The Incidence of Lower-Extremity Amputation and Bone Resection in Diabetic Foot Ulcer Patients Treated with a Human Fibroblast-Derived Dermal Substitute. (January 2015)

• Record Type: Journal Article
• Authors: Frykberg, Robert G.; Marston, William A.; Cardinal, Matthew
• Is Part Of: Advances in skin & wound care. Volume 28:Number 1(2015)
• Publication Date: 2015-01
• Subjects: Wounds and injuries -- Treatment -- Periodicals; Wound healing -- Periodicals; Skin -- Diseases -- Treatment -- Periodicals; Dermatology -- United States -- Periodicals; 617.106
• DOI: 10.1097/01.ASW.0000456630.12766.e9
• Languages: English
• ISSNs: 1527-7941

Abstract

<abstract> <title>ABSTRACT</title> <sec> <title>OBJECTIVE:</title> <p>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.</p> </sec> <sec> <title>DESIGN:</title> <p>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.</p> </sec> <sec> <title>SETTING:</title> <p>Randomized controlled trial.</p> </sec> <sec> <title>PATIENTS:</title> <p>Patients with full-thickness DFUs greater than 6 weeks' duration.</p> </sec> <sec> <title>INTERVENTIONS:</title> <p>Standard wound care plus human fibroblast-derived dermal substitute versus standard wound care alone.</p> </sec> <sec> <title>MAIN RESULTS:</title> <p>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 (<italic>P</italic> = .031). Of the 28 cases of amputation/bone resection, 27 were preceded by ulcer-related infection.</p> </sec> <sec> <title>CONCLUSION:</title> <p>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.</p> </sec> </abstract>