Table 1 Detailed description of the inclusion/exclusion criteria

Language

French, Dutch and English

Any language other than French, Dutch or English

Publication year

From 01/01/2011 to 03/03/2020

31/12/2010 or earlier

Study type

A clinical research study that evaluates interventions on health-related outcomes, whose full-text article could be retrieved from the KU Leuven Libraries collection with institutional access or whose full report was registered or indexed on the platform ClinicalTrials.gov

1) Case reports, conference abstracts, study protocols, letter, editorial, comment, note

2) A clinical trial registered on the platform ClinicalTrial.gov, whose the status has not been reported as “completed”

Study domain

Studies reporting interventions that address the following domains of diabetic foot care:

• organization of care

• wound healing interventions

• peripheral artery disease (PAD)

• offloading

• prevention of foot ulcer in people with diabetes with active or history of foot ulceration (secondary prevention)

Studies reporting interventions that address the following domains of diabetic foot care:

• diagnosis and treatment of foot infection (antimicrobial therapy, adjunctive treatment and surgical treatment)

• prevention of foot ulcer in people with diabetes without active/history of foot ulceration (primary prevention)

Study design

1) Studies designed with a control group (randomized

or non-randomized)

2) Systematic reviews of controlled studies, with or without meta-analysis

1) Studies addressing the wound healing interventions or offloading domain which, based on the reported study design, do not provide high quality evidence (level of evidence^a > 2)

2) Studies which, based on the reported study design, do not provide quality evidence of at least level 3—e.g. case–control, case series, etc

3) Systematic reviews of a combination of studies with eligible and non-eligible designs

4) Systematic reviews which do not provide a summarized conclusion (pooled results or general statements) about the effect of the intervention

Population

1) People with diabetes:

• with active diabetic foot ulceration (DFU) or history of DFU, it includes the different stages of the complication: critical limb ischemia (CLI)—infection/osteomyelitis—gangrene

• having surgical wounds subsequent to a DFU (post-operative wound)

2) Mixed or more comprehensive study population (e.g. chronic wounds, PAD patients) where the eligible study population is specifically studied

1) People with diabetes (non-exhaustive list): with Charcot foot, venous ulcer, claudication, amputation not due to a DFU, acute limb ischemia, etc

2) Mixed or more comprehensive study population (e.g. chronic wounds, PAD patients) where the eligible study population was not specifically studied

Intervention

Interventions in patients with active or history of DFU at the level of:

1) organization of diabetic foot care

or 2) delivery of diabetic foot care (diagnostic, treatment, secondary prevention),

measuring a change in outcomes related to the patient or to the foot/limb or to the healthcare costs

1) Interventions which do not fit into the intervention groups extracted from the literature

2) Interventions reported by only one single study (not related to organization of care)

3) Interventions related to the administration of patient-reported outcome instruments

Outcome

Quantitative outcomes:

1) related to the foot/limb: ulcer healing, minor amputation, major amputation, change in ulcer area, post-operative wound healing, ulcer recurrence, ulcer incidence

2) related to the patient: survival, amputation-free survival, patient-reported outcome measures (PROMs), quantified care experiences (e.g. PREMs)

3) related to healthcare costs: length of stay, cost-effectiveness, quality-adjusted life year (QALY)

Results for which a measure of the statistical significance is not reported