Alvarez OM, Smith T, Gilbert TW, Onumah NJ, Wendelken ME, Parker R, Markowitz L, et al.
Wounds : a compendium of clinical research and practice. Date of publication 2017 Feb 27;volume ():.
1. Wounds. 2017 Feb 27. pii: WNDS20170227-1. [Epub ahead of print]
Diabetic Foot Ulcers Treated With Porcine Urinary Bladder Extracellular Matrix
and Total Contact Cast: Interim Analysis of a Randomized, Controlled Trial.
Alvarez OM(1), Smith T(2), Gilbert TW(3), Onumah NJ(4), Wendelken ME(2), Parker
R(2), Markowitz L(2).
Author information:
(1)Center for Curative and Palliative Wound Care, Calvary Hospital, Bronx, NY and
Department of Medicine, New York Medical College, Valhalla, NY.
(2)Center for Curative and Palliative Wound Care, Calvary Hospital, Bronx, NY.
(3)ACell, Inc, Columbia, MD.
(4)Skin of All Color Dermatology and Aesthetic Medicine, LLC, East Windsor, NJ.
OBJECTIVE: To evaluate the effectiveness of a porcine urinary bladder-derived
extracellular matrix (UBM) for the treatment of recalcitrant, neuropathic
diabetic foot ulcers (DFUs).
MATERIALS AND METHODS: This prospective, parallel, randomized, single-center
study involving 17 subjects was performed in an outpatient wound care center
setting. Each subject with a DFU was randomized (2:1) to receive the urinary
bladder matrix (UBM) plus offloading with a total contact cast (TCC) or standard
care (nonadherent dressing plus TCC). All DFUs were on the plantar surface of the
foot and all were Grade I-A according to the University of Texas Wound
Classification System. A traditional TCC was used in all patients and consisted
of a minimally padded, well-molded, and rigid (plaster plus fiberglass) construct
that maintains contact with the entire plantar surface of the foot and lower leg.
The endpoints of the study were wound healing at 12 and 16 weeks and ulcer
recurrence at 1 year. Wound evaluations were performed weekly and wound surface
area was measured by photo-digital planimetry.
RESULTS: In the UBM group, the incidence of wound healing at 12 and 16 weeks was
90% and 100%, respectively, compared with 33% and 83.3% in the control (P =
.062). The mean time to healing in the UBM-treated group was 62.4 days compared
with 92.8 days in the control group (P = .031). The incidence of ulcer recurrence
at 1 year was 10% (1/11) in the UBM-treated group and 50% (3/6) in the control.
CONCLUSION: Results of this interim analysis suggest treatment of DFUs with a UBM
could significantly reduce the time to healing and improve the rate of
recurrence.
PMID: 28267677
