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Table 2 Baseline characteristics of the ITT patients enrolled in the three treatment groups of the trial

From: A randomized controlled phase IIb wound healing trial of cutaneous leishmaniasis ulcers with 0.045% pharmaceutical chlorite (DAC N-055) with and without bipolar high frequency electro-cauterization versus intralesional antimony in Afghanistan

 

Intention to treat (ITT) evaluation

Test

 

Group I

Group II

Group III

Total

p-value

 

Male

14

12

15

41

 

Pearson Chi-Square

Female

10

17

13

40

0.446*

Test (Exact-Sig.)

Age (95% CI)

26 (19-33)

28 (23-33)

32 (25-38)

29 (25-32)

0.252*

Kruskal-Wallis Test

Lesion age (95% CI)

9 (7-10)

9 (8-11)

7 (6-8)

8 (7-9)

0.187*

Kruskal-Wallis Test

Lesion size (95% CI)

3.6 (2.3-4.9)

2.3 (1.7-3.0)

2.7 (1.8-3.6)

2.8 (2.3-3.4)

0.204*

Kruskal-Wallis Test

Parasite species

      

L. major

5

7

9

21

  

L. tropica

5

14

11

30

 

Pearson Chi-Square

Not determined

14

8

8

30

0.614*

Test (Exact-Sig.)

Lesion location

      

Head

5

4

4

13

  

Trunc

0

0

1

1

  

Upper extr.

12

19

16

47

 

Pearson Chi-Square

Lower extr.

7

5

7

19

0.799*

Test (Exact-Sig.)

Parasite load according to Giemsa staining

      

Low (+)

13

16

11

40

  

Moderate (++)

8

13

16

37

  

High (+++)

1

0

1

2

 

Pearson Chi-Square

Not determined

2

0

0

2

0.534*

Test (Exact-Sig.)

Biopsy prior to treatment

      

Evaluable

17

23

22

62

 

Pearson Chi-Square

Not evaluable

7

6

6

19

0.800*

Test (Exact-Sig.)

Parasite load/g tissue (SEM)

2.773 (1.554)x106

3.430 (1.736)x106

2.368 (1.526)x106

2.889 (0.932)x106

0.691*

Kruskal-Wallis Test

  1. Statistical tests were used as indicated (p < 0.05 indicates a significant proportion, * p-values refer to observations with complete information).