| Odds.Ratio | Confidence.Interval | P.Value | |
|---|---|---|---|
| Fisher's Exact Test | 0.82 | 0.21 to 3.17 | 0.77 |
| Chi-Square Test | 0.97 |
BAART Analysis
Fisher’s Exact - Arm @ Primary Endpoint (V14)
- Odds Ratio of Timolol and Wound Healing by Primary Endpoint
Tests - WHR @ Primary Endpoint (V14)
| Test | Timolol_Mean_WHR | Placebo_Mean_WHR | P.Value |
|---|---|---|---|
| T-Test | 0.020 | 0.010 | 0.14 |
| Wilcoxon Test | 0.008 | 0.008 | 0.51 |
KM Healing Plots @ Primary Endpoint (V14)
KM Healing Plots @ Secondary Endpoint (V19)
T Test & Wilcoxon Test
Tests evaluating if there was a significant difference between start size and ulcer size at the primary endpoint in each arm.
T Test - Evaluating the Mean
Wilcoxon Test - Evaluating the Median
| Test | P.Value | |
|---|---|---|
| T Tests | ||
| Timolol | 0.115 | |
| Placebo | 0.201 | |
| Wilcoxon Tests | ||
| Timolol | 5e-04 | |
| Placebo | 0.012 |
Comparing between arms - wound size delta at primary endpoint.
| Value | Timolol | Placebo | P.Value | |
|---|---|---|---|---|
| T - Test | Mean | 1.03 | 0.51 | 0.30 |
| Wilcoxon Test | Median | 0.40 | 0.50 | 0.61 |
Chi-Squared and Fisher’s Exact, healing status @ Secondary Endpoint (V19)
- Odds Ratio: Timolol has an impact on healing at secondary endpoint.
| Odds.Ratio | Confidence.Interval | P.Value | |
|---|---|---|---|
| Fisher's Exact Test | 0.41 | 0.1 to 1.51 | 0.15 |
| Chi-Square Test | 0.21 |
Correlation of Wound Characteristics with Patient Characteristics
Reulceration Fisher’s Exact
- Odds Ratio: Timolol has an impact on reulceration.
| Odds.Ratio | Confidence.Interval | P.Value | |
|---|---|---|---|
| Fisher's Exact Test | 0.49 | 0.04 to 4.72 | 0.64 |
| Chi-Square Test | 0.77 |
Table 1
Continuous Variables
| Overall (N=48) |
|
|---|---|
| Age | |
| Mean (SD) | 67.6 (7.65) |
| Median [Min, Max] | 67.0 [50.0, 83.0] |
| First HgbA1c | |
| Mean (SD) | 8.51 (1.36) |
| Median [Min, Max] | 8.20 [5.90, 11.8] |
| Monofilament Score | |
| Mean (SD) | 1.46 (2.55) |
| Median [Min, Max] | 0 [0, 10.0] |
| Duration of Diabetes | |
| Mean (SD) | 18.1 (9.69) |
| Median [Min, Max] | 19.5 [1.00, 51.0] |
| DFU Severity Score | |
| Mean (SD) | 4.33 (2.05) |
| Median [Min, Max] | 3.00 [3.00, 11.0] |
| ABI | |
| Mean (SD) | 1.20 (0.222) |
| Median [Min, Max] | 1.18 [0.830, 2.04] |
| Missing | 8 (16.7%) |
| Toe Pressure | |
| Mean (SD) | 113 (29.5) |
| Median [Min, Max] | 110 [51.0, 196] |
| Missing | 12 (25.0%) |
| Charlson Comorbidity Index | |
| Mean (SD) | 2.67 (0.975) |
| Median [Min, Max] | 2.00 [2.00, 6.00] |
| Initial Ulcer Age (weeks) | |
| Mean (SD) | 24.0 (31.5) |
| Median [Min, Max] | 10.0 [3.00, 165] |
| Initial Ulcer Size (cm2) | |
| Mean (SD) | 1.67 (1.85) |
| Median [Min, Max] | 0.800 [0.300, 9.70] |
| Days to Primary Endpoint | |
| Mean (SD) | 80.5 (26.8) |
| Median [Min, Max] | 91.0 [21.0, 135] |
| Days to Secondary Endpoint | |
| Mean (SD) | 154 (78.2) |
| Median [Min, Max] | 191 [21.0, 267] |
| Missing | 3 (6.3%) |
| Endpoint 1: Ulcer Size (cm2) | |
| Mean (SD) | 0.925 (1.62) |
| Median [Min, Max] | 0.200 [0, 8.10] |
| Endpoint 2: Ulcer Size (cm2) | |
| Mean (SD) | 1.17 (3.49) |
| Median [Min, Max] | 0.100 [0, 22.7] |
| Missing | 2 (4.2%) |
| Endpoint 1: Wound Healing Rate (cm2/week) | |
| Mean (SD) | 0.106 (0.252) |
| Median [Min, Max] | 0.0600 [-0.190, 1.50] |
| Endpoint 2: Wound Healing Rate (cm2/week) | |
| Mean (SD) | 0.0864 (0.259) |
| Median [Min, Max] | 0.0300 [-0.550, 1.50] |
| Missing | 3 (6.3%) |
Discrete Variables
| Overall (N=48) |
|
|---|---|
| Smoking History | |
| Current | 4 (8.3%) |
| Former | 13 (27.1%) |
| Never | 31 (64.6%) |
| History of Amputation | |
| No | 27 (56.3%) |
| Yes | 20 (41.7%) |
| Missing | 1 (2.1%) |
| Pet Owner | |
| No | 30 (62.5%) |
| Yes | 13 (27.1%) |
| Missing | 5 (10.4%) |
| Ulcer Site | |
| 1-2 submet | 7 (14.6%) |
| 5 submet | 1 (2.1%) |
| digit 2 | 1 (2.1%) |
| hallux | 12 (25.0%) |
| heel | 4 (8.3%) |
| lateral | 3 (6.3%) |
| medial | 9 (18.8%) |
| sole | 8 (16.7%) |
| sub 2-3 met | 1 (2.1%) |
| Missing | 2 (4.2%) |
| Healed at Primary Endpoint | |
| No | 31 (64.6%) |
| Yes | 17 (35.4%) |
| Healed at Secondary Endpoint | |
| No | 22 (45.8%) |
| Yes | 26 (54.2%) |
| Race | |
| American Indian or Alaska Native | 1 (2.1%) |
| Asian | 1 (2.1%) |
| Black | 8 (16.7%) |
| Native Hawaiian or other Pasific Islander | 1 (2.1%) |
| Unknown | 2 (4.2%) |
| White | 35 (72.9%) |
| Reulceration During Study | |
| No | 43 (89.6%) |
| Yes | 5 (10.4%) |
| Study Arm | |
| Active | 21 (43.8%) |
| Placebo | 27 (56.3%) |
Continuous and Discrete Variables Compared by Arm
Continuous variables compared by T-Test
Discrete variables compared by Fisher’s Test
| Active (N=21) |
Placebo (N=27) |
P-value | |
|---|---|---|---|
| Age | |||
| Mean (SD) | 68.4 (7.49) | 66.9 (7.85) | 0.503 |
| Median [Min, Max] | 70.0 [56.0, 81.0] | 67.0 [50.0, 83.0] | |
| First HgbA1c | |||
| Mean (SD) | 8.68 (1.20) | 8.39 (1.48) | 0.449 |
| Median [Min, Max] | 8.20 [6.70, 11.0] | 8.20 [5.90, 11.8] | |
| Monofilament Score | |||
| Mean (SD) | 1.71 (3.16) | 1.26 (1.99) | 0.569 |
| Median [Min, Max] | 0 [0, 10.0] | 0 [0, 7.00] | |
| Duration of Diabetes | |||
| Mean (SD) | 17.3 (8.68) | 18.8 (10.5) | 0.593 |
| Median [Min, Max] | 15.0 [5.00, 37.0] | 21.0 [1.00, 51.0] | |
| ABI | |||
| Mean (SD) | 1.20 (0.186) | 1.20 (0.254) | 0.996 |
| Median [Min, Max] | 1.20 [0.920, 1.67] | 1.16 [0.830, 2.04] | |
| Missing | 2 (9.5%) | 6 (22.2%) | |
| Smoking History | |||
| Current | 1 (4.8%) | 3 (11.1%) | 0.385 |
| Former | 4 (19.0%) | 9 (33.3%) | |
| Never | 16 (76.2%) | 15 (55.6%) | |
| History of Amputation | |||
| No | 12 (57.1%) | 15 (55.6%) | 1 |
| Yes | 9 (42.9%) | 11 (40.7%) | |
| Missing | 0 (0%) | 1 (3.7%) | |
| Pet Owner | |||
| No | 12 (57.1%) | 18 (66.7%) | |
| Yes | 6 (28.6%) | 7 (25.9%) | |
| Missing | 3 (14.3%) | 2 (7.4%) | |
| Race | |||
| Asian | 1 (4.8%) | 0 (0%) | 0.706 |
| Black | 4 (19.0%) | 4 (14.8%) | |
| White | 16 (76.2%) | 19 (70.4%) | |
| American Indian or Alaska Native | 0 (0%) | 1 (3.7%) | |
| Native Hawaiian or other Pasific Islander | 0 (0%) | 1 (3.7%) | |
| Unknown | 0 (0%) | 2 (7.4%) | |
| Charlson Comorbidity Index | |||
| Mean (SD) | 2.76 (0.944) | 2.59 (1.01) | 0.553 |
| Median [Min, Max] | 2.00 [2.00, 4.00] | 2.00 [2.00, 6.00] | |
| DFU Severity Score | |||
| Mean (SD) | 4.10 (1.87) | 4.52 (2.19) | 0.474 |
| Median [Min, Max] | 3.00 [3.00, 9.00] | 4.00 [3.00, 11.0] | |
| Initial Ulcer Age (weeks) | |||
| Mean (SD) | 16.3 (18.2) | 30.0 (38.2) | 0.109 |
| Median [Min, Max] | 10.0 [3.00, 74.5] | 12.0 [4.00, 165] | |
| Initial Ulcer Size (cm2) | |||
| Mean (SD) | 1.71 (2.34) | 1.63 (1.41) | 0.885 |
| Median [Min, Max] | 0.800 [0.300, 9.70] | 1.20 [0.300, 5.50] | |
| Ulcer Site | |||
| 1-2 submet | 4 (19.0%) | 3 (11.1%) | |
| hallux | 5 (23.8%) | 7 (25.9%) | |
| heel | 2 (9.5%) | 2 (7.4%) | |
| lateral | 2 (9.5%) | 1 (3.7%) | |
| medial | 4 (19.0%) | 5 (18.5%) | |
| sole | 3 (14.3%) | 5 (18.5%) | |
| 5 submet | 0 (0%) | 1 (3.7%) | |
| digit 2 | 0 (0%) | 1 (3.7%) | |
| sub 2-3 met | 0 (0%) | 1 (3.7%) | |
| Missing | 1 (4.8%) | 1 (3.7%) | |
| Days to Primary Endpoint | |||
| Mean (SD) | 74.4 (30.1) | 85.3 (23.4) | 0.178 |
| Median [Min, Max] | 91.0 [21.0, 112] | 91.0 [40.0, 135] | |
| Days to Secondary Endpoint | |||
| Mean (SD) | 141 (75.5) | 165 (80.2) | 0.306 |
| Median [Min, Max] | 179 [21.0, 223] | 210 [40.0, 267] | |
| Missing | 1 (4.8%) | 2 (7.4%) | |
| Endpoint 1: Ulcer Size (cm2) | |||
| Mean (SD) | 0.681 (1.77) | 1.11 (1.51) | 0.374 |
| Median [Min, Max] | 0.100 [0, 8.10] | 0.300 [0, 4.40] | |
| Endpoint 2: Ulcer Size (cm2) | |||
| Mean (SD) | 0.463 (0.894) | 1.72 (4.54) | 0.181 |
| Median [Min, Max] | 0 [0, 3.75] | 0.300 [0, 22.7] | |
| Missing | 1 (4.8%) | 1 (3.7%) | |
| Endpoint 1: Wound Healing Rate (cm2/week) | |||
| Mean (SD) | 0.174 (0.352) | 0.0526 (0.115) | 0.141 |
| Median [Min, Max] | 0.0600 [-0.140, 1.50] | 0.0600 [-0.190, 0.430] | |
| Endpoint 2: Wound Healing Rate (cm2/week) | |||
| Mean (SD) | 0.154 (0.342) | 0.0324 (0.153) | 0.153 |
| Median [Min, Max] | 0.0600 [-0.0200, 1.50] | 0.0300 [-0.550, 0.430] | |
| Missing | 1 (4.8%) | 2 (7.4%) | |
| Healed at Primary Endpoint | |||
| No | 13 (61.9%) | 18 (66.7%) | 0.769 |
| Yes | 8 (38.1%) | 9 (33.3%) | |
| Healed at Secondary Endpoint | |||
| No | 7 (33.3%) | 15 (55.6%) | 0.153 |
| Yes | 14 (66.7%) | 12 (44.4%) | |
| Reulceration During Study | |||
| No | 18 (85.7%) | 25 (92.6%) | 0.641 |
| Yes | 3 (14.3%) | 2 (7.4%) |