Clinical benchmark for healing of chronic venous ulcers

Ross T. Lyon; Frank J. Veith; Laura Bolton; Fidelis Machado; Donald Belsito; John Blebea; Lloyd Cleaver; Anthony Comerota; G. Richard Curl; Herbert Dardik; James Dennis; Bo Eklof; Vincent Falanga; Louis Falo; Duyen Faira; Jay Fisher; Thomas Garland; David Gilepsie; Mitchel Goldman; Adelaide Herbert; Jamal Hoballah; John Hugill; William Krupski; Benjamin Levy; Joann Lohr; Mark Meissner; James O. Monzoian; William Mullcian; Jeffrey Olin; Tania Phillips; John Porter; John J. Ricotta; Robert Scheinfeld; Anton Sidawy; Ronald Snyder; Stephen Storfer; Jonathon Towne; Robert Weiss; Thomas Whitsett

doi:10.1016/S0002-9610(98)00136-6

Clinical benchmark for healing of chronic venous ulcers

Ross T. Lyon, Frank J. Veith, Laura Bolton, Fidelis Machado, Donald Belsito, John Blebea, Lloyd Cleaver, Anthony Comerota, G. Richard Curl, Herbert Dardik, James Dennis, Bo Eklof, Vincent Falanga, Louis Falo, Duyen Faira, Jay Fisher, Thomas Garland, David Gilepsie, Mitchel Goldman, Adelaide HerbertJamal Hoballah, John Hugill, William Krupski, Benjamin Levy, Joann Lohr, Mark Meissner, James O. Monzoian, William Mullcian, Jeffrey Olin, Tania Phillips, John Porter, John J. Ricotta, Robert Scheinfeld, Anton Sidawy, Ronald Snyder, Stephen Storfer, Jonathon Towne, Robert Weiss, Thomas Whitsett

CMU Medical Education Partners

Research output: Contribution to journal › Article › peer-review

42 Scopus citations

Abstract

BACKGROUND: To determine the results of standardized ulcer treatment regimes and effects of the oral thromboxane A₂ antagonist Ifetroban (250 mg daily) on healing of chronic lower-extremity venous stasis ulcers. METHODS: In a prospective, randomized, double blind, placebo-controlled multicenter study, 165 patients were randomized to Ifetroban (n = 83) versus placebo (n = 82) for a period of 12 weeks. Both groups were treated with sustained graduated compression and hydrocolloid. Ulcer size was measured weekly by tracings and computerized planimetry. A total of 150 patients completed the study. RESULTS: Complete ulcer healing was achieved after 12 weeks in 55% of patients receiving Ifetroban and in 54% of those taking a placebo with no significant differences; 84% of ulcers in both groups achieved greater than 50% area reduction in size. CONCLUSIONS: These results are likely to be useful as a benchmark for comparison with other treatment protocols concerning the care of chronic lower-extremity stasis ulcers.

Original language	English
Pages (from-to)	172-175
Number of pages	4
Journal	American Journal of Surgery
Volume	176
Issue number	2
DOIs	https://doi.org/10.1016/S0002-9610(98)00136-6
State	Published - Aug 1998

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Lyon, R. T., Veith, F. J., Bolton, L., Machado, F., Belsito, D., Blebea, J., Cleaver, L., Comerota, A., Curl, G. R., Dardik, H., Dennis, J., Eklof, B., Falanga, V., Falo, L., Faira, D., Fisher, J., Garland, T., Gilepsie, D., Goldman, M., ... Whitsett, T. (1998). Clinical benchmark for healing of chronic venous ulcers. American Journal of Surgery, 176(2), 172-175. https://doi.org/10.1016/S0002-9610(98)00136-6

@article{0bf0e06719e04fc08eef6f705c150cf1,

title = "Clinical benchmark for healing of chronic venous ulcers",

abstract = "BACKGROUND: To determine the results of standardized ulcer treatment regimes and effects of the oral thromboxane A2 antagonist Ifetroban (250 mg daily) on healing of chronic lower-extremity venous stasis ulcers. METHODS: In a prospective, randomized, double blind, placebo-controlled multicenter study, 165 patients were randomized to Ifetroban (n = 83) versus placebo (n = 82) for a period of 12 weeks. Both groups were treated with sustained graduated compression and hydrocolloid. Ulcer size was measured weekly by tracings and computerized planimetry. A total of 150 patients completed the study. RESULTS: Complete ulcer healing was achieved after 12 weeks in 55% of patients receiving Ifetroban and in 54% of those taking a placebo with no significant differences; 84% of ulcers in both groups achieved greater than 50% area reduction in size. CONCLUSIONS: These results are likely to be useful as a benchmark for comparison with other treatment protocols concerning the care of chronic lower-extremity stasis ulcers.",

author = "Lyon, {Ross T.} and Veith, {Frank J.} and Laura Bolton and Fidelis Machado and Donald Belsito and John Blebea and Lloyd Cleaver and Anthony Comerota and Curl, {G. Richard} and Herbert Dardik and James Dennis and Bo Eklof and Vincent Falanga and Louis Falo and Duyen Faira and Jay Fisher and Thomas Garland and David Gilepsie and Mitchel Goldman and Adelaide Herbert and Jamal Hoballah and John Hugill and William Krupski and Benjamin Levy and Joann Lohr and Mark Meissner and Monzoian, {James O.} and William Mullcian and Jeffrey Olin and Tania Phillips and John Porter and Ricotta, {John J.} and Robert Scheinfeld and Anton Sidawy and Ronald Snyder and Stephen Storfer and Jonathon Towne and Robert Weiss and Thomas Whitsett",

note = "Funding Information: Therefore, to assess the possible benefits of a uniform ulcer-care protocol and the use of Ifetroban in the healing of chronic lower-extremity venous stasis ulcers, a standardized outpatient ulcer treatment regimen was established and used prospectively in patients randomized to receive either the active oral agent or a placebo. This double-blinded study was funded by Bristol-Myers, Squibb, and ConVatec Corporations. ",

year = "1998",

month = aug,

doi = "10.1016/S0002-9610(98)00136-6",

language = "English",

volume = "176",

pages = "172--175",

journal = "American Journal of Surgery",

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Lyon, RT, Veith, FJ, Bolton, L, Machado, F, Belsito, D, Blebea, J, Cleaver, L, Comerota, A, Curl, GR, Dardik, H, Dennis, J, Eklof, B, Falanga, V, Falo, L, Faira, D, Fisher, J, Garland, T, Gilepsie, D, Goldman, M, Herbert, A, Hoballah, J, Hugill, J, Krupski, W, Levy, B, Lohr, J, Meissner, M, Monzoian, JO, Mullcian, W, Olin, J, Phillips, T, Porter, J, Ricotta, JJ, Scheinfeld, R, Sidawy, A, Snyder, R, Storfer, S, Towne, J, Weiss, R & Whitsett, T 1998, 'Clinical benchmark for healing of chronic venous ulcers', American Journal of Surgery, vol. 176, no. 2, pp. 172-175. https://doi.org/10.1016/S0002-9610(98)00136-6

TY - JOUR

T1 - Clinical benchmark for healing of chronic venous ulcers

AU - Lyon, Ross T.

AU - Veith, Frank J.

AU - Bolton, Laura

AU - Machado, Fidelis

AU - Belsito, Donald

AU - Blebea, John

AU - Cleaver, Lloyd

AU - Comerota, Anthony

AU - Curl, G. Richard

AU - Dardik, Herbert

AU - Dennis, James

AU - Eklof, Bo

AU - Falanga, Vincent

AU - Falo, Louis

AU - Faira, Duyen

AU - Fisher, Jay

AU - Garland, Thomas

AU - Gilepsie, David

AU - Goldman, Mitchel

AU - Herbert, Adelaide

AU - Hoballah, Jamal

AU - Hugill, John

AU - Krupski, William

AU - Levy, Benjamin

AU - Lohr, Joann

AU - Meissner, Mark

AU - Monzoian, James O.

AU - Mullcian, William

AU - Olin, Jeffrey

AU - Phillips, Tania

AU - Porter, John

AU - Ricotta, John J.

AU - Scheinfeld, Robert

AU - Sidawy, Anton

AU - Snyder, Ronald

AU - Storfer, Stephen

AU - Towne, Jonathon

AU - Weiss, Robert

AU - Whitsett, Thomas

N1 - Funding Information: Therefore, to assess the possible benefits of a uniform ulcer-care protocol and the use of Ifetroban in the healing of chronic lower-extremity venous stasis ulcers, a standardized outpatient ulcer treatment regimen was established and used prospectively in patients randomized to receive either the active oral agent or a placebo. This double-blinded study was funded by Bristol-Myers, Squibb, and ConVatec Corporations.

PY - 1998/8

Y1 - 1998/8

N2 - BACKGROUND: To determine the results of standardized ulcer treatment regimes and effects of the oral thromboxane A2 antagonist Ifetroban (250 mg daily) on healing of chronic lower-extremity venous stasis ulcers. METHODS: In a prospective, randomized, double blind, placebo-controlled multicenter study, 165 patients were randomized to Ifetroban (n = 83) versus placebo (n = 82) for a period of 12 weeks. Both groups were treated with sustained graduated compression and hydrocolloid. Ulcer size was measured weekly by tracings and computerized planimetry. A total of 150 patients completed the study. RESULTS: Complete ulcer healing was achieved after 12 weeks in 55% of patients receiving Ifetroban and in 54% of those taking a placebo with no significant differences; 84% of ulcers in both groups achieved greater than 50% area reduction in size. CONCLUSIONS: These results are likely to be useful as a benchmark for comparison with other treatment protocols concerning the care of chronic lower-extremity stasis ulcers.

AB - BACKGROUND: To determine the results of standardized ulcer treatment regimes and effects of the oral thromboxane A2 antagonist Ifetroban (250 mg daily) on healing of chronic lower-extremity venous stasis ulcers. METHODS: In a prospective, randomized, double blind, placebo-controlled multicenter study, 165 patients were randomized to Ifetroban (n = 83) versus placebo (n = 82) for a period of 12 weeks. Both groups were treated with sustained graduated compression and hydrocolloid. Ulcer size was measured weekly by tracings and computerized planimetry. A total of 150 patients completed the study. RESULTS: Complete ulcer healing was achieved after 12 weeks in 55% of patients receiving Ifetroban and in 54% of those taking a placebo with no significant differences; 84% of ulcers in both groups achieved greater than 50% area reduction in size. CONCLUSIONS: These results are likely to be useful as a benchmark for comparison with other treatment protocols concerning the care of chronic lower-extremity stasis ulcers.

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U2 - 10.1016/S0002-9610(98)00136-6

DO - 10.1016/S0002-9610(98)00136-6

M3 - Article

C2 - 9737626

AN - SCOPUS:0032143393

VL - 176

SP - 172

EP - 175

JO - American Journal of Surgery

JF - American Journal of Surgery

SN - 0002-9610

IS - 2

ER -

Clinical benchmark for healing of chronic venous ulcers

Abstract

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