieve closure than those managed
with CAT (ITT: 56.9% vs 31.4%; P =.0163). The mean PAR at 12 weeks was 86.3% for
FSG vs 64.0% for CAT (P =.0282).
CONCLUSIONS: Treatment of DFUs with FSG resulted in significantly more wounds
healed and an annualized cost savings of $2818 compared with CAT.
DOI: 10.25270/wnds/22094
PMID: 37023475 [Indexed for MEDLINE]
