Background
Objectives
Methods
Types of studies
Types of participants
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Ankle systolic pressure (ASP) < 80 mmHg
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Ankle-brachial index (ABI) < 0.8
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Toe systolic pressure < 40 mmHg
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Transcutaneous oxygen tension (TcO2) < 40 mmHg
Types of interventions
Types of outcome measures
Primary outcome
Secondary outcomes
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Amputation rate which includes patients that underwent a major or minor amputation during the interval between intervention and the end of follow-up
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Adverse events will also be tracked to assess safety. Both severe adverse events (e.g., those immediately life-threatening or causing hospitalisation, incapacity, nerve injury, acute limb ischemia, or death) and mild to moderate adverse events (e.g., infection at the surgical site, complications at the access site, acute limb ischemia) will be tracked
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Primary or secondary vessel patency will be assessed by angiographic or ultrasonographic methods. The treated vessel will be analysed to ensure no flow obstruction after the first intervention (primary patency) or after subsequent interventions (secondary patency)
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Mortality defined as any cause of death directly related to cardiovascular events or infectious complications of the disease will also be tracked
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Quality of life, measured by any validated questionnaire (e.g., SF-36) or by related information such as time away from work
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Total length of hospitalisation
Methods for search
Electronic searches
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Medical Literature Analysis and Retrieval System (MEDLINE via PubMed)
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Embase (via Elsevier)
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Cochrane Central Register of Controlled Trials - CENTRAL (via Wiley)
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Indice Bibliográfico Español de Ciencias de la Salud – IBECS (via Virtual Health Library)
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Latin American and Caribbean Center on Health Sciences Information – LILACS (via Virtual Health Library)
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Cumulative Index to Nursing and Allied Health Literature (CINAHL)
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The Allied and Complementary Medicine Database (AMED)
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World Health Organization International Clinical Trials Registry Platform (www.who.int/ictrp/en/)
1 | “Leg Ulcer”[Mesh] or (Leg Ulcer*) or (lower limb ulcer) |
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2 | “Foot Ulcer”[Mesh] or (Foot Ulcer*) or (Plantar Ulcer*) or “below the knee ulcer” |
3 | “Diabetic Foot”[Mesh] or (Foot Diabetic) or (Diabetic Feet) or (Foot Ulcer Diabetic) or diabet* |
4 | “Peripheral Arterial Disease”[Mesh] or (Arter* Disease* Peripheral) or “critical limb ischemia” |
5 | “Diabetes Complications”[Mesh] or (Diabet* Complication*) or (Diabetes-Related Complication*) or (Diabetes Related Complication*) or (Complication* of Diabetes Mellitus) or (Diabetes Mellitus Complication*) |
6 | “Peripheral Vascular Diseases”[Mesh] or (Disease* Peripheral Vascular) or (Peripheral Angiopath*) |
7 | 1 or 2 or 3 or 4 or 5 or 6 |
8 | “Stents”[Mesh] or stent* |
9 | “Drug-Eluting Stents”[Mesh] or (Drug Eluting Stent*) or (Drug-Eluting Stent*) or (Drug-Coated Stent*) or (Drug Coated Stent*) |
10 | “Self Expandable Metallic Stents”[Mesh] or (Self Expandable Metal* Stent*) |
11 | “Angioplasty”[Mesh] or Angioplast* or (Endoluminal Repair*) or (Percutaneous Transluminal Angioplast*) or (Transluminal Angioplast*) |
12 | “Angioplasty, Balloon, Laser-Assisted”[Mesh] or (Laser Balloon Angioplast*) or (Laser-Assisted Angioplast*) or (Laser Assisted Angioplast*) or (Angioplast* Transluminal Percutaneous Laser) or (Laser-Assisted Balloon Angioplast*) or (Laser Assisted Balloon Angioplast*) or (Percutaneous Transluminal Laser Angioplast*) |
13 | “Angioplasty, Laser”[Mesh] or (Laser Angioplast*) |
14 | “Angioplasty, Balloon”[Mesh] or (Dilation* Transluminal Arter*) or (Balloon Angioplast*) |
15 | revascular* or (drug-coated balloon) |
16 | “Endovascular Procedures”[Mesh] or (Endovascular Procedure*) or (Intravascular Procedure*) or (Intravascular Technique*) or (Endovascular Technique*) |
17 | 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 |
18 | 7 and 17 |
19 | 18 AND (Therapy/Broad[filter]) |
Hand search
Selection of studies
Data extraction and management
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Methods, including study design, the total duration of study and period of carryout, number and location of study centres, research setting, withdrawals, and date of study
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Participants, including total number, age aspects (e.g., mean, range), gender, the severity of the condition, diagnostic, and inclusion and exclusion criterion
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Interventions, including direct interventions, intervention comparison, concomitant medications, and excluded medications
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Outcomes, including planned and final primary and secondary outcomes and time points reported
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Notes, including trial funding for trial and notable conflicts of interest for trial authors.
Assessment of risk of bias in included studies
Measures of treatment effect
Unit of analysis issues
Dealing with missing data
Assessment of heterogeneity
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0 to 40%: might not be important
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30 to 60%: may represent moderate heterogeneity
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50 to 90%: may represent substantial heterogeneity
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75 to 100%: considerable heterogeneity