Food and Drug Administration (FDA) drug approval end points for chronic cutaneous ulcer studies

Wound Repair and Regeneration

Volumn 20, Issue 6, 2012, Pages 793-796

  Eaglstein, William H ^a   Kirsner, Robert S ^a   Robson, Martin C ^b  

^a UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF SOUTH FLORIDA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; ARGINYLGLYCYLASPARTIC ACID; BECAPLERMIN; EPIDERMAL GROWTH FACTOR; FIBROBLAST GROWTH FACTOR; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; HYALURONIC ACID; PLACEBO; REPIFERMIN; SOMATOMEDIN; TELBERMIN; VASCULOTROPIN;

ARTICLE; CHRONIC CUTANEOUS ULCER; CHRONIC DISEASE; DECUBITUS; DIABETIC FOOT; DRUG APPROVAL; DRUG EFFICACY; FOOD AND DRUG ADMINISTRATION; GENE THERAPY; HUMAN; MORTALITY; OVERALL SURVIVAL; PRIORITY JOURNAL; PROGNOSIS; QUALITY OF LIFE; SKIN ULCER; TREATMENT RESPONSE; ULCER; WOUND CLOSURE; WOUND HEALING;

AMPUTATION; CHRONIC DISEASE; COMORBIDITY; DEPRESSION; DRUG APPROVAL; ENDPOINT DETERMINATION; FEMALE; HUMANS; MALE; POSTOPERATIVE COMPLICATIONS; PROGNOSIS; QUALITY OF LIFE; SEPSIS; SKIN ULCER; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WOUND HEALING; WOUND INFECTION;

EID: 84868524099     PISSN: 10671927     EISSN: 1524475X     Source Type: Journal    
DOI: 10.1111/j.1524-475X.2012.00849.x     Document Type: Article

References (32)

1. 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.
2. Armstrong DG, Wrobel J, Robbins JM,. Are diabetes-related wounds and amputations worse than cancer? Int Wound J 2007; 4: 286-287.
3. Armstrong DG, Boulton AJ, Andros G, Attinger C, Eisenbud D, Lavery LA, Lipsky BA, Mills JL, Sibbald G, Smith AP, Wukich D, Margolis DJ,. Defining success in clinical trials of diabetic foot wounds: the Los Angeles DFCon consensus. Int Wound J 2009; 6: 211-213.
4. Iversen MM, Tell GS, Riise T, Hanestad BR, Ostbye T, Graue M, Midthjell K,. History of foot ulcer increases mortality among individuals with diabetes: ten-year follow-up of the Nord-TrÃndelag Health Study, Norway. Diabetes Care 2009; 32: 2193-2199.
5. Escandon J, Vivas AC, Tang J, Rowland KJ, Kirsner RS,. High mortality in patients with chronic wounds. Wound Repair Regen 2011; 19: 526-528.
6. Salcido R, Lorenzo CT,. Pressure ulcers and wound care. Medscape Reference [Internet]. Available at http://emedicine.medscape.com/article/319284 (accessed January 6, 2012).
7. Maklebust J,. Pressure ulcers: etiology and prevention. Nurs Clin North Am 1987; 22: 359-377.
8. Michocki R, Lamy P,. The problem of pressure sores in a nursing home population: statistical data. J Am Geriatr Soc 1976; 24: 323-328.
9. Maida V, Ennis M, Kuziemsky C, Corban J,. Wounds and survival in noncancer patients. J Palliat Med 2010; 13: 453-459.
10. Reed JW,. Pressure ulcers in the elderly: prevention and treatment utilizing the team approach. Md State Med J 1981; 30: 45-50.
11. Junrungsee S, Kosachunhanun N, Wongthanee A, Rerkasem K,. History of foot ulcers increases mortality among patients with diabetes in Northern Thailand. Diabet Med 2011; 28: 608-611.
12. Snyder RJ, Hanft JR,. Diabetic foot ulcers - effects on QOL, costs, and mortality and the role of standard wound care and advanced-care therapies. Ostomy Wound Manage 2009; 55: 28-38.
13. Winkley K, Sallis H, Kariyawasam D, Leelarathna LH, Chalder T, Edmonds ME, Stahl D, Ismail K,. Five-year follow-up of a cohort of people with their first diabetic foot ulcer: the persistent effect of depression on mortality. Five-year follow-up of a cohort of people with their first diabetic foot ulcer: the persistent effect of depression on mortality. Diabetologia 2012; 55: 303-310.
14. Dvorak HF,. Tumors: wounds that do not heal. N Engl J Med 1986; 315: 1650-1659.
15. Penn I, Starzl TE,. Immunosuppression and cancer. Transplant Proc 1973; 5: 943-947.
16. Engels EA, Pfeiffer RM, Fraumeni JF Jr, Kasiske BL, Israni AK, Snyder JJ, Wolfe RA, Goodrich NP, Bayakly AR, Clarke CA, Copeland G, Finch JL, Fleissner ML, Goodman MT, Kahn A, Koch L, Lynch CF, Madeleine MM, Pawlish K, Rao C, Williams MA, Castenson D, Curry M, Parsons R, Fant G, Lin M,. Spectrum of cancer risk among US solid organ transplant recipients. JAMA 2011; 306: 1891-1901.
17. Royle JA, Baade PD, Joske D, Girschik J, Fritschi L,. Second cancer incidence and cancer mortality among chronic lymphocytic leukaemia patients: a population-based study. Br J Cancer 2011; 105: 1076-1081.
18. Fearon KCH,. Cancer cachexia and fat-muscle physiology. N Engl J Med 2011; 365: 565-567.
19. Kwon P, Xing B,. Topical vascular endothelial growth factor (VEGF, telbermin) for neuropathic diabetic foot ulcers: phase II randomized, double-blind, multi-dose trial. [Internet]. Available at http://web.1.c3. audiovideoweb.com/1c3web3530/%20dfcon08abstracts/TopicalVascularEndothelial.pdf (accessed May 16, 2011).
20. Robson MC, Phillips TJ, Falanga V, Odenheimer DJ, Parish LC, Jensen JL, Steed DL,. Randomized trial of topically applied repifermin (recombinant human keratinocyte growth factor-2) to accelerate wound healing in venous ulcers. Wound Repair Regen 2001; 9: 347-352.
21. Robson MC, Phillips LG, Thomason A, Altrock BW, Pence PC, Heggers JP, Johnston AF, McHugh TP, Anthony MS, Robson LE,. Recombinant human platelet-derived growth factor-BB for the treatment of chronic pressure ulcers. Ann Plast Surg 1992; 29: 193-201.
22. Rees RS, Robson MC, Smiell JM, Perry BH,. A randomized, double blind, placebo-controlled study of Becaplermin (recombinant human platelet-derived growth factor-BB) gel in the treatment of pressure ulcers. Wound Repair Regen 1999; 7: 141-147.
23. Robson MC, Phillips LG, Lawrence WT, Bishop JB, Youngerman JS, Hayward PG, Broemeling LD, Heggers JP,. The safety and effect of topically applied recombinant basic fibroblast growth factor on the healing of chronic pressure sores. Ann Surg 1992; 216: 401-408.
24. Robson MC, Hill DP, Smith PD, Wang X, Meyer-Siegler K, Ko F, VandeBerg JS, Payne WG, Ochs D, Robson LE,. Sequential cytokine therapy for pressure ulcers: clinical and mechanistic response. Ann Surg 2000; 231: 600-611.
25. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH). Guidance for industry chronic cutaneous ulcer and burn wounds - developing products for treatment. 2006. Available at http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm071324.pdf (accessed May 16, 2011).
26. Payne WG, Ochs DE, Meltzer DD, Hill DP, Mannari RJ, Robson LE, Robson MC,. Longterm outcome study of growth factor-treated pressure ulcers. Am J Surg 2001; 181: 81-86.
27. Robson MC, Hill DP, Woodske ME, Steed DL,. Wound healing trajectories as predictors of effectiveness of therapeutic agents. Arch Surg 2000; 135: 773-777.
28. Steed DL, Hill DP, Woodske ME, Payne WG, Robson MC,. Wound healing trajectories as outcome measures of venous ulcer treatment. Int Wound J 2006; 3: 40-47.
29. Payne WG, Bhalla R, Hill DP, Pierpont YN, Robson MC,. Wound healing trajectories to determine pressure ulcer treatment. Eplasty 2011; 11: 1-8.
30. Gelfand JM, Hoffstad O, Margolis DJ,. Surrogate endpoints for the treatment of venous leg ulcers. J Invest Dermatol 2002; 119: 1420-1425.
31. Robson MC, Maggi SP, Smith PD, Wassermann RJ, Mosiello GC, Hill DP, Cooper DM,. Ease of wound closure as an endpoint of treatment efficacy. Wound Repair Regen 1999; 7: 90-96.
32. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER). Guidance for industry clinical trial endpoints for the approval of cancer drugs and biologics. 2007. Available at http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf (accessed May 16, 2011).