Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2015 Dec 1;4(12):711-718.
doi: 10.1089/wound.2015.0645.

The Management of Diabetic Foot Ulcers with Porcine Small Intestine Submucosa Tri-Layer Matrix: A Randomized Controlled Trial

Shawn M Cazzell  1 , Darrell L Lange  2 , Jaime E Dickerson Jr  3 , Herbert B Slade  4
Affiliations

The Management of Diabetic Foot Ulcers with Porcine Small Intestine Submucosa Tri-Layer Matrix: A Randomized Controlled Trial

Shawn M Cazzell et al. Adv Wound Care (New Rochelle). .

Abstract

Objective: This study demonstrates that superior outcomes are possible when diabetic foot ulcers (DFU) are managed with tri-layer porcine small intestine submucosa (SIS). Approach: Patients with DFU from 11 centers participated in this prospective randomized controlled trial. Qualified subjects were randomized (1:1) to either SIS or standard care (SC) selected at the discretion of the Investigator and followed for 12 weeks or complete ulcer closure. Results: Eighty-two subjects (41 in each group) were evaluable in the intent-to-treat analysis. Ulcers managed with SIS had a significantly greater proportion closed by 12 weeks than for the Control group (54% vs. 32%, p=0.021) and this proportion was numerically higher at all visits. Time to closure for ulcers achieving closure was 2 weeks earlier for the SIS group than for SC. Median reduction in ulcer area was significantly greater for SIS at each weekly visit (all p values<0.05). Review of reported adverse events found no safety concerns. Innovation: These data support the use of tri-layer SIS for the effective management of DFU. Conclusion: In this randomized controlled trial, SIS was found to be associated with more rapid improvement, and a higher likelihood of achieving complete ulcer closure than those ulcers treated with SC.

PubMed Disclaimer

Figures

None
Shawn M. Cazzell, DPM
<b>Figure 1.</b>
Figure 1.
CONSORT flow diagram. SIS, tri-layer porcine small intestine submucosa. Standard care, standard care as selected by Investigator. All patients randomized were included in the intent-to-treat data set, which was used for primary inference.
<b>Figure 2.</b>
Figure 2.
Study schematic. SIS, tri-layer porcine small intestine submucosa. Standard care, standard care as selected by Investigator.
<b>Figure 3.</b>
Figure 3.
Standard care selected by the Investigator; numerals indicate number of patients treated with various standard care choices.
<b>Figure 4.</b>
Figure 4.
Proportion of closed ulcers at each visit. Tri-layer SIS, tri-layer porcine small intestine submucosa; standard care, standard care as selected by Investigator.
<b>Figure 5.</b>
Figure 5.
Median percent change in ulcer area from baseline. Tri-layer SIS, tri-layer porcine small intestine submucosa; standard care, standard care as selected by Investigator.
See this image and copyright information in PMC

References

    1. Centers for Disease Control and Prevention. National Diabetes Statistics Report: estimates of diabetes and its burden in the United States 2014. 2014. Atlanta, GA: U.S. Department of Health and Human Services; http://cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf (last accessed October19, 2014)
    1. Geiss LS, Wang J, Cheng YJ. Prevalence and incidence trends for diagnosed diabetes among adults aged 20 to 79 years, United States, 1980–2012. JAMA 2014;312:1218–1226 - PubMed
    1. Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA 2005;293:217–228 - PubMed
    1. Boulton AJM, Kirsner RS, Vileikyte L. Neuropathic diabetic foot ulcers. N Engl J Med 2004;351:48–55 - PubMed
    1. Lavery LA, Armstrong DG, Wunderlich RP, Tredwell J, Boulton AJM. Diabetic foot syndrome: evaluating the prevalence and incidence of foot pathology in Mexican Americans and non-hispanic whites from a diabetes disease management cohort. Diabetes Care 2003;26:1435–1438 - PubMed

LinkOut - more resources