Ananian CE, Dhillon YS, Van Gils CC, Lindsey DC, Otto RJ, Dove CR, Pierce JT, Saunders MC, et al.
Wound repair and regeneration : official publication of the Wound Healing Society [and] the Eur.... Date of publication 2018 May 1;volume 26(3):274-283.
1. Wound Repair Regen. 2018 May;26(3):274-283. doi: 10.1111/wrr.12645. Epub 2018 Aug
27.
A multicenter, randomized, single-blind trial comparing the efficacy of viable
cryopreserved placental membrane to human fibroblast-derived dermal substitute
for the treatment of chronic diabetic foot ulcers.
Ananian CE(1), Dhillon YS(2), Van Gils CC(3), Lindsey DC(4), Otto RJ(5), Dove
CR(6), Pierce JT(7), Saunders MC(8).
Author information:
(1)New Hope Podiatry, Los Angeles, California, 90063, USA.
(2)Banner University Medical Center, Phoenix, Arizona, 85006, USA.
(3)Foot & Ankle Institute, St. George, Utah 84770, USA.
(4)CHRISTUS St. Vincent Regional Wound and Hyperbaric Center, Santa Fe, New
Mexico 87505, USA.
(5)St. Luke's Clinic - Wound and Hyperbarics, Meridian, Idaho 83642, USA.
(6)Advanced Foot & Ankle Center, Las Vegas, Nevada 89119, USA.
(7)Virginia Mason Medical Center, Federal Way, Washington 98003, USA.
(8)Osiris Therapeutics, Inc., Columbia, Maryland 21046, USA.
Randomized controlled clinical trials, the gold standard to determine treatment
efficacy against control, have demonstrated advantages of skin substitutes for
the treatment of chronic diabetic foot ulcers in comparison to standard of care.
However, randomized controlled clinical trials comparing efficacy between two or
more skin substitutes are very limited. With growing numbers of new skin
substitutes, such studies are essential for treatment and policy-making decisions
by wound care providers and payers. In this study, we analyzed clinical outcomes
and product cost between a viable cryopreserved placental membrane (vCPM) and a
human fibroblast-derived dermal substitute (hFDS) for the treatment of chronic
diabetic foot ulcers in a prospective, multicenter, single-blind study. The
outcomes of 62 patients were analyzed: 31 patients in the vCPM treatment group
and 31 patients in the hFDS treatment group. Utilizing a non-inferiority trial
design and the established treatment regimen of 8 applications for hFDS, we
demonstrated that vCPM was not inferior to hFDS for the proportion of patients
achieving complete wound closure (9.68, 90% CI: [10.67, 28.94]). However,
preliminary findings show that vCPM may have better outcomes for wounds ≤ 5 cm2 :
81.3% (13/16) of wounds in the vCPM group vs. 37.5% (6/16) of wounds in the hFDS
group reached complete closure at the end of treatment (p = 0.0118). A
preliminary product cost analysis for wounds ≤ 5 cm2 may show significant savings
for patients treated with vCPM. Average per-patient costs during the course of
treatment were $3,846 and $7,968 (p < 0.0001) for vCPM and hFDS patients,
respectively. These results may be used as guidance to wound care providers and
payers.
© 2018 The Authors. Wound Repair and Regeneration published by Wiley Periodicals,
Inc. on behalf of by the Wound Healing Society.
DOI: 10.1111/wrr.12645
PMID: 30098272 [Indexed for MEDLINE]
