Trial Outcomes & Findings for An RCT to Evaluate the Effect of a New Skin Care Regimen on SBF in Those With Podoconiosis (NCT NCT02839772)
NCT ID: NCT02839772
Last Updated: 2017-01-06
Results Overview
Trans-epidermal water loss (TEWL) was measured with a Vapometer (non-invasive probe) on the outer lower leg 8 cms below the head of the fibula. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.
COMPLETED
PHASE3
193 participants
Change from baseline following 3 months of intervention
2017-01-06
Participant Flow
Participant milestones
| Measure |
Current Skin Care Regimen
Legs/feet washed daily for 3 months with soapy water, soaked in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
|
Current Skin Regimen Plus 2% Glycerine
Legs/feet washed daily for 3 months with soapy water, soaked in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
96
|
|
Overall Study
COMPLETED
|
96
|
96
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An RCT to Evaluate the Effect of a New Skin Care Regimen on SBF in Those With Podoconiosis
Baseline characteristics by cohort
| Measure |
Current Skin Care Regimen
n=97 Participants
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
|
Current Skin Regimen Plus 2% Glycerine
n=96 Participants
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
|
Total
n=193 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
84 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Gender
Female
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Gender
Male
|
48 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Region of Enrollment
Ethiopia
|
97 participants
n=5 Participants
|
96 participants
n=7 Participants
|
193 participants
n=5 Participants
|
|
Severity of podoconioisis based on a staging systeme
Less severe/moderate disease
|
47 participants
n=5 Participants
|
46 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
Severity of podoconioisis based on a staging systeme
Severe disease
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline following 3 months of interventionPopulation: 3 month post intervention data was missing from one male participant in the control group. One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.
Trans-epidermal water loss (TEWL) was measured with a Vapometer (non-invasive probe) on the outer lower leg 8 cms below the head of the fibula. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.
Outcome measures
| Measure |
Control Group
n=193 Legs
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
Experimental Group
n=190 Legs
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
|---|---|---|
|
Change in TEWL at Top of Outer Lower Legs
Right leg TEWL at 1st visit
|
12.74 g/m2/h
Standard Deviation 4.73
|
13.43 g/m2/h
Standard Deviation 5.56
|
|
Change in TEWL at Top of Outer Lower Legs
Left leg TEWL at 1st visit
|
13.52 g/m2/h
Standard Deviation 5.61
|
13.27 g/m2/h
Standard Deviation 4.91
|
|
Change in TEWL at Top of Outer Lower Legs
Right leg TEWL at 4th visit
|
8.76 g/m2/h
Standard Deviation 2.63
|
7.06 g/m2/h
Standard Deviation 1.96
|
|
Change in TEWL at Top of Outer Lower Legs
Left leg TEWL at 4th visit
|
9.09 g/m2/h
Standard Deviation 2.63
|
7.53 g/m2/h
Standard Deviation 2.12
|
PRIMARY outcome
Timeframe: Change from baseline following 3 months of interventionPopulation: 3 month post intervention data missing from one male participant in the control group. One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.
Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the outer lower leg. This was mid-way between the measurement site at the top of the outer leg and the site at the base of the outer lower leg. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.
Outcome measures
| Measure |
Control Group
n=193 Legs
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
Experimental Group
n=190 Legs
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
|---|---|---|
|
Change in TEWL at Mid-point Outer Lower Legs
Right leg TEWL at 1st visit
|
14.02 g/m2/h
Standard Deviation 5.12
|
14.57 g/m2/h
Standard Deviation 6.03
|
|
Change in TEWL at Mid-point Outer Lower Legs
Left leg TEWL at 1st visit
|
15.46 g/m2/h
Standard Deviation 6.07
|
14.55 g/m2/h
Standard Deviation 5.12
|
|
Change in TEWL at Mid-point Outer Lower Legs
Right leg TEWL at 4th visit
|
9.87 g/m2/h
Standard Deviation 2.86
|
8.22 g/m2/h
Standard Deviation 2.27
|
|
Change in TEWL at Mid-point Outer Lower Legs
Left leg TEWL at 4th visit
|
10.34 g/m2/h
Standard Deviation 3.27
|
8.61 g/m2/h
Standard Deviation 2.43
|
PRIMARY outcome
Timeframe: Change from baseline following 3 months of interventionPopulation: 3 month post-intervention data was missing from one male participant in control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.
Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the outer lower leg 8cms above the external malleolus. A reduction in TEWL indicates a positive effect on skin barrier function.It is generally recommended that differences or percentage changes are reported rather than absolute values. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.
Outcome measures
| Measure |
Control Group
n=193 Legs
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
Experimental Group
n=190 Legs
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
|---|---|---|
|
Change in TEWL at Base of Outer Lower Legs
Right leg TEWL at 1st visit
|
16.45 g/m2/h
Standard Deviation 6.13
|
16.80 g/m2/h
Standard Deviation 6.79
|
|
Change in TEWL at Base of Outer Lower Legs
Left leg TEWL at 1st visit
|
17.32 g/m2/h
Standard Deviation 5.46
|
17.02 g/m2/h
Standard Deviation 5.98
|
|
Change in TEWL at Base of Outer Lower Legs
Right leg TEWL at 4th visit
|
11.50 g/m2/h
Standard Deviation 3.35
|
9.30 g/m2/h
Standard Deviation 2.56
|
|
Change in TEWL at Base of Outer Lower Legs
Left leg TEWL at 4th visit
|
11.87 g/m2/h
Standard Deviation 3.59
|
9.88 g/m2/h
Standard Deviation 2.27
|
PRIMARY outcome
Timeframe: Change from baseline following 3 months of interventionPopulation: 3 month post intervention data missing from one male participant in control group. One left foot leg in the control group and one right and one left foot in the experimental group was not affected by podoconiosis so they were not included in the study.
Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the top of the foot. A reduction in TEWL indicates a positive effect on skin barrier function.It is generally recommended that differences or percentage changes are reported rather than absolute values. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.
Outcome measures
| Measure |
Control Group
n=193 Feet
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
Experimental Group
n=190 Feet
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
|---|---|---|
|
Change in TEWL at Top of Feet
Right foot 1st visit
|
21.97 g/m2/h
Standard Deviation 5.46
|
22.88 g/m2/h
Standard Deviation 6.74
|
|
Change in TEWL at Top of Feet
Left foot 1st visit
|
23.01 g/m2/h
Standard Deviation 5.06
|
22.47 g/m2/h
Standard Deviation 6.79
|
|
Change in TEWL at Top of Feet
Right foot 4th visit
|
14.90 g/m2/h
Standard Deviation 4.36
|
13.15 g/m2/h
Standard Deviation 3.87
|
|
Change in TEWL at Top of Feet
Left foot 4th visit
|
15.38 g/m2/h
Standard Deviation 4.09
|
13.49 g/m2/h
Standard Deviation 3.77
|
PRIMARY outcome
Timeframe: Change from baseline following 3 months of interventionPopulation: 3 month post intervention data missing from one male participant in control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.
Stratum corneum hydration was measured at a specific point at top of outer lower leg (8cms below the head of the fibula) with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.
Outcome measures
| Measure |
Control Group
n=193 Legs
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
Experimental Group
n=190 Legs
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
|---|---|---|
|
Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs
Right leg SCH 1st visit
|
9.60 Arbitrary units
Standard Deviation 3.96
|
9.05 Arbitrary units
Standard Deviation 3.98
|
|
Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs
Left leg SCH 1st visit
|
9.82 Arbitrary units
Standard Deviation 4.54
|
9.25 Arbitrary units
Standard Deviation 4.09
|
|
Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs
Right leg SCH 4th visit
|
13.73 Arbitrary units
Standard Deviation 3.59
|
16.24 Arbitrary units
Standard Deviation 3.72
|
|
Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs
Left leg SCH 4th visit
|
15.30 Arbitrary units
Standard Deviation 11.19
|
16.10 Arbitrary units
Standard Deviation 4.15
|
PRIMARY outcome
Timeframe: Change from baseline following 3 months of interventionPopulation: 3 month post intervention data missing from one male participant in the control group.One left leg in the control group and one right and one left leg in the experimental group were not affected by podoconiosis so they were not included in the study.
SCH was measured mid-way between the measurement site at the top of the outer leg and the site at the base of the outer lower leg. It was measured with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.
Outcome measures
| Measure |
Control Group
n=193 Legs
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
Experimental Group
n=190 Legs
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
|---|---|---|
|
Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg.
Right leg SCH at 1st visit
|
9.20 Arbitrary units
Standard Deviation 3.29
|
8.86 Arbitrary units
Standard Deviation 4.08
|
|
Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg.
Left leg SCH at 1st visit
|
9.39 Arbitrary units
Standard Deviation 3.83
|
9.05 Arbitrary units
Standard Deviation 3.78
|
|
Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg.
Right leg SCH at 4th visit
|
13.88 Arbitrary units
Standard Deviation 2.78
|
15.90 Arbitrary units
Standard Deviation 3.77
|
|
Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg.
Left leg SCH at 4th visit
|
14.56 Arbitrary units
Standard Deviation 3.90
|
15.95 Arbitrary units
Standard Deviation 3.19
|
PRIMARY outcome
Timeframe: Change from baseline following 3 months of interventionPopulation: 3 month data missing from one male participant in control group.One left leg in the control group and one right and one left leg in the experimental group were not affected by podoconiosis so they were not included in the study.
Stratum corneum hydration was measured at the base of the outer lower leg 8 cms above the external malleolus. It was measured with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.
Outcome measures
| Measure |
Control Group
n=193 Legs
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
Experimental Group
n=190 Legs
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
|---|---|---|
|
Change in Stratum Corneum Hydration at Base of Outer Lower Leg
Right leg SCH 1st visit
|
8.46 Arbitrary units
Standard Deviation 3.95
|
8.56 Arbitrary units
Standard Deviation 4.66
|
|
Change in Stratum Corneum Hydration at Base of Outer Lower Leg
Left leg SCH at 1st visit
|
8.26 Arbitrary units
Standard Deviation 4.01
|
8.85 Arbitrary units
Standard Deviation 4.36
|
|
Change in Stratum Corneum Hydration at Base of Outer Lower Leg
Right leg SCH 4th visit
|
14.25 Arbitrary units
Standard Deviation 3.84
|
15.93 Arbitrary units
Standard Deviation 3.80
|
|
Change in Stratum Corneum Hydration at Base of Outer Lower Leg
Left leg SCH 4th visit
|
14.47 Arbitrary units
Standard Deviation 4.41
|
16.47 Arbitrary units
Standard Deviation 3.40
|
PRIMARY outcome
Timeframe: Change from baseline following 3 months of interventionPopulation: 3 month post intervention data missing from one male participant in the control group. One left foot in the control group and one left and one right foot in the experimental group were not affected by podoconiosis so they were not included in the study.
Stratum corneum hydration measured at a specific point on the middle top of the foot with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.
Outcome measures
| Measure |
Control Group
n=193 Feet
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
Experimental Group
n=190 Feet
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
|---|---|---|
|
Change in Stratum Corneum Hydration at Top of Feet
Left leg SCH at 1st visit
|
8.39 Arbitrary units
Standard Deviation 5.97
|
8.87 Arbitrary units
Standard Deviation 6.72
|
|
Change in Stratum Corneum Hydration at Top of Feet
Right leg SCH at 4th visit
|
15.31 Arbitrary units
Standard Deviation 4.54
|
17.29 Arbitrary units
Standard Deviation 4.59
|
|
Change in Stratum Corneum Hydration at Top of Feet
Left leg SCH 4th visit
|
15.14 Arbitrary units
Standard Deviation 4.92
|
17.47 Arbitrary units
Standard Deviation 4.90
|
|
Change in Stratum Corneum Hydration at Top of Feet
Right leg SCH at 1st visit
|
8.48 Arbitrary units
Standard Deviation 5.52
|
8.50 Arbitrary units
Standard Deviation 6.30
|
SECONDARY outcome
Timeframe: Change from baseline following 3 months of interventionPopulation: 3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data were pre-specified to be collected and analysed for all participants as a single group.
Podoconiosis Staging System (1-5) used with 5 the most severe stage. This staging system was specifically designed for those with podoconiosis. Legs with stages 1, 2 or 3 were categorised with mild/moderate disease and those with stages 4,5 with severe disease.
Outcome measures
| Measure |
Control Group
n=383 Legs
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
Experimental Group
n=381 Legs
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
|---|---|---|
|
Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit
Left leg stage 5
|
14 Legs/feet
|
0 Legs/feet
|
|
Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit
Right leg stage nil
|
2 Legs/feet
|
2 Legs/feet
|
|
Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit
Left legs stage nil
|
1 Legs/feet
|
1 Legs/feet
|
|
Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit
Right legs stage 1
|
22 Legs/feet
|
56 Legs/feet
|
|
Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit
Left legs stage 1
|
20 Legs/feet
|
49 Legs/feet
|
|
Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit
Right leg stage 2
|
63 Legs/feet
|
50 Legs/feet
|
|
Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit
Left leg stage 2
|
66 Legs/feet
|
53 Legs/feet
|
|
Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit
Right leg stage 3
|
19 Legs/feet
|
64 Legs/feet
|
|
Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit
Left leg stage 3
|
17 Legs/feet
|
68 Legs/feet
|
|
Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit
Right leg stage 4
|
72 Legs/feet
|
29 Legs/feet
|
|
Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit
Left leg stage 4
|
75 Legs/feet
|
21 Legs/feet
|
|
Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit
Right leg stage 5
|
15 Legs/feet
|
0 Legs/feet
|
|
Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit
Right leg missing data
|
0 Legs/feet
|
1 Legs/feet
|
|
Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit
Left leg missing data
|
0 Legs/feet
|
1 Legs/feet
|
SECONDARY outcome
Timeframe: Change from baseline following 3 months of interventionPopulation: 3 month post intervention data missing from one male participant in the control group.One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data were pre-specified to be collected and analysed for all participants in a single group.
Total number of observed trophic changes (mossy eruptions on the skin of the lower legs/feet characteristic of podoconiosis) in all participants by clinic nurse at baseline and at 4th visit. Trophic changes were either present or not present.
Outcome measures
| Measure |
Control Group
n=193 Participants
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
Experimental Group
n=192 Participants
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
|---|---|---|
|
Total Number of Trophic Skin Changes (Mossy Changes) All Participants at Baseline and 4th Visit
|
312 Trophic skin changes
|
237 Trophic skin changes
|
SECONDARY outcome
Timeframe: Change from baseline following 3 months of interventionPopulation: 3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data were pre-specified to be collected and analysed for all participants in a single group.
Change in the presence of bad odour emanating from wounds on participant's lower legs/feet as determined by clinic nurse. Bad odour results in social stigma and impacts of quality of life.
Outcome measures
| Measure |
Control Group
n=193 Participants
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
Experimental Group
n=192 Participants
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
|---|---|---|
|
Total Number of All Participants With the Presence of a Bad Odour Emanating From Their Lower Limbs.
|
114 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Change from baseline following 3 months of interventionPopulation: 3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data was pre-specified to be analysed for all participants as a single group.
Observation and count of number of wounds (all breaches of the stratum corneum including areas of fungal infection) on lower legs/feet by clinic nurse. Breaches in the skin and areas of fungal infection are more likely to occur in those with an impaired skin barrier function.A reduction in the number of wounds indicates an improvement in SBF.
Outcome measures
| Measure |
Control Group
n=383 Feet/legs
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
Experimental Group
n=381 Feet/legs
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
|---|---|---|
|
Number of Wounds on Lower Legs/Feet of Participants.
|
962 Wounds
|
29 Wounds
|
SECONDARY outcome
Timeframe: Change from baseline following 3 months of interventionPopulation: 3 month post intervention data missing from one male participant in the control group.One leg in the control group and two legs in experimental group were not affected by podoconiosis.Data were pre-specified to be analysed for all participants as a single group.
Verbal questioning of participants by clinic nurse or social worker as to number of work days lost due to severe leg pain (adenolymphangitis). Questioning was used as most participants were illiterate.
Outcome measures
| Measure |
Control Group
n=193 Participants
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
Experimental Group
n=192 Participants
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
|---|---|---|
|
Change in Number of Work Days Lost in Previous Month Due to Adenolymphangitis (ADL)
|
868 Number of work days lost.
|
9 Number of work days lost.
|
SECONDARY outcome
Timeframe: From baseline monthly for 3 monthsPopulation: 3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis.Data were pre-specified to be collected and analysed for all participants in a single group.
Statistical calculation of the correlation between the number of work days lost in the previous month due to leg pain (adenolymphangitis) and the number of wounds present on the lower leg/foot. Wounds on the lower legs/feet may produce a bad odour.
Outcome measures
| Measure |
Control Group
n=193 Participants
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
Experimental Group
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
|---|---|---|
|
Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds
Correlation at baseline
|
0.252 Spearman's correlation coefficient
|
—
|
|
Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds
Correlation at 2nd visit
|
0.306 Spearman's correlation coefficient
|
—
|
|
Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds
Correlation at 3rd visit
|
0.291 Spearman's correlation coefficient
|
—
|
|
Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds
Correlation at 4th visit
|
0.265 Spearman's correlation coefficient
|
—
|
SECONDARY outcome
Timeframe: Change from baseline following 3 months of interventionPopulation: 3 month post intervention data missing from one male participant in the control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.
Measured by clinic nurse in centimetres with a disposable tape measure at the point of largest circumference on the foot.
Outcome measures
| Measure |
Control Group
n=193 Legs
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
Experimental Group
n=190 Legs
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
|---|---|---|
|
Change in Largest Lower Leg Circumference
|
-3.86 Centimetres
Standard Deviation 2.82
|
-4.14 Centimetres
Standard Deviation 1.74
|
SECONDARY outcome
Timeframe: Change from baseline following 3 months of interventionPopulation: 3 month post intervention data missing from one male participant in the control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.
Measured by clinic nurse in centimetres with a disposable tape measure at the point of largest circumference on the foot
Outcome measures
| Measure |
Control Group
n=193 Foot circumference
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
Experimental Group
n=190 Foot circumference
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
|---|---|---|
|
Change in Largest Foot Circumference
|
-2.34 Centimetres
Standard Deviation 2.73
|
-2.90 Centimetres
Standard Deviation 1.93
|
SECONDARY outcome
Timeframe: Change from baseline following 3 months of interventionPopulation: 3 month post intervention data missing from one male participant in the control group.
The Amharic version of the DLQI has been validated for use in Ethiopia where Amharic is the official working language. The index is divided into 4 sections covering leisure, work and school, personal relationships and treatment. The maximum score of 30 indicates a high impact on quality of life. The lowest score zero. A reduction in the number indicates an improvement in quality of life. Participants were verbally questioned by the clinic nurse or social worker as most participants were illiterate.
Outcome measures
| Measure |
Control Group
n=97 Participants
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
Experimental Group
n=96 Participants
Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
|
|---|---|---|
|
Amharic Dermatology Life Quality Index (DLQI)
DLQI at baseline
|
21.61 units on a scale
Standard Deviation 5.82
|
21.07 units on a scale
Standard Deviation 7.49
|
|
Amharic Dermatology Life Quality Index (DLQI)
DLQI 4th visit
|
4.12 units on a scale
Standard Deviation 4.29
|
3.94 units on a scale
Standard Deviation 3.82
|
Adverse Events
Control Group
Experimental Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place