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

Trials

Volumn 14, Issue 1, 2013, Pages

  Lev Tov, Hadar ^a,b   Li, Chin Shang ^b   Dahle, Sara ^a,b   Isseroff, Roslyn Rivkah ^a,b  

^a VETERANS AFFAIRS MEDICAL CENTER   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

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

Indexed keywords

ACELLULAR DERMAL MATRIX; ADULT; AGED; ANGIOGENESIS; ARTICLE; CLINICAL EFFECTIVENESS; CLINICAL PROTOCOL; COMPARATIVE STUDY; CONTROLLED STUDY; COST CONTROL; COST EFFECTIVENESS ANALYSIS; DIABETIC FOOT; EXTRACELLULAR MATRIX; FOLLOW UP; HUMAN; HUMAN CELL; KERATINOCYTE; MAJOR CLINICAL STUDY; OUTCOME ASSESSMENT; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; SKIN FIBROBLAST; TISSUE ENGINEERING; WOUND CLOSURE; WOUND DRESSING;

BIOENGINEERING; CLINICAL PROTOCOLS; DIABETIC FOOT; EXTRACELLULAR MATRIX; FIBROBLASTS; HUMANS; RESEARCH DESIGN; SAMPLE SIZE; SINGLE-BLIND METHOD;

EID: 84872042486     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-14-8     Document Type: Article

References (29)

1. Center for Disease Control and Prevention National Diabetes Fact Sheet: National Estimates and General Information on Diabetes and Prediabetes in the United States, 2011 2011, Atlanta, GA: Department of Health and Human Services, Center for Disease Control and Prevention.
2. Margolis DJ, Hoffstad O, Nafash J, Leonard CE, Freeman CP, Hennessy S, Wiebe DJ. Location, location, location: geographic clustering of lower-extremity amputation among Medicare beneficiaries with diabetes. Diabetes Care 2011, 34:2363-2367. 10.2337/dc11-0807, 3198303, 21933906.
3. Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, Apelqvist J. The global burden of diabetic foot disease. Lancet 2005, 366:1719-1724. 10.1016/S0140-6736(05)67698-2, 16291066.
4. Sen CK, Gordillo GM, Roy S, Kirsner R, Lambert L, Hunt TK, Gottrup F, Gurtner GC, Longaker MT. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen 2009, 17:763-771. 10.1111/j.1524-475X.2009.00543.x, 2810192, 19903300.
5. Apelqvist J, Bakker K, van Houtum WH, Schaper NC. Practical guidelines on the management and prevention of the diabetic foot: based upon the International Consensus on the Diabetic Foot (2007) Prepared by the International Working Group on the Diabetic Foot. Diabetes Metab Res Rev 2008, 24(Suppl 1):S181-S187.
6. Falanga V. Wound healing and its impairment in the diabetic foot. Lancet 2005, 366:1736-1743. 10.1016/S0140-6736(05)67700-8, 16291068.
7. Brem H, Sheehan P, Boulton AJ. Protocol for treatment of diabetic foot ulcers. Am J Surg 2004, 187:1S-10S. 10.1016/S0002-9610(03)00299-X, 15147985.
8. Game FL, Hinchliffe RJ, Apelqvist J, Armstrong DG, Bakker K, Hartemann A, Löndahl M, Price PE, Jeffcoate WJ, . International Working Group on Diabetic Foot Specific guidelines on wound and wound-bed management 2011. Diabetes Metab Res Rev 2012, 28(Suppl 1):232-233. International Working Group on Diabetic Foot.
9. Bakker K, Apelqvist J, Schaper NC. Practical guidelines on the management and prevention of the diabetic foot 2011. Diabetes Metab Res Rev 2012, 28(Suppl 1):225-231.
10. Lepantalo M, Apelqvist J, Setacci C, Ricco JB, de Donato G, Becker F, Robert-Ebadi H, Cao P, Eckstein HH, De Rango P, Diehm N, Schmidli J, Teraa M, Moll FL, Dick F, Davies AH. Chapter V: Diabetic foot. Eur J Vasc Endovasc Surg 2011, 42(Suppl 2):S60-S74.
11. Margolis DJ, Kantor J, Berlin JA. Healing of diabetic neuropathic foot ulcers receiving standard treatment. A meta-analysis. Diabetes Care 1999, 22:692-695. 10.2337/diacare.22.5.692, 10332667.
12. Singer AJ, Clark RA. Cutaneous wound healing. N Engl J Med 1999, 341:738-746. 10.1056/NEJM199909023411006, 10471461.
13. Gary Sibbald R, Woo KY. The biology of chronic foot ulcers in persons with diabetes. Diabetes Metab Res Rev 2008, 24(Suppl 1):S25-S30.
14. Loots MA, Lamme EN, Zeegelaar J, Mekkes JR, Bos JD, Middelkoop E. Differences in cellular infiltrate and extracellular matrix of chronic diabetic and venous ulcers versus acute wounds. J Invest Dermatol 1998, 111:850-857. 10.1046/j.1523-1747.1998.00381.x, 9804349.
15. Medina A, Scott PG, Ghahary A, Tredget EE. Pathophysiology of chronic nonhealing wounds. J Burn Care Rehabil 2005, 26:306-319. 10.1097/01.BCR.0000169887.04973.3A, 16006837.
16. Mendoza-Naranjo A, Cormie P, Serrano AE, Wang CM, Thrasivoulou C, Sutcliffe JE, Gilmartin DJ, Tsui J, Serena TE, Phillips AR, Becker DL. Overexpression of the gap junction protein Cx43 as found in diabetic foot ulcers can retard fibroblast migration. Cell Biol Int 2012, 36:661-667. 10.1042/CBI20110628, 22455314.
17. Neut D, Tijdens-Creusen EJ, Bulstra SK, van der Mei HC, Busscher HJ. Biofilms in chronic diabetic foot ulcers - a study of 2 cases. Acta Orthop 2011, 82:383-385. 10.3109/17453674.2011.581265, 3235322, 21561305.
18. Bajpai S, Shukla VK, Tripathi K, Srikrishna S, Singh RK. Targeting connexin 43 in diabetic wound healing: future perspectives. J Postgrad Med 2009, 55:143-149. 10.4103/0022-3859.48786, 19550065.
19. Panuncialman J, Falanga V. The science of wound bed preparation. Surg Clin North Am 2009, 89:611-626. 10.1016/j.suc.2009.03.009, 19465200.
20. Gentzkow GD, Iwasaki SD, Hershon KS, Mengel M, Prendergast JJ, Ricotta JJ, Steed DP, Lipkin S. Use of dermagraft, a cultured human dermis, to treat diabetic foot ulcers. Diabetes Care 1996, 19:350-354. 10.2337/diacare.19.4.350, 8729158.
21. Niezgoda JA, Van Gils CC, Frykberg RG, Hodde JP. Randomized clinical trial comparing OASIS Wound Matrix to Regranex Gel for diabetic ulcers. Adv Skin Wound Care 2005, 18(5 Pt 1):258-266.
22. For Non-healing Diabetic Foot Ulcers. , http://www.dermagraft.com/about/overview
23. Healthpoint Offers Two Oasis® Matrix Products. , http://www.oasiswoundmatrix.com/
24. Wu SC, Jensen JL, Weber AK, Robinson DE, Armstrong DG. Use of pressure offloading devices in diabetic foot ulcers: do we practice what we preach?. Diabetes Care 2008, 31:2118-2119. 10.2337/dc08-0771, 2571059, 18694976.
25. Ranjita Misra LL, David V, Ashley M, Khanna SR, Sen CK. Predictors of Diabetic Wound Healing by Racial/Ethnic Categories [poster] 2012, Columbus OH: The Ohio State University Comprehensive Wound Center., http://misra.tamu.edu/chronic_healing.html
26. Goodson WH, Goodson WH, Hunt TK. Wound healing and aging. J Invest Dermatol 1979, 73:88-91. 10.1111/1523-1747.ep12532775, 448182.
27. Elliott AC, Hynan LS. A SAS® macro implementation of a multiple comparison post hoc test for a Kruskal-Wallis analysis. Comput Methods Programs Biomed 2011, 102:75-80. 10.1016/j.cmpb.2010.11.002, 21146248.
28. Statistical Analysis System. , http://www.sas.com
29. Lundh A, Krogsboll LT, Gotzsche PC. Sponsors' participation in conduct and reporting of industry trials: a descriptive study. Trials 2012, 13:146. 10.1186/1745-6215-13-146, 3502592, 22920226.