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Peer-reviewedCC BYVascular Health and Risk Management

Association Between Wound Exudate Severity and Time to Healing Among Patients with Venous Leg Ulcers (VLUs): A Real-World Retrospective Cohort Study

6 affiliations
  1. 1Division of Vascular and Endovascular Surgery
  2. 2HEOR
  3. 3Evidence Generation Department
  4. 4Evidence Generation
  5. 5Keck School of Medicine
  6. 6Department of Epidemiology

Abstract

Peter Gloviczki,1 Yun Han,2 Vladica Velickovic,3,4 Grace Gahlon,2 Cornelia Santoso,3 Shelby L Corman,2 David G Armstrong,5 Jan Kottner,6 Kenneth J Rothman7 1Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN, USA; 2Precision AQ, Bethesda, MD, USA; 3Evidence Generation Department, HARTMANN GROUP, Heidenheim, Germany; 4Institute of Public Health, Medical Decision Making and Health Technology Assessment, UMIT, Hall in Tirol, Austria; 5Keck School of Medicine of University of Southern California, Los Angeles, CA, USA; 6Institute for Clinical Nursing Science, Charité-Universitätsmedizin, Berlin, Germany; 7Department of Epidemiology, Boston University School of Public Health, Boston, MA, USACorrespondence: Vladica Velickovic, Email [email protected]: To evaluate the relationship between wound exudate severity and time to healing among venous leg ulcers (VLUs).Design: A retrospective cohort study was conducted using Net Health WoundExpert electronic health record data from United States outpatient wound care centers 2002– 2020. The status of VLUs was followed from the initial wound clinic visit until healing or censoring.Methods: Exudate severity (none, mild, moderate, or heavy) was modeled as a time-varying exposure, and the outcome was time to complete healing. Weighted Royston–Parmar flexible parametric survival models were used to fit marginal structural models. Stabilized inverse probability of treatment and censoring weights were applied to address time varying confounding and informative censoring. The weight models included demographic characteristics, clinical factors, and wound specific variables. Effect measures included average hazard ratios, healing probabilities, and restricted mean survival time (RMST).Results: The cohort included 8,184 patients (mean age 67.8 years; 48.1% male) contributing 18,435 VLUs. Increasing exudate severity was associated with progressively lower rates of healing, with adjusted hazard ratio for mild (HR 0.24; 95% CI 0.20– 0.29), moderate (HR 0.20; 95% CI 0.16– 0.25), and heavy exudate (HR 0.15; 95% CI 0.10– 0.22), compared with ulcers without exudate. Interval-specific average hazard ratios showed similar patterns. At 12 weeks, higher exudate levels were associated with substantially lower healing probabilities (46.1%, 29.4%, and 18.4% for mild, moderate, and heavy exudate vs 92.7% with no exudate) and longer time unhealed (62.8, 70.4, and 75.3 days vs 31.4 days).Conclusion: Higher wound exudate severity was associated with markedly delayed healing among VLUs in routine outpatient care. Because “no exudate” is not a typical clinical state for an active VLU, these estimates are best interpreted as relative prognostic contrasts along the exudate gradient rather than as expected trajectories for a hypothetical exudate-free VLU. Routine exudate assessment may provide useful prognostic information regarding healing trajectories among patients with VLUs.Plain Language Summary: This study shows that clinically assessed wound exudate severity is associated with healing as a time-dependent prognostic factor of VLU in routine outpatient care. In a large longitudinal electronic health record cohort, higher exudate burden was associated with lower hazards of healing, reduced cumulative healing probabilities, and longer time to healing. Using marginal structural models and flexible parametric survival analysis, this study provides population-level estimates of relative and absolute healing outcomes. These findings extend existing evidence by quantifying the magnitude and persistence of delayed healing associated with exudate severity, supporting its relevance for prognostic assessment and monitoring in VLU management.Keywords: varicose ulcer, wound exudates, wound healing, electronic health records, survival analysis

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BibTeX
@article{gloviczki2026association,
  title = {{Association Between Wound Exudate Severity and Time to Healing Among Patients with Venous Leg Ulcers (VLUs): A Real-World Retrospective Cohort Study}},
  author = {Gloviczki P and Han Y and Velickovic V and Gahlon G and Santoso C and Corman SL and Armstrong DG and Kottner J and Rothman KJ},
  journal = {Vascular Health and Risk Management},
  year = {2026},
  month = nov,
  url = {https://www.dovepress.com/association-between-wound-exudate-severity-and-time-to-healing-among-p-peer-reviewed-fulltext-article-VHRM},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Association Between Wound Exudate Severity and Time to Healing Among Patients with Venous Leg Ulcers (VLUs): A Real-World Retrospective Cohort Study
AU  - Gloviczki P
AU  - Han Y
AU  - Velickovic V
AU  - Gahlon G
AU  - Santoso C
AU  - Corman SL
AU  - Armstrong DG
AU  - Kottner J
AU  - Rothman KJ
PY  - 2026
DA  - 2026/11/08
JO  - Vascular Health and Risk Management
UR  - https://www.dovepress.com/association-between-wound-exudate-severity-and-time-to-healing-among-p-peer-reviewed-fulltext-article-VHRM
AB  - Peter Gloviczki,1 Yun Han,2 Vladica Velickovic,3,4 Grace Gahlon,2 Cornelia Santoso,3 Shelby L Corman,2 David G Armstrong,5 Jan Kottner,6 Kenneth J Rothman7 1Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN, USA; 2Precision AQ, Bethesda, MD, USA; 3Evidence Generation Department, HARTMANN GROUP, Heidenheim, Germany; 4Institute of Public Health, Medical Decision Making and Health Technology Assessment, UMIT, Hall in Tirol, Austria; 5Keck School of Medicine of University of Southern California, Los Angeles, CA, USA; 6Institute for Clinical Nursing Science, Charité-Universitätsmedizin, Berlin, Germany; 7Department of Epidemiology, Boston University School of Public Health, Boston, MA, USACorrespondence: Vladica Velickovic, Email [email protected]: To evaluate the relationship between wound exudate severity and time to healing among venous leg ulcers (VLUs).Design: A retrospective cohort study was conducted using Net Health WoundExpert electronic health record data from United States outpatient wound care centers 2002– 2020. The status of VLUs was followed from the initial wound clinic visit until healing or censoring.Methods: Exudate severity (none, mild, moderate, or heavy) was modeled as a time-varying exposure, and the outcome was time to complete healing. Weighted Royston–Parmar flexible parametric survival models were used to fit marginal structural models. Stabilized inverse probability of treatment and censoring weights were applied to address time varying confounding and informative censoring. The weight models included demographic characteristics, clinical factors, and wound specific variables. Effect measures included average hazard ratios, healing probabilities, and restricted mean survival time (RMST).Results: The cohort included 8,184 patients (mean age 67.8 years; 48.1% male) contributing 18,435 VLUs. Increasing exudate severity was associated with progressively lower rates of healing, with adjusted hazard ratio for mild (HR 0.24; 95% CI 0.20– 0.29), moderate (HR 0.20; 95% CI 0.16– 0.25), and heavy exudate (HR 0.15; 95% CI 0.10– 0.22), compared with ulcers without exudate. Interval-specific average hazard ratios showed similar patterns. At 12 weeks, higher exudate levels were associated with substantially lower healing probabilities (46.1%, 29.4%, and 18.4% for mild, moderate, and heavy exudate vs 92.7% with no exudate) and longer time unhealed (62.8, 70.4, and 75.3 days vs 31.4 days).Conclusion: Higher wound exudate severity was associated with markedly delayed healing among VLUs in routine outpatient care. Because “no exudate” is not a typical clinical state for an active VLU, these estimates are best interpreted as relative prognostic contrasts along the exudate gradient rather than as expected trajectories for a hypothetical exudate-free VLU. Routine exudate assessment may provide useful prognostic information regarding healing trajectories among patients with VLUs.Plain Language Summary: This study shows that clinically assessed wound exudate severity is associated with healing as a time-dependent prognostic factor of VLU in routine outpatient care. In a large longitudinal electronic health record cohort, higher exudate burden was associated with lower hazards of healing, reduced cumulative healing probabilities, and longer time to healing. Using marginal structural models and flexible parametric survival analysis, this study provides population-level estimates of relative and absolute healing outcomes. These findings extend existing evidence by quantifying the magnitude and persistence of delayed healing associated with exudate severity, supporting its relevance for prognostic assessment and monitoring in VLU management.Keywords: varicose ulcer, wound exudates, wound healing, electronic health records, survival analysis
SN  - 1178-2048
SN  - 1176-6344
ER  -