Assessment of the clinical outcome |
|
|
Aggravation |
No change |
Improvement |
|
Claudication |
Development of new ischemic foot lesion after WBMSC therapy |
No statistically significant difference of the pain-free walking distance |
Return to normal activity Statistically significant change of the pain-free walking distance |
Critical ischemia |
Ischemic rest pain |
Development of new ischemic foot lesion after WBMSC therapy Any amputation |
No change of ischemic rest pain |
Relief of ischemic rest pain |
|
Tissue loss |
Recurrence of a healed ischemic lesion Development of new ischemic foot lesion after complete wound healing Any amputation |
No change of ischemic foot wound |
Complete wound healing with or without planned debridement or amputation |
|
Assessment of the angiographic outcome |
|
|
-2 |
-1 |
0 |
+1 |
+2 |
|
Recanalization of run-off vessels |
≥50% progression of occlusion in the previous lengths of the run-off vessels |
<50% progression of occlusion in the previous length of the run-off vessels |
No change of the overall extent of the run-off vessels |
<50% segmental recanalization in the previous lengths of the run-off vessels |
≥50% segmental recanalization in the previous lengths of the run-off vessels |
Angiogenesis |
Any loss of firstorder collateral vessels |
Any loss of second-order collateral vessels |
No change of the overall extent of collateral vessels |
Development of more than second-order collateral vessels |
Development of first-order |
Arteriogenesis |
Decreased diameter and length of the pre-existing collateral vessels |
Decreased diameter or length of the pre-existing collateral vessels |
No change of the overall extent of collateral vessels |
Increased diameter or length of the pre-existing collateral vessels |
Increased diameter and length of the pre-existing collateral vessels |