Table 1 Demographics, wound size, revascularization and wound surgery before study start in the PP population
Baseline parameter of the PP population | NPWT | SMWC |
|---|---|---|
Study participants in the population, No. | 44 | 110 |
Age in years, Mean (SD) | 66.5 (11.0) | 67.8 (10.4) |
Sex, No. (%) | ||
Male | 29 (65.9) | 84 of 110 (76.4) |
Female | 15 (34.1) | 26 of 110 (23.6) |
Wound surface area at randomization calculated from CRF entries (width and length), mm2 | ||
Study participants with data available (used from screening), No. | 43 (1) | 110 (0) |
Mean (SD) | 964 (1392) | 878 (1266) |
Min-Max | 20 - 7536 | 12 - 7654 |
Wound volume at randomization calculated from CRF entries (width, length and depth), mm3 | ||
Study participants with data available (used from screening), No. | 43 (1) | 110 (0) |
Mean (SD) | 33,359 (95748) | 14,742 (36523) |
Min-Max | 94 - 602,880 | 0 - 306,150 |
Study participants with revascularization before study start, No. (%) | 1 (2.3) | 8 (7.3) |
Study participants with Percutaneous Transluminal Angioplasty (PTA), No. (%) | 0 of 1 (0) | 5 of 8 (62.5) |
Study participants with PTA and Stent, No. (%) | 0 of 1 (0) | 0 of 8 (0) |
Study participants with Venous Bypass, No. (%) | 1 of 1 (100) | 0 of 8 (0) |
Study participants with Polytetrafluoroethylene Bypass, No. (%) | 0 of 1 (0) | 1 of 8 (12.5) |
Study participants with Thromboendarterectomy, No. (%) | 0 of 1 (0) | 0 of 8 (0) |
Study participants with Thromboendarterectomy and Patch plastic, No. (%) | 0 of 1 (0) | 2 of 8 (25.0) |
Study participants with multi-level reconstruction, No. (%) | 0 of 1 (0) | 0 of 8 (0) |
Study participants with wound surgery at the study wound site before treatment start, No. (%) | 31 (70.5) | 83 (75.5) |
Study participants with surgical debridement, No. (%) | 13 of 31 (41.9) | 41 of 83 (49.4) |
Study participants with major amputations, No. (%) | 0 of 31 (0) | 0 of 83 (0) |
Study participants with minor amputations, No. (%) | 3 of 31 (9.7) | 19 of 83 (22.9) |
Study participants with minor amputations in the border zone to vital tissues, necrosectomy and debridement, No. (%) | 15 of 31 (48.4) | 23 of 83 (27.7) |