Early healing rates and wound area measurements are reliable predictors of later complete wound closure

Abstract

This study was undertaken to determine if healing rates are reliable early predictors of ultimate complete wound closure in venous leg ulcers and diabetic foot wounds. We conducted a retrospective analysis of 306 venous leg ulcers and 241 diabetic foot ulcers enrolled in two large controlled, prospective, randomized pivotal trials to compare topical wound treatments, to determine whether certain early markers of healing could be correlated with later total wound closure. Two-sided tests at 95% confidence demonstrated that wound margin advance, initial healing rate, percent wound surface area reduction, and wound healing trajectories (all p<0.001) were powerful predictors of complete wound healing at 12 weeks. Wounds with poor healing progress by these criteria at 4 weeks were highly likely to remain unhealed after 8 additional weeks of treatment. Analysis of the diabetic foot ulcers and venous leg ulcers subgroups separately demonstrated consistent statistical test results with high significance; similarly, the results remained valid independent of the topical treatment used. The early prediction of eventual wound healing or nonhealing using early healing rates may enable more efficient triage of patients to advanced healing technologies. We believe that these surrogate markers are robust predictors of healing regardless of wound etiology and that they merit wider use in clinical trials and routine patient care.

Electrostimulation: Current Status, Strength of Evidence Guidelines, and Meta-Analysis

“…[38][39][40] Expressing healing rates in PAR4 values makes it possible to compare the effects of different studies with different treatment periods. The information in the 15 RCTs was good enough allowing the authors of this review to calculate the PAR4 values from the original data.…”

Non‐contact low‐frequency ultrasound therapy compared with UK standard of care for venous leg ulcers: a single‐centre, assessor‐blinded, randomised controlled trial

“…A substantially longer trial would be required for the proportion of 100% healed wounds to be used as an outcome measure which Gottrup has argued is a better outcome measure (29). The ability of 4-week wound reduction to predict healing is well documented (30) and may have been a more appropriate factor than wound area upon which to balance the trial groups. The open-label nature of this study may also have introduced performance bias in favour of NLFU.…”

Efectividad del tratamiento de las úlceras venosas con vendaje compresivo multicapa asociado a protección de la piel perilesional con Cavilon® (película barrera no irritante)

“…Estas diferencias se mantuvieron a las 12 semanas, aunque ya no fueran estadísticamente significativas. Este dato es de gran interés ya que, por una parte y de acuerdo a trabajos previos (22,23), el porcentaje de cambio de las úlceras evaluado a las cuatro semanas de tratamiento es una medida predictiva de la evolución de las mismas, por la que se puede valorar la efectividad del tratamiento utilizado. Y, por otra parte, sugiere que la protección de la piel perilesional es clínicamente más relevante durante las primeras semanas de tratamiento, cuando los efectos del edema y la hipertensión venosa todavía se manifiestan en forma de niveles elevados de exudado en la herida, con los efectos conocidos sobre el retraso en la cicatrización.…”