Marston WA, Ennis WJ, Lantis JC 2nd, Kirsner RS, Galiano RD, Vanscheidt W, Eming SA, Malka M, Cargill DI, Dickerson JE Jr, Slade HB, HP802-247 Study Group., et al.
Journal of vascular surgery. Venous and lymphatic disorders. Date of publication 2017 Nov 1;volume 5(6):829-835.e1.
1. J Vasc Surg Venous Lymphat Disord. 2017 Nov;5(6):829-835.e1. doi:
10.1016/j.jvsv.2017.06.017.
Baseline factors affecting closure of venous leg ulcers.
Marston WA(1), Ennis WJ(2), Lantis JC 2nd(3), Kirsner RS(4), Galiano RD(5),
Vanscheidt W(6), Eming SA(7), Malka M(8), Cargill DI(9), Dickerson JE Jr(10),
Slade HB(11); HP802-247 Study Group.
Collaborators: Andersen CA, Anderson CA, Arenberger P, Aschoff R, Augustin M,
Bakos N, Beele H, Bervoets A, Cavorsi J, Cazzell SM, Cetkovska P, Clements JR,
Cook EA, Deck KB, De Conninck A, Despatis MA, Dhillon YS, Dissemond J, Dove C,
Emmert S, Eming S, Ennis WJ, Enriquez GL, Farber A, Filipovska O, Frykberg RG,
Gagnon JJ, Galiano R, George T, Giacalone V, Gordon IL, Grzela T, Hajdu C, Hanft
JR, Homey B, Hood DB, Horn T, Jimenez JC, Juenger M, Keast DH, Kemeny L, Kim PJ,
Kirsner RS, Kotala M, Lantis JC 2nd, Lauf L, Lavery L, Lawall H, Lawrence PF,
Malka M, Marston WA, Matejkova A, Mayer PV, Mikosinski J, Molyneaux MM, Moore MF,
Mostow EN, Motley TA, Nemes E, Pavlasova V, Quist S, Remenyik E, Reyzelman AM,
Rez R, Rock PB, Ruzicka T, Rybak Z, Shebetka KA, Shimozaki KK, Simka M, Stuecker
M, Stuchlik D, Swiercz P, Tassone J Jr, Twardowska-Saucha K, Van Gils C,
Vanscheidt W, Varkonyi I, Vartivarian M, Vasku V, Vayser D, Walters J,
Weichenthal M, Wu SCS, Zenilman JM, Zimolova R, Zubilewicz T.
Author information:
(1)Division of Vascular Surgery, University of North Carolina School of Medicine,
Chapel Hill, NC. Electronic address: william_marston@med.unc.edu.
(2)Division of Vascular Surgery, Section of Wound Healing and Tissue Repair,
University of Illinois Hospital and Health Sciences System, Chicago, Ill.
(3)Division of Vascular and Endovascular Surgery, Mt. Sinai West and St. Luke's
Hospitals, New York, NY.
(4)Department of Dermatology and Cutaneous Surgery, Miller School of Medicine,
University of Miami, Miami, Fla.
(5)Division of Plastic Surgery, Northwestern University Feinberg School of
Medicine, Chicago, Ill.
(6)University of Freiburg, Freiburg, Germany.
(7)Department of Dermatology, University of Cologne, Cologne, Germany.
(8)Przychodnia Lekarsko-Podologiczno Rehabilitacyjna PODOS, Warsaw, Poland.
(9)Smith & Nephew, Inc, Fort Worth, Tex.
(10)Smith & Nephew, Inc, Fort Worth, Tex; Graduate School of Biomedical Sciences,
University of North Texas Health Science Center, Fort Worth, Tex.
(11)Smith & Nephew, Inc, Fort Worth, Tex; Department of Pediatrics, University of
North Texas Health Science Center, Fort Worth, Tex.
Comment in
J Vasc Surg Venous Lymphat Disord. 2017 Nov;5(6):836.
OBJECTIVE: The objective of this study was to characterize factors associated
with closure of venous leg ulcers (VLUs) in a pooled analysis of subjects from
three randomized clinical trials.
METHODS: Closure of VLUs after treatment with HP802-247, an allogeneic living
cell therapy consisting of growth-arrested human keratinocytes and fibroblasts,
vs standard therapy with compression bandaging was evaluated in three phase 3
clinical trials of similar design. Two trials enrolled subjects with VLUs ranging
from 2 cm2 to 12 cm2 in area with 12-week treatment periods; the third trial
enrolled subjects with VLUs between >12 cm2 and ≤36 cm2 with a 16-week treatment
period. The first trial went to completion but failed to demonstrate a benefit to
therapy with HP802-247 compared with placebo, and because of this, the remaining
trials were terminated before completion. On the basis of no differences in
outcomes between groups, subjects from both HP802-247 and control groups were
pooled across all three studies. Cox proportional hazards regression analysis was
employed to evaluate factors associated with VLU closure.
RESULTS: This analysis included data from 716 subjects with VLU. Factors
evaluated for association with healing included age, gender, race, diabetes,
glycated hemoglobin level, body mass index, treatment (HP802-247 vs compression
alone), and ulcer characteristics including location and area and duration at
baseline. In an initial model including all of these putative factors, the
following were significant at the P < .10 level: diagnosis of diabetes mellitus,
gender, wound location (ankle or leg), baseline wound area, and wound duration at
baseline. In a final model including only these factors, all but diabetes
mellitus were significant at the P < .05 level. Effect sizes were as follows
(hazard ratio [95% confidence interval]): female gender (1.384 [1.134-1.690]),
wound location on the leg (1.490 [1.187-1.871]), smaller wound area at baseline
(0.907 [0.887-0.927]), and shorter wound duration at baseline (0.971
[0.955-0.987]).
CONCLUSIONS: Factors associated with VLU lesions including location, area, and
duration were important predictors of healing. Women were more likely than men to
achieve wound closure. Factors including body mass index, the presence of
diabetes mellitus, and higher concentrations of glycated hemoglobin were not
significant independent predictors of wound closure in this analysis.
Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All
rights reserved.
DOI: 10.1016/j.jvsv.2017.06.017
PMID: 29037354 [Indexed for MEDLINE]
