Frykberg RG, Marston WA, Cardinal M, et al.
Advances in skin & wound care. Date of publication 2015 Jan 1;volume 28(1):17-20.
1. Adv Skin Wound Care. 2015 Jan;28(1):17-20. doi:
10.1097/01.ASW.0000456630.12766.e9.
The incidence of lower-extremity amputation and bone resection in diabetic foot
ulcer patients treated with a human fibroblast-derived dermal substitute.
Frykberg RG(1), Marston WA, Cardinal M.
Author information:
(1)Robert G. Frykberg, DPM, MPH, is Chief of Podiatry and Residency Director,
Phoenix VA Healthcare System, Phoenix, Arizona. William A. Marston, MD, is
Medical Director, Department of Surgery, Division of Vascular Surgery, University
of North Carolina Wound Healing Center, Chapel Hill, North Carolina. Matthew
Cardinal, MS, is Clinical Research Scientist, Novartis Vaccines & Diagnostics,
Boston, Massachusetts. Dr Frykberg has disclosed that he has received research
funding from Shire Regenerative Medicine, a previous manufacturer of Dermagraft,
and previously received honoraria for lectures on diabetic foot ulcers from Shire
Regenerative Medicine. Dr Marston has disclosed that he has served as a
scientific consultant to Shire Regenerative Medicine. Mr Cardinal has disclosed
that he was an employee of Shire Regenerative Medicine at the time the manuscript
was developed. The views expressed herein are those of the authors and neither
those of the Department of Veterans Health Affairs, nor the US Government. Shire
Regenerative Medicine provided technical writing support in the development of
this manuscript. An abstract of this work was presented at the Wound Healing
Society's annual meeting April 20, 2012. Abstract citation: Frykberg RG, Marston
WA, Cardinal M. Wound Rep Reg 2012;20:A23.
OBJECTIVE: Diabetic foot ulcers (DFUs) are frequently recalcitrant and at risk
for infection, which may lead to lower-extremity amputation or bone resection.
Reporting the incidence of amputations/bone resections may shed light on the
relationship of ulcer healing to serious complications. This study aimed to
evaluate the incidence of amputations/bone resections in a randomized controlled
trial comparing human fibroblast-derived dermal substitute plus conventional care
with conventional care alone for the treatment of DFUs.
DESIGN: Ulcer-related amputation/bone resection data were extracted from data on
all adverse events reported for the intent-to-treat population (N = 314), and
amputations were categorized by type: below the knee, Syme, Chopart,
transmetatarsal, ray, toe, or partial toe. Data were analyzed retrospectively for
the incidence of amputation/bone resection by treatment.
SETTING: Randomized controlled trial.
PATIENTS: Patients with full-thickness DFUs greater than 6 weeks' duration.
INTERVENTIONS: Standard wound care plus human fibroblast-derived dermal
substitute versus standard wound care alone.
MAIN RESULTS: The incidence of amputation/bone resection in the study was 8.9%
(28/314) overall, 5.5% (9/163) for patients receiving human fibroblast-derived
dermal substitute, and 12.6% (19/151) for patients receiving conventional care (P
= .031). Of the 28 cases of amputation/bone resection, 27 were preceded by
ulcer-related infection.
CONCLUSION: There were significantly fewer amputations/bone resections in
patients who received human fibroblast-derived dermal substitute versus
conventional care, likely related to the lower incidence of infection adverse
events observed in the human fibroblast-derived dermal substitute treatment
group.
DOI: 10.1097/01.ASW.0000456630.12766.e9
PMID: 25407083 [Indexed for MEDLINE]
