Table 1.
Baseline demographics and clinical characteristics of unmatched and matched cohorts
| Unmatched Cohorts |
Propensity Score Matched Cohorts |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| Comparison #1 (C1) |
Comparison #2 (C2) |
Comparison #1 (C1) |
|||||||
| TWO2 N = 91 | NO TWO2 N = 111 | p | TWO2 ONLY N = 58 | OTHER TX ONLY N = 34 | p | TWO2 N = 70 | NO TWO2 N = 70 | p | |
| Patient demographics | |||||||||
| Age (years), mean (SD) | 66.9 (9.9) | 67.0 (8.7) | 0.93 | 67.7 (11.2) | 65.9 (6.5) | 0.33 | 67.5 (9.7) | 67.7 (8.4) | 0.89 |
| Sex, male, n (%) | 89 (97.8) | 107 (96.4) | 0.69 | 58 (100.0) | 34 (100.0) | NA | 68 (97.1) | 69 (98.6) | 1.0 |
| Ethnicity, n (%) | 0.092 | 0.084 | 0.61 | ||||||
| White | 51 (56.0) | 49 (44.1) | 33 (56.9) | 13 (38.2) | 37 (52.9) | 34 (48.6) | |||
| Non-White | 40 (44.0) | 62 (55.9) | 25 (43.1) | 21 (61.8) | 33 (47.1) | 36 (51.4) | |||
| Wound characteristics | |||||||||
| Wound classification, n (%) | <0.0001 | 0.0005 | 1.0 | ||||||
| Wagner 1 | 39 (42.9) | 38 (34.2) | 29 (50.0) | 8 (23.5) | 30 (42.9) | 30 (42.9) | |||
| Wagner 2 | 45 (49.5) | 39 (35.1) | 27 (46.6) | 15 (44.1) | 33 (47.1) | 33 (47.1) | |||
| Wagner 3 | 5 (5.5) | 25 (22.5) | 1 (1.7) | 8 (23.5) | 5 (7.1) | 4 (5.7) | |||
| Wagner 4 | 2 (2.2) | 9 (8.1) | 1 (1.7) | 3 (8.8) | 2 (2.9) | 3 (4.3) | |||
| Presenting area (cm2), mean (SD) | 3.8 (6.8) | 3.9 (7.1) | 0.95 | 3.2 (5.2) | 7.2 (11.1) | 0.056 | 3.3 (6.7) | 3.6 (7.8) | 0.80 |
| Wound duration (days), mean (SD) | 175.3 (241.7) | 166.9 (240.8) | 0.81 | 195.6 (271.0) | 267.4 (316.1) | 0.27 | 194.8 (269.8) | 188.6 (261.4) | 0.89 |
| Use of other treatments | |||||||||
| Used offloading devices, n (%) | 81 (89.0) | 97 (87.4) | 0.72 | 51 (87.9) | 30 (88.2) | 1.0 | 61 (87.1) | 61 (87.1) | 1.0 |
| Used NPWT, n (%) | 2 (2.2) | 9 (8.1) | 0.12 | 0 (0.0) | 9 (26.5) | <0.0001 | 2 (2.9) | 2 (2.9) | 1.0 |
| Used SS, n (%) | 31 (34.1) | 25 (22.5) | 0.068 | 0 (0.0) | 25 (73.5) | <0.0001 | 19 (27.1) | 19 (27.1) | 1.0 |
| Used GF, n (%) | 24 (26.4) | 22 (19.8) | 0.27 | 0 (0.0) | 22 (64.7) | <0.0001 | 16 (22.9) | 14 (20.0) | 0.68 |
| Other clinical characteristics | |||||||||
| Prior amputation, n (%) | 41 (45.1) | 31 (27.9) | 0.011 | 21 (36.2) | 11 (32.4) | 0.71 | 20 (28.6) | 20 (28.6) | 1.0 |
| Type 1 diabetes, n (%) | 5 (5.5) | 4 (3.6) | 0.73 | 5 (8.6) | 0 (0.0) | 0.15 | 2 (2.9) | 2 (2.9) | 1.0 |
| Type 2 diabetes, n (%) | 86 (94.5) | 107 (96.4) | 53 (91.4) | 34 (100.0) | 68 (97.1) | 68 (97.1) | |||
| Neuropathy, n (%) | 88 (96.7) | 107 (96.4) | 1.0 | 56 (96.6) | 33 (97.1) | 1.0 | 67 (95.7) | 67 (95.7) | 1.0 |
| Cardiovascular disease, n (%) | 69 (75.8) | 79 (71.2) | 0.46 | 45 (77.6) | 27 (79.4) | 0.84 | 51 (72.9) | 51 (72.9) | 1.0 |
| Peripheral artery disease, n (%) | 72 (79.1) | 90 (81.1) | 0.73 | 50 (86.2) | 26 (76.5) | 0.23 | 55 (78.6) | 54 (77.1) | 0.84 |
| Peripheral edema, n (%) | 22 (24.2) | 31 (27.9) | 0.55 | 14 (24.1) | 9 (26.5) | 0.80 | 15 (21.4) | 18 (25.7) | 0.55 |
| Venous disease, n (%) | 36 (39.6) | 36 (32.4) | 0.29 | 27 (46.6) | 12 (35.3) | 0.29 | 28 (40.0) | 27 (38.6) | 0.86 |
| Pain level, mean (SD) | 1.4 (2.3) | 2.4 (3.3) | 0.011 | 1.5 (2.1) | 3.0 (3.5) | 0.026 | 1.5 (2.4) | 2.4 (3.3) | 0.093 |
| Kidney disease stage, n (%) | <0.0001 | 0.0008 | <0.0001 | ||||||
| Normal | 1 (1.1) | 19 (17.1) | 0 (0.0) | 4 (11.8) | 1 (1.4) | 15 (21.4) | |||
| Stage I/II | 23 (25.3) | 24 (21.6) | 15 (25.9) | 6 (17.7) | 18 (25.7) | 11 (15.7) | |||
| Stage III | 45 (49.5) | 31 (27.9) | 32 (55.2) | 8 (23.5) | 36 (51.4) | 21 (30.0) | |||
| Stage IV/V | 12 (13.2) | 16 (14.4) | 5 (8.6) | 7 (20.6) | 9 (12.9) | 11 (15.7) | |||
| Dialysis | 10 (11.0) | 21 (18.9) | 6 (10.3) | 9 (26.5) | 6 (8.6) | 12 (17.1) | |||
| Diabetes duration (years), mean (SD) | 17.4 (9.9) | 18.0 (9.0) | 0.66 | 17.5 (11.5) | 18.9 (7.1) | 0.48 | 17.4 (9.8) | 17.4 (8.8) | 0.99 |
| HbA1c, mean (SD) | 8.0 (1.7) | 8.6 (2.2) | 0.053 | 7.9 (1.8) | 8.8 (2.1) | 0.038 | 7.8 (1.7) | 8.7 (2.5) | 0.0093 |
Comparison #1 (C1) compares patients who ever received TWO2 (TWO2) to those who never received TWO2 (NO TWO2). Patients in both cohorts may have also received other adjunctive therapy. Comparison #2 (C2) compares patients who only received TWO2 and no other adjunctive therapy (TWO2 ONLY) to those who received NPWT, SS, and/or GF, but not TWO2 (OTHER TX ONLY). Propensity score matching was performed on the following 9 factors; age, sex, ethnicity, wound severity, prior amputation, use of offloading, use of NPWT, use of SS, use of GF. All patients received appropriate SOC.
GF, growth factors; NPWT, negative pressure wound therapy; SD, standard deviation; SOC, standard of care; SS, skin substitutes.