Frykberg RG, Cazzell SM, Arroyo-Rivera J, Tallis A, Reyzelman AM, Saba F, Warren L, Stouch BC, Gilbert TW, et al.
Journal of wound care. Date of publication 2016 Jul 1;volume 25 Suppl 7():S18-25.
1. J Wound Care. 2016 Jul;25 Suppl 7:S18-25. doi: 10.12968/jowc.2016.25.7.S18.
Evaluation of tissue engineering products for the management of neuropathic
diabetic foot ulcers: an interim analysis.
Frykberg RG(1), Cazzell SM(2), Arroyo-Rivera J(3), Tallis A(4), Reyzelman AM(5),
Saba F(6), Warren L(7), Stouch BC(8), Gilbert TW(9).
Author information:
(1)Carl T. Hayden Phoenix VA Medical Center, Phoenix, AZ.
(2)Valley Vascular Surgery Associates, Fresno, CA.
(3)Advanced Research Institute of Miami, Homestead, FL.
(4)Associated Foot & Ankle Specialists, PC, Phoenix, AZ.
(5)Center for Clinical Research Inc., Castro Valley, CA.
(6)Professional Health Care of Pinellas, St. Petersburg, FL.
(7)NewPhase Clinical Trials, Corp., Miami Beach, FL.
(8)The Philadelphia College of Osteopathic Medicine, Philadelphia, PA.
(9)ACell, Inc., Columbia, MD.
OBJECTIVE: The objective of this prospective, multicentre clinical study is to
assess the application of MatriStem MicroMatrix (MSMM) and MatriStem Wound Matrix
(MSWM) (porcine urinary bladder derived extracellular matrix) compared with
Dermagraft (DG) (human fibroblast-derived dermal substitute) for the management
of non-healing diabetic foot ulcers (DFUs).
METHOD: A randomised, multicentre study was conducted at thirteen centers
throughout the US. It was designed to evaluate the incidence of ulcer closure,
rate of ulcer healing, wound characteristics, patient quality of life,
cost-effectiveness, and recurrence. Those subjects whose DFUs decreased in size
by ≤30% or increased by ≤50% during the standard of care (SOC) phase were
randomised into the treatment phase of the study. The study evaluated complete
wound closure by eight weeks with weekly device application. A two-week post
treatment SOC phase followed the treatment phase for any wounds that did not heal
by the end of eight weeks, and wound closure was also evaluated at the end of
that period. Ulcer recurrence at 6 months post-treatment was evaluated in the
subjects that showed wound healing by the end of the post-treatment SOC phase.
Standard adjunctive therapy, including debridement, saline irrigation and foot
off-loading, was provided to both arms during the four-week screening period,
after which eligible subjects were randomised in a 1:1 ratio, to either the
MatriStem (MS) or DG treatment arm. This study was developed to evaluate the
hypothesis that the wound outcomes observed after wound management with MS were
non-inferior to those of DG after eight weeks. The authors present the planned
interim results of this study after one half of the projected enrolment was
completed.
RESULTS: There were 95 subjects consented and entered into the SOC four-week
screening phase of the trial and 56 were randomised into the treatment phase. At
the planned interim analysis, there was a significantly lower cost per subject
and significant improvement in patient quality of life for the subjects treated
with MS compared with those managed with DG. However, there was not a
statistically significant difference found during the analysis of the interim
data between the two study groups for rate of wound healing or number of subjects
with complete wound closure.
CONCLUSION: The data from this interim analysis show that MSMM and MSWM provide
results for healing DFUs that are similar to the results obtained for DG at a
significant quality of life and economic advantage.
DOI: 10.12968/jowc.2016.25.7.S18
PMID: 27410467
