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Table 1 Baseline characteristics of the PP 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

 

Per protocol (PP) evaluation

Test

Group I

Group II

Group III

Total

p-value

 

Male

13

8

11

32

 

Pearson Chi-Square

Female

10

15

12

37

0.372*

Test (Exact-Sig.)

Age (95% CI)

26 (19-34)

28 (22-33)

33 (25-40)

29 (25-33)

0.308*

Kruskal-Wallis Test

Lesion age (95% CI)

9 (7-11)

8 (7-10)

7 (6-9)

8 (7-9)

0.437*

Kruskal-Wallis Test

Lesion size (95% CI)

3.7 (2.3-5.0)

2.5 (1.7-3.3)

3.0 (2.0-4.1)

3.1 (2.5-3.7)

0.421*

Kruskal-Wallis Test

Parasite species

      

L. major

4

5

7

16

  

L. tropica

5

13

10

28

 

Pearson Chi-Square

Not determined

14

5

6

25

0.664*

Test (Exact-Sig.)

Lesion location

      

Head

5

3

2

10

  

Trunc

0

0

1

1

  

Upper extr.

12

16

14

42

 

Pearson Chi-Square

Lower extr.

6

4

6

16

0.666*

Test (Exact-Sig.)

Parasite load according to Giemsa staining

      

Low (+)

12

11

8

31

  

Moderate (++)

8

12

14

34

  

High (+++)

1

0

1

2

 

Pearson Chi-Square

Not determined

2

0

0

2

0.541*

Test (Exact-Sig.)

Biopsy prior to treatment

      

Evaluable

16

18

17

51

 

Pearson Chi-Square

Not evaluable

7

5

6

18

0.940*

Test (Exact-Sig.)

Parasite load/g tissue (SEM)

2.944 (1.645) × 106

3.081 (1.980) × 106

2.773 (1.785) × 106

2.935 (1.032) × 106

0.636*

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).