title: 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.
authors.affiliation: Advanced BioHealing, New York, NY 10016, USA. mcardinal@advancedbiohealing.com
authors.forename: Matthew
authors.initials: M
authors.lastname: Cardinal
authors.forename: David E
authors.initials: DE
authors.lastname: Eisenbud
authors.forename: Tania
authors.initials: T
authors.lastname: Phillips
authors.forename: Keith
authors.initials: K
authors.lastname: Harding
mesh_terms: D001837:Body Weights and Measures; D017719:Diabetic Foot / Q000503:physiopathology*; D006801:Humans; D011237:Predictive Value of Tests; D011379:Prognosis; D012189:Retrospective Studies; D013997:Time Factors; D014647:Varicose Ulcer / Q000503:physiopathology*; D014945:Wound Healing / Q000502:physiology*; D014947:Wounds and Injuries / Q000503:physiopathology*