Baseline characteristics of 195 patients with diabetic foot ulcers who were randomized to treatment with continuous intrafemoral thrombolysis or conventional therapy
| Thrombolysis therapy (n=98) | Conventional therapy (n=97) | |
| General characteristics | ||
| Male | 71 (72.5%) | 69 (71.1%) |
| Age (years) | 72 (4.8) | 72 (4.6) |
| Diabetes duration (years) | 14 (3.0) | 14 (3.1) |
| BMI (kg/m²) | 27 (3.2) | 27 (3.0) |
| SBP (mm Hg) | 139 (11.8) | 139 (10.5) |
| DBP (mm Hg) | 82 (8.1) | 82 (6.3) |
| Current or ex-smoker | 25 (25.6%) | 22 (22.7%) |
| Clinical history | ||
| Previous non-traumatic amputation or diabetic skin ulcer | 2 (2.0%) | 2 (2.1%) |
| Previous cardiovascular disease | 66 (67.3%) | 63 (64.9%) |
| Neuropathy | 67 (68.4%) | 68 (70.1%) |
| NDS | 7.9 (2.1) | 7.7 (2.3) |
| Laboratory data | ||
| TC (mmol/L) | 5.2 (1.0) | 5.1 (0.9) |
| LDL-C (mmol/L) | 3.0 (0.8) | 3.0 (0.6) |
| HDL-C (mmol/L) | 1.2 (0.3) | 1.3 (0.3) |
| TG (mmol/L) | 2.1 (0.7) | 2.1 (0.7) |
| HbA1c (%) | 8.7 (1.4) | 8.5 (1.5) |
| FBG (mmol/L) | 9.5 (1.6) | 9.5 (1.7) |
| 2-hour BG (mmol/L) | 13.6 (3.1) | 14.2 (3.6) |
| Fibrinogen (g/L) | 4.7 (1.0) | 4.6 (1.0) |
| CR (μmol/L) | 85.2 (12.1) | 88.0 (10.4) |
| UACR (mg/g) | 111 (31.7) | 120 (39.1) |
| AST (U/L) | 47 (5.1) | 48 (6.1) |
| ALT (U/L) | 46 (4.5) | 47 (4.9) |
| Baseline medication | ||
| Aspirin | 71 (72.5%) | 75 (77.3%) |
| ACE inhibitor | 48 (50.0%) | 51 (52.6%) |
| Angiotensin-II receptor antagonist | 18 (18.4%) | 16 (16.55%) |
| Calcium channel blocker | 43 (43.9%) | 45 (46.4%) |
| Metformin | 68 (69.4%) | 70 (72.2%) |
| Sulfonylurea | 54 (55.1%) | 55 (56.8%) |
| Insulin | 52 (53.1%) | 51 (52.6%) |
| Statins | 40 (40.8%) | 38 (39.2%) |
| Clopidogrel | 15 (15.3%) | 13 (13.4%) |
| Wound conditions, Wagner grade | ||
| 1 | 12 (12.2%) | 15 (15.5%) |
| 2 | 31 (31.6%) | 29 (29.9%) |
| 3 | 55 (56.1%) | 53 (54.6%) |
| Ulcer size (cm2) | 8.1 (2.0) | 7.5 (1.8) |
| Ulcer duration (month) | 7.5 (2.0) | 7.4 (2.0) |
| ABI | 1.0 (0.2) | 1.0 (0.2) |
| TBI | 0.3 (0.1) | 0.3 (0.1) |
| TcPO2 (mm Hg) | 41.9 (9.5) | 41.9 (10.5) |
| Treated for ulcer infection prior to randomization | 22 (22.4%) | 24 (24.7%) |
Only first event for each patient counted in each row. Data are number (%), mean (SD). There were no statistically significant differences between the groups.
ABI, ankle-brachial index; ALT, alanine transaminase; AST, aspartate transaminase; BG, blood glucose; BMI, body mass index; CR, creatinine; DBP, diastolic blood pressure; FBG, fasting blood glucose; HbA1c, hemoglobin A1c; HDL-C, HDL-cholesterol; LDL-C, LDL-cholesterol; NDS, Neuropathy Deficit Score; SBP, systolic blood pressure; TBI, toe brachial index; TC, total cholesterol; TcPO2, transcutaneous oxygen tension; TG, triacylglycerol; UACR, urinary albumin/creatinine ratio.