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Open Access Study protocol

Cellular versus acellular matrix devices in treatment of diabetic foot ulcers: study protocol for a comparative efficacy randomized controlled trial

Hadar Lev-Tov12, Chin-Shang Li3, Sara Dahle12* and Roslyn Rivkah Isseroff12*

Author Affiliations

1 Veterans Affairs Medical Center, Northern California Healthcare System, 10535 Hospital Way, Mather, CA, 95655, USA

2 Department of Dermatology, University of California Davis, 3301 C Street, Sacramento, CA, 95816, USA

3 Department of Public Health Sciences, Division of Biostatistics, University of California Davis, MS1C Room 145, Davis, CA, 95616, USA

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Trials 2013, 14:8  doi:10.1186/1745-6215-14-8

Published: 9 January 2013

Abstract

Background

Diabetic foot ulcers (DFUs) represent a significant source of morbidity and an enormous financial burden. Standard care for DFUs involves systemic glucose control, ensuring adequate perfusion, debridement of nonviable tissue, off-loading, control of infection, local wound care and patient education, all administered by a multidisciplinary team. Unfortunately, even with the best standard of care (SOC) available, only 24% or 30% of DFUs will heal at weeks 12 or 20, respectively.

The extracellular matrix (ECM) in DFUs is abnormal and its impairment has been proposed as a key target for new therapeutic devices. These devices intend to replace the aberrant ECM by implanting a matrix, either devoid of cells or enhanced with fibroblasts, keratinocytes or both as well as various growth factors. These new bioengineered skin substitutes are proposed to encourage angiogenesis and in-growth of new tissue, and to utilize living cells to generate cytokines needed for wound repair.

To date, the efficacy of bioengineered ECM containing live cellular elements for improving healing above that of a SOC control group has not been compared with the efficacy of an ECM devoid of cells relative to the same SOC. Our hypothesis is that there is no difference in the improved healing effected by either of these two product types relative to SOC.

Methods/Design

To test this hypothesis we propose a randomized, single-blind, clinical trial with three arms: SOC, SOC plus Dermagraft® (bioengineered ECM containing living fibroblasts) and SOC plus Oasis® (ECM devoid of living cells) in patients with nonhealing DFUs. The primary outcome is the percentage of subjects that achieved complete wound closure by week 12.

Discussion

If our hypothesis is correct, then immense cost savings could be realized by using the orders-of-magnitude less expensive acellular ECM device without compromising patient health outcomes. The article describes the protocol proposed to test our hypothesis.

Trial registration

ClinicalTrials.gov: NCT01450943. Registered: 7 October 2011

Keywords:
Diabetic foot ulcer; Chronic wounds; Nonhealing wounds; Oasis; Dermagraft; Wound matrix