Diabetic foot ulcer photography study: a study within a trial to assess the reliability of two-dimensional (2D) photography for the assessment of ulcer healing in patients with diabetes-related foot ulcers-protocol paper.

ABSTRACT:

Background

The primary endpoint in diabetes-related foot ulcer (DFU) trials is often time to healing, defined as complete re-epithelialisation with absence of drainage, requiring clinical expert assessment as the gold standard. Central blinded photograph review for confirmation of healing is increasingly being undertaken for internal validity. The Diabetic Foot Ulcer Photography study aims to determine the agreement between blinded independent review panel members for assessing ulcer healing status in patients with DFUs.

Methods and analysis

Photographs of ulcers clinically assessed as healed or not healed across 300 participants recruited to one of two randomised controlled trials (MIDFUT and CODIFI2), will be independently reviewed by a central blinded panel consisting of

SUBMITTER: Brown ST 

PROVIDER: S-EPMC11752009 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature