TABLE 1.
Baseline socio‐demographic and clinical characteristics by treatment group at randomisation
| Standard care | Spray‐on skin | P value | |
|---|---|---|---|
| N | 25 | 24 | |
| Age at randomisation (years) | 58.1 ± 12.5 | 61.5 ± 14.3 | .375 |
| Male (%) | 84.0 | 79.2 | .725 |
| Aboriginal (%) | 4.0 | 4.2 | >.999 |
| Smoking status (%) | >.999 | ||
| Never | 44.0 | 45.8 | |
| Ex‐ | 48.0 | 45.8 | |
| Current | 8.0 | 8.3 | |
| Ulcer side (% right) | 36.0 | 58.3 | .156 |
| Type 2 diabetes (%) | 84.0 | 83.3 | >.999 |
| Diabetes duration (years) | 17.0 [15.5‐29.0] | 25.5 [11.5‐30.8] | .787 |
| HbA1c (%) | 8.4 [7.5‐9.4] | 7.6 [6.6‐9.2] | .129 |
| BMI (kg/m2) | 32.7 ± 7.6 | 30.9 ± 6.2 | .363 |
| Palpable DP pulse (%) | 64.0 | 54.2 | .567 |
| Palpable PT pulse (%) | 40.0 | 58.3 | .258 |
| Loss of sensation (%) | 92.0 | 100 | .490 |
| Hypertension (%) | 80.0 | 75.0 | .742 |
| Ischaemic heart disease (%) | 40.0 | 37.5 | >.999 |
| Intermittent claudication (%) | 16.0 | 25.0 | .496 |
| Prior revascularisation (%) | 16.0 | 29.2 | .321 |
| Prior diabetic foot infection (%) | 52.0 | 79.2 | .072 |
| Prior foot deformity (%) | 25.0 | 16.7 | .724 |
| Prior healed diabetes‐related foot ulcer (index limb, %) | 48.0 | 62.5 | .393 |
| Prior minor lower extremity amputation (%) | 32.0 | 58.3 | .088 |
| Prior major lower extremity amputation (%) | 4.0 | 0 | >.999 |
| Neuropathy (%) | 100 | 95.8 | .490 |
| Retinopathy (%) | 44.0 | 33.3 | .561 |
| Nephropathy (%) | 28.0 | 29.2 | >.999 |
| CKD stage (%): | .159 | ||
| No CKD or Stage 1 | 68.0 | 41.7 | |
| Stage 2 or Stage 3A | 8.0 | 12.5 | |
| Stage 3B or worse | 24.0 | 45.8 | |
| Immunosuppressed (%) | 4.0 | 0 | >.999 |
| Cirrhosis/hepatic failure (%) | 0 | 4.2 | |
| Index wound area (cm2) | 15.3 [9‐23.8] | 11 [8.4‐15.3] | .27 |
| Location of index wound (%): | |||
| Fore | 72.0 | 79.2 | .742 |
| Mid | 16.0 | 4.2 | .349 |
| Hind | 12.0 | 16.7 | .702 |
| Index wound on dorsal surface (%) | 44.0 | 33.3 | .561 |
| Index wound on plantar surface (%) | 36.0 | 29.2 | .762 |
| Surgical procedure prior to randomisation (%) | .43 | ||
| Minor amputation | 60.0 | 70.8 | |
| Surgical or low‐frequency ultrasonic debridement | 40 | 29.2 | |
| WIfI amputation risk (20): | .566 | ||
| Very low (%) | 56 | 58.3 | |
| Low (%) | 36 | 41.7 | |
| Moderate (%) | 4 | 0 | |
| High (%) | 4 | 0 | |
| Index wound pedis depth (%) | .394 | ||
| Superficial | 44.0 | 58.3 | |
| Involving subcutaneous structures | 52.0 | 33.3 | |
| Involving bone/joint | 4.0 | 8.3 | |
| EQ‐5D‐5L: | |||
| Any mobility problems (%) | 76.0 | 75.0 | >.999 |
| Any problems with self‐care (%) | 24.0 | 25.0 | >.999 |
| Any problems with doing usual activities (%) | 64.0 | 70.8 | .762 |
| Any pain or discomfort (%) | 56.0 | 62.5 | .773 |
| Any anxiety or depression (%) | 28.0 | 37.5 | .551 |
| VAS score | 75 [50‐88] | 78 [52‐89] | .936 |
| Pressure offloading (%): | .297 | ||
| Below knee removable device (%) | 32.0 | 16.7 | |
| Stiff‐soled ankle height shoe (%) | 68.0 | 79.2 | |
| Wheelchair (%) | 0 | 4.2 | |
Note: Baseline data are summarised as means ± SD, median [interquartile range] or percentages. WIfI, Wound, Ischemia, and foot Infection. 20