Cazzell S, Moyer PM, Samsell B, Dorsch K, McLean J, Moore MA, et al.
Advances in skin & wound care. Date of publication 2019 Sep 1;volume 32(9):409-415.
1. Adv Skin Wound Care. 2019 Sep;32(9):409-415. doi:
10.1097/01.ASW.0000569132.38449.c0.
A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex
Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix.
Cazzell S(1), Moyer PM, Samsell B, Dorsch K, McLean J, Moore MA.
Author information:
(1)Shawn Cazzell, DPM, FAPWCA, FAPWH, is Chief Medical Officer, Limb
Preservation Platform, Fresno, California. Peter M. Moyer, DPM, FACFAS, AAPWCA,
is Podiatrist, Purvis Moyer Foot and Ankle Center, Rocky Mount, North Carolina.
At LifeNet Health, Virginia Beach, Virginia, Brian Samsell, BS, is Scientific
Writer; Kimberly Dorsch, BS, CCRP, CRCP, is Director of Global Clinical Affairs;
Julie McLean, PhD, is Senior Manager of Scientific Affairs; and Mark A. Moore,
PhD, is Global Senior Director of Scientific Affairs. Acknowledgments: The
authors thank Collin Smith for data analysis support. This study was funded by
LifeNet Health, a nonprofit organization that processes the studied acellular
dermal matrix. Dr Cazzell and Dr Moyer were among the clinical trial
investigators for this study and received research funding. Mr Samsell, Ms
Dorsch, Dr McLean, and Dr Moore are employees of LifeNet Health. All patient
outcomes were evaluated solely by the investigators to minimize potential for
bias. The authors have disclosed no other financial relationships related to
this article. Submitted January 3, 2019; accepted in revised form March 8, 2019;
published online ahead of print, July 9, 2019.
OBJECTIVE: This prospective, multicenter study evaluated the efficacy and safety
of an acellular dermal matrix allograft, DermACELL (D-ADM; LifeNet Health,
Virginia Beach, Virginia), in the treatment of large, complex diabetic foot
ulcers (DFUs) that probed to tendon or bone.
METHODS: Inclusion criteria were Wagner grade 3 or 4 DFUs between 4 weeks and 1
year in duration. All participants received one application of D-ADM at baseline
and could receive one additional application if wound healing arrested. Ulcers
were assessed weekly for 16 weeks using a laser measuring device.
RESULTS: Sixty-one participants were enrolled, with an average wound area of
29.0 cm; 59 of these ulcers showed exposed bone. The entire per-protocol
population (n = 47) achieved 100% granulation. The mean time to 100% granulation
was 4.0 weeks with an average of 1.2 applications of D-ADM. Mean percent wound
area reduction was 80.3% at 16 weeks. Those DFUs 15 cm or smaller were
substantially more likely to close than DFUs larger than 29 cm (P = .0008) over
a 16-week duration. No complications were associated with the use of the studied
matrix.
CONCLUSIONS: The D-ADM demonstrated the ability to rapidly reduce the size of
large, complex DFUs with exposed bone. Some wounds did not completely heal by 16
weeks; however, the significant reduction in size suggests that these large,
complex wounds may heal if given more time.
DOI: 10.1097/01.ASW.0000569132.38449.c0
PMCID: PMC7328871
PMID: 31361269 [Indexed for MEDLINE]
