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Table 2 Summary of the main secondary efficacy outcomes

From: Translational development of ABCB5+ dermal mesenchymal stem cells for therapeutic induction of angiogenesis in non-healing diabetic foot ulcers

Parameter

Full analysis set

(N = 23)

Per-protocol set

(N = 20)

Sourcea

Absolute wound surface area reduction

 Change from baseline at week 12 (cm2)b

1.7 (0.3–2.8)

2.0 (0.9–2.9)

Additional file 1: Table S7

Complete wound closure

 Patients with complete closure at week 12, n (%)

6 (26)

6 (30)

Additional file 1: Table S8

 Patients with complete closure at any time up to week 12, (%)

6 (26)

6 (30)

Additional file 1: Table S8

 Time to complete closure, daysc

Not reached

Not reached

Figure 7D

 ≥ 30% wound surface area reduction

 Patients with ≥ 30% reduction at week 12 (“Responders”), n (%)

17 (74)

17 (85)

Additional file 1: Table S8

 Patients with ≥ 30% reduction at any time up to week 12, n (%)

19 (83)

18 (90)

Additional file 1: Table S8

 Time to ≥ 30% reduction, daysc

27 (14; 30)

22 (14; 30)

Figure 7E

Reopening after complete wound closure

 Patients with wounds reopened at week 12, n (%)

0 (0)

0 (0)

n.a

Exudation

 Wounds with low exudation, n (%)

  Day 0

10 (44)

7 (35)

Additional file 1: Table S9

  Week 12

12 (52)

10 (50)

Additional file 1: Table S9

 Wounds with moderate exudation, n (%)

  Day 0

11 (48)

11 (55)

Additional file 1: Table S9

  Week 12

10 (44)

9 (45)

Additional file 1: Table S9

Amputation at target leg

 Patients with amputation, n (%)

1 (4)

1 (5)

n.a

 Time to amputation, days

42

42

n.a

Pain scoreb

 Day 0

1 (0–3)

n.a

Additional file 1: Table S10

 Week 12

1 (0–2)

n.a

Additional file 1: Table S10

Quality of lifed

 Dermatology Life Quality Indexb

  Day 0

6 (1–12)

n.a

Additional file 1: Table S11

  Week 12

4 (0–10)

n.a

Additional file 1: Table S11

  1. n.a. not applicable
  2. aDetailed results are given in Additional file 1: Tables S7–S11
  3. bMedian (interquartile range)
  4. cMedian (95%-CI)
  5. dDue to space limitations, SF-36 subscale scores (which remained virtually unchanged during the efficacy follow-up) are not shown here but given in Additional file 1: Table S11
  6. The median percentage wound surface area reduction was already statistically significant (p < 0.001) at 2 weeks and, except for the week-6 assessment (which was, however, missed by 4 patients), increased further over time (Fig. 7A, B)