A novel metric in chronic wound healing research

A novel metric in chronic wound healing research

High-quality evidence to guide treatment selection of chronic wound healing remains lacking. The conventional parallel-arm randomized controlled trial (RCT) model for wound healing studies has limitations. Complete wound closure as a primary endpoint necessitates trials with large sample sizes and prolonged follow-up to achieve adequate statistical power. Such trials are logistically difficult to conduct and may fail to detect more modest treatment effects on wound healing kinetics.

The Food and Drug Administration (FDA) now recognizes PAR as a potential primary endpoint for registrational wound healing trials. PAR following a linear trajectory over time, allows more granular detection of changes in a wound healing rate. A PAR self-controlled study model leverages within-patient comparisons, thereby removing potential confounding from between-patient differences.

Our recent two-phase study of 60 patients with VLUs provides a salient example of this trial design. There was an initial 4-week run-in phase with standard compression therapy alone. Patients were then randomized to continue compression alone or add adjunctive neuromuscular electrical stimulation (the geko™ device) for an additional 4 weeks. The addition of the geko device significantly increased the PAR rate compared to compression alone in the same patient cohort (p=0.016). Meanwhile, the control group’s healing rate was unchanged between study phases.

These findings demonstrate the feasibility of employing PAR and within-patient controls to efficiently discriminate treatment effects with a limited sample size over a 2-month study duration.

The design of wound healing trials has been constrained by over-reliance on complete wound closure in large cohorts. New metrics, like PAR, provide higher-quality evidence to improve wound care.

To read the full article in Wound Masterclass click here.

To view to our Head of Clinical Studies Dr Kieron Day, present a novel study metric – Percentage Area Reduction (PAR) click here.

To read our recently published study click here.

 

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