Table 2.
Patients and ulcers’ characteristics at baseline*
| Control (n = 60) | NOSF (n = 57) | Total (n = 117) | |
|---|---|---|---|
| Sex (F/M) | 36/24 | 33/24 | 69/48 |
| Age (years) | 71·0 ± 13·9 | 71·5 ± 13·1 | 71·3 ± 13·5 |
| Weight (kg) | 84·7 ± 26·2 | 81·2 ± 21·8 | 83·0 ± 24·2 |
| Height (cm) | 168·3 ± 9·5 | 168·0 ± 10·6 | 168·2 ± 10·0 |
| BMI (kg/m2) | 29·8 ± 8·7 | 28·6 ± 6·8 | 29·3 ± 7·8 |
| BMI ≥ 30 kg/m2, n (%) | 26 (43·3) | 20 (35·1) | 46 (39·3) |
| History of vein thrombosis, n (%) | 23 (38·3) | 22 (38·6) | 45 (38·5) |
| Diabetes, n (%) | 12 (20·0) | 6 (10·5) | 18 (15·4) |
| Outpatients, n (%) | 52 (86·7) | 44 (77·2) | 96 (82·1) |
| ABPI | 1·03 ± 0·17 | 1·01 ± 0·10 | 1·02 ± 0·14 |
| Compression bandage wearing, n (%)† | 57 (95·0) | 50 (87·7) | 107 (91·5) |
| Ulcer characteristics | |||
| Recurrent ulcer, n (%) | 40 (66·7) | 31 (54·4) | 71 (60·7) |
| Ulcer duration, months (median) | 12·1 ± 7·7 (12·0) | 10·4 ± 7·1 (8·0) | 11·2 ± 7·4 (10·0) |
| Duration >6 months, n (%) | 35 (58·3) | 31 (54·4) | 66 (56·4) |
| Stagnating/worsening ulcer, n (%) | 43 (71·7) | 37 (64·9) | 80 (68·4) |
| Ulcer area, cm2 (median) | 10·4 ± 8·4 (7·9) | 11·4 ± 10·1 (9·0) | 10·9 ± 9·3 (8·1) |
| Surface area ≥10 cm2, n (%) | 22 (36·7) | 26 (45·6) | 48 (41·0) |
| Condition of the perilesional skin, n (%) | |||
| Healthy | 10 (16·7) | 4 (7·0) | 14 (12·0) |
| Erythematous | 30 (50·0) | 30 (52·6) | 60 (51·3) |
| Oedematous | 10 (16·7) | 14 (24·6) | 24 (20·5) |
| Eczematous | 8 (13·3) | 9 (15·8) | 17 (14·5) |
| Others | 16 (26·7) | 17 (29·8) | 33 (28·2) |
| Ulcer aetiology, n (%) | |||
| Venous | 32 (53·3) | 32 (56·1) | 64 (54·7) |
| Post‐phlebitic | 12 (20·0) | 8 (14·0) | 20 (17·1) |
| Arterial participation | 16 (26·7) | 17 (29·8) | 33 (28·2) |
ABPI, ankle brachial pressure index; BMI, body mass index; NOSF, nano‐oligosaccharide factor.
*
Results are presented as mean ± SD or as indicated.
†
After study inclusion, all patients except one in each group received compression.