Table 4 Key Characteristics of Included Studies
Fossaceca et al., 2013 [36] | Söderström et al., 2013 [37] | AcÃn et al., 2014 [38] | Lejay et al., 2014 [39] | Jeon et al., 2016 [40] | |
|---|---|---|---|---|---|
Participants | Italy, single-centre Retrospective, non-randomised Study period: 2005–2011 • 201 subjects (201 limbs) • Mean age: 75.5 (range 66–85) • PAD anatomical locations: Isolated BTK lesions • All foot ulcers | Finland, single-centre Retrospective, non-randomised Study period: 2007–2011 • 226 subjects (250 limbs) • Mean age: 71.1 (range 56.5–84.9) • PAD anatomical locations: Isolated infrapopliteal lesions • Ulcers distal to malleolus | Spain, single-centre Retrospective, non-randomised Study period: 1999–2009 • 92 subjects (101 limbs) • Mean age: 72 (range 64–77) • PAD anatomical locations: Femoropopliteal & infrapopliteal lesions • All foot ulcers | France, single-centre Retrospective, non-randomised Study period: 2003–2009 • 54 subjects (58 limbs) • Mean age: 69.1 (range 58–81) • PAD anatomical locations: Isolated BTK lesions • Ulcers distal to malleolus | South Korea, unspecified number of centres Retrospective, non-randomised Study period: 2011–2013 • 70 subjects (82 limbs) • Mean age: 69.6 (range 59.6–79.6) • PAD anatomical locations: Isolated infrapopliteal lesions • Ulcers distal to calcaneus |
Diagnostic criterion for diabetes | Diagnostic criterion unstated in-text, however the following information was tabulated: • Time from diagnosis of diabetes: 12.5 ± 5.2 years • HbA1c (%): 7.9 ± 1.6 • Insulin therapy: 113 (56.2%) | • On hyperglycaemia reducing diet • Taking oral hypoglycaemic drugs • Undergoing insulin treatment | • Baseline blood glucose levels >120 g/dL, or • Require treatment with hypoglycaemic drugs | — | Diagnostic criterion unstated, however the following information was provided: • Mean duration of diabetes: 17.1 ± 9.7 years (range 1–50) • HbA1c (%): 8.5 ± 1.9 |
Intervention | Angioplasty: PTA • Primary endoluminal approach • Secondary subintimal approach | Angioplasty: PTA • Primary intraluminal approach | Stents used selectively Angioplasty: PTA • Primary endoluminal approach | Bypass • Autologous saphenous vein conduits only | Angioplasty: PTA • Primary intraluminal approach • Secondary subintimal approach |
Guiding principle for interventions | Angiosome concept • i.e. all patients primarily considered for DR, subsequently undergoing IR when all DR options was not technically feasible | Best vessel strategy • i.e. retrospective grouping of patients into DR or IR, determined if the best quality vessel utilised supplied the ischaemic site via a source artery or via existing collaterals | Best vessel strategy • i.e. retrospective grouping of patients into DR or IR, determined if the best quality vessel utilised supplied the ischaemic site via a source artery or via existing collaterals | Angiosome concept • i.e. all patients primarily considered for DR, subsequently undergoing IR when DR was not technically feasible | Angiosome concept • i.e. all patients primarily considered for DR, subsequently undergoing IR when all DR options was not technically feasible |
Pre-revascularisation care | |||||
 - Wound care | • Debridement of necrotic tissue | Local wound care tailored to lesion characteristics. • Debridement of devitalised tissue, surgical revision and indicated microbial therapy for infected ulcers; negative-pressure wound therapy and off-loading where indicated. | • Early debridement, abscess drainage, minor amputations, and wet dressings. | — | • Unstated. |
 - Medications | • Prophylaxis broad-spectrum antibiotic therapy • (The antibiotic utilised and the route of administration unstated.) • Dual anti-platelet therapy (Aspirin 100 mg/day, Clopidogrel 75 mg/day). | • Aspirin (100 mg/day), if not contraindicated. | • Broad-spectrum antibiotic therapy for severe infections in accordance with a general protocol. • (Protocol unstated, hence the drug utilised as well as the route of administration is not known.) | — | • Dual anti-platelet therapy at least 72 h before the procedure. (Aspirin 100 mg/day, Clopidogrel 75 mg/day) |
Post-revascularisation care | |||||
 - Medications | • Dual anti-platelet therapy maintained (Aspirin 100 mg/day and Clopidogrel 75 mg/day) for 6 weeks, then Aspirin alone indefinitely. | • Lifelong Aspirin therapy, accompanied by Clopidogrel (75 mg/day) for 3 months after PTA | — | — | • Dual anti-platelet therapy maintained (Aspirin 100 mg/day and Clopidogrel 75 mg/day) once daily for at least 3 months if there were no contraindications to either drug. |
Outcome measures | |||||
 - Wound healing | ✓ | ✓ | ✓ | ✓ | ✓ |
partial/complete at 1, 6, 12 months | at 12 months | at 12 months | at 3, 6, 12 months | at 12 months | |
 - Limb salvage | ✓ | ✓ | ✓ | ✓ | ✓ |
at 1, 6, 12 months | at 12 months | at 24 months | at 12 months | at 12, 24 months | |
 - Additional measures | Amputation (minor and major), Average TcPO2, Mortality, PTA retreatment, Restenosis, Technical success | AFS, AFS with healed ulcer, Median time to ulcer healing, Survival, Vascular Re-intervention | AFS, Major amputation at 30 days, MACE, MALE, Freedom from MALE + POD, Freedom from RAS, Freedom from RAO, Overall survival at 24 months | Median Ulcer Healing Time, Primary Patency, Survival, TcPO2 | Amputation, Angiosome Score, Major and minor complications, Mortality, PTA reintervention, Technical Success, Wound Healing Time |
Wound classification | — | UTWCS | — | UTWCS | Wagner |
Presence of infection accounted for | — | ✓ | Graded according to CDC/NHSN surveillance definition [81] | ✓ | — |
Follow-up (months) | • Protocol: 1, 6, 12 • Mean: 17.5 • Range 5.5–29.5 | • Protocol: 1 month, and at 1–3 months thereafter depending on clinical condition of the foot • Mean: — • Range: — Surveillance of ulcer continued until healing occurred, with follow-up ending 1 year after intervention or death whichever occurred first. | • Protocol: 1, 3 and every 6 months thereafter. • Median: 19 • Range: 9–38 | • Protocol: 1, 3, and every 6 months thereafter. • Mean: 20 • Range: 4–36 | • Protocol: 12, 24 • Mean: 13 • Range: 0–25 The status of the wound was regularly checked until complete healing occurred. |
Main findings: wound healing rate | No statistically significant difference found in therapeutic efficacy. (p-values: —) | • DR had a highly statistically significant improvement in wound healing rates at 12 months (p < 0.001) • Results were still highly statistically significant after adjustments with propensity score (HR 1.97; 95% CI, 1.34–2.90) (p = 0.001) | • DR had a highly statistically significant improvement in wound healing rates as compared to IR ‘without collaterals’ group at 12 months (p = 0.001) • No statistically significant differences were found between DR and IR ‘through collaterals’ groups for wound healing at 12 months (p = 0.38) | • DR had a statistically significant improvement in wound healing rates as compared to IR at 3, 6 and 12 months (p = 0.04) | • DR had a statistically significant improvement in wound healing rates as compared to IR at 12 months (p < 0.05) |
Strengths of study | • TASC-II diagnostic criteriona for CLI satisfied • Complete follow-up of all subjects • Diagnostic criteria of diabetes indicated • Subjects’ duration of diabetes provided | • TASC-II diagnostic criteriona for CLI satisfied • Complete follow-up of all subjects • Diagnostic criteria of diabetes indicated • Consecutive sample • Employment of wound classification system • Presence of infection accounted for • Use of propensity score | • TASC-II diagnostic criteriona for CLI satisfied • Diagnostic criteria of diabetes indicated • Consecutive sample • Presence of infection accounted for • Comparable baseline characteristics of subjects between groups | • TASC-II diagnostic criteriona for CLI satisfied • Complete follow-up of all subjects • Consecutive sample • Employment of wound classification system • Presence of infection accounted for • Comparable baseline characteristics of subjects between groups | • TASC-II diagnostic criteriona for CLI satisfied • Diagnostic criteria of diabetes indicated • Subjects’ duration of diabetes provided • Employment of wound classification system |
Limitations of study | • Non-consecutive sample • Wound classification system not employed • Presence of infection not accounted for • Omission of subjects’ baseline characteristics | • No data on subjects’ duration of diabetes | • No data on subjects’ duration of diabetes • Drop-outs unaccounted • Wound classification system not employed • Patients with ESRD excluded | • No data on diagnostic criteria for diabetes • No data on subjects’ duration of diabetes | • Drop-outs unaccounted • Non-consecutive sample • Presence of infection not accounted for • Omission of subjects’ baseline characteristics |
NOS scores | 6/9 | 8/9 | 5/9 | 7/9 | 5/9 |