The Prognostic Value of Transcutaneous Oxygen Pressure (TcPO2) in Diabetic Foot Ulcer Healing: A Protocol for a Systematic Review

Abstract

Background/Objectives: Due to poor perfusion, diabetic foot ulcers (DFUs) create hypoxic environments, and their chronicity represents a negative factor in wound healing. Transcutaneous oxygen pressure (TcPO₂) is a non-invasive method that provides information on oxygen supply to microvascular circulation, useful for determining the severity and progression of peripheral arterial disease (PAD) as well as potentially predicting DFU healing. However, the current literature does not provide strong support for the use of TcPO₂ as an independent predictive tool. Methods: This protocol aims to systematically review the available evidence according to PRISMA (2020) guidelines, registered with the International Prospective Register of Systematic Reviews (registration number: CRD42024505907). The following databases will be used: Cochrane Library, EMBASE, Ovid Medline, PubMed, and Web of Science. Additionally, a manual search will be conducted through the references of the included articles. Results: The systematic review will summarize the current evidence on the prognostic value of TcPO₂ in DFU healing, identifying gaps in knowledge and potential areas for future research. Conclusions: The findings of this study may clarify the prognostic value of TcPO₂ in DFU healing, which could ultimately facilitate clinical management, decision-making, patient care, and potentially reduce treatment costs.

Keywords: blood gas monitoring; diabetic foot; foot ulcer; prognosis; transcutaneous.

Figure 1

A PRISMA flow diagram of the study selection process.

Figure 2

A flowchart of the study selection and assessment process. The figure outlines the methodological strategy, starting from the literature analysis and inclusion criteria, followed by the independent study assessment by two reviewers using the ROBINS-I, QUADAS-2, and STARD tools. Studies that meet the inclusion criteria proceed to the quality assessment, while excluded records are documented. In case of disagreement, a third reviewer evaluates the study to reach a final decision on inclusion.

Figure 3

A flowchart representation of the GRADE Approach in the Systematic Review Process. This diagram illustrates the sequential assessment of the included studies based on their design, applying ROBINS-I, STARD, or QUADAS-2 accordingly. Once individual studies are evaluated for risk of bias and methodological quality, the GRADE framework is used to assess the overall certainty of the evidence. GRADE considers key factors such as risk of bias, inconsistency, indirectness, imprecision, and publication bias to determine the confidence in the review’s conclusions. This final evaluation ensures the clinical applicability of the findings, supporting evidence-based decision-making.