Table 2 GRADE evidence profile for the outcomes
Certainty assessment | No. of patients | Effect | Quality of evidence | Importance | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
No. of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Publication bias | Stem cell therapy | Control | (95% CI) | ||
ABI | |||||||||||
16 | RCT | No serious limitations | Serious limitations | No serious limitations | No serious limitations | Yes | 396 | 443 | MD 0.13 (0.10, 0.17) | ⨁⨁◯◯低 | Important |
TcO2 | |||||||||||
8 | RCT | No serious limitations | Serious limitations | No serious limitations | No serious limitations | No | 217 | 258 | MD 12.62 (5.73, 19.51) | ⨁⨁◯◯低 | Important |
Major amputation rate | |||||||||||
8 | RCT | No serious limitations | No serious limitations | No serious limitations | Serious limitations | Yes | 49/232 (21.1%) | 60/197 (305%) | OR 0.66 (0.42, 1.03) | ⨁⨁◯◯低 | Key |
Amputation rate | |||||||||||
16 | RCT | No serious limitations | No serious limitations | No serious limitations | Serious limitations | Yes | 88/425 (20.7%) | 142/444 (32.0%) | OR 0.50 [0.36, 0.69] | ⨁⨁◯◯低 | Key |
Ulcer healing rate | |||||||||||
14 | RCT | No serious limitations | No serious limitations | No serious limitations | Serious limitations | No | 170/313 (54.3%) | 90/310 (29.0%) | OR 4.31 [2.94, 6.30] | ⨁⨁◯◯低 | Key |
Rest pain score | |||||||||||
9 | RCT | No serious limitations | Serious limitations | No serious limitations | No serious limitations | No | 260 | 298 | MD − 1.61 [− 2.01, − 1.21] | ⨁⨁◯◯低 | Important |
Pain-free walking distance | |||||||||||
3 | RCT | No serious limitations | No serious limitations | No serious limitations | Serious limitations | No | 48 | 49 | MD 178.25 [128.18, 228.31] | ⨁⨁◯◯低 | Important |