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| Name | Class |
|---|---|
| Procter and Gamble | INDUSTRY |
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An RCT (n=193) in two podoconiosis clinics in Ethiopia to evaluate the effectiveness of a research based skin management regimen compared to the current regimen. The experimental group added 2% glycerine to the current skin care regimen and used 1 litre of water in the water soak compared to the 6 litres used in the current regimen.
Background. Podoconiosis (non-filarial elephantiasis) affects some of the poorest people in 20 countries in the world. In Ethiopia least 3 million people are affected with 17 million at risk. Irritant minerals (smectite, mica and quartz) from volcanic soil and pathogens enter skin breaches in the feet causing inflammation, lymphoedema and hyperkeratosis. Podoconiosis is preventable and treatable but is not curable. Current treatment consists of educating those with disease on its causes, prevention and treatment. Treatment taught in the Action on Podoconiosis (APA) Clinics consists of a daily hygiene regimen of washing the feet/legs with soap, soaking the feet and legs in water with sodium hypochlorite (NaOCI) (0.0125%) added as a disinfectant, air drying and the application of a thin layer of petrolatum jelly. Whitfields ointment (benzoic acid and salicylic acid) is applied to any fungal infections. Wearing shoes is encouraged but this does not offer complete protection against the alkaline soil.
Although the current treatment skin care regimen is effective there is no robust evidence on optimal skin care regimens to improve skin barrier function in this disease.
Objective. To evaluate the effectiveness of a new, low-cost, evidence-based skin care intervention to improve SBF in the lower limbs of those with podoconiosis.
Method. A randomized control trial (RCT) was conducted over 3 months in two APA Clinics (n=193). Intervention was 2% glycerine (v/v) added to a reduced amount of soaking water (1 litre versus 6 litres). The control group received the current skin care regimen. The primary outcome measure was skin barrier function (SBF). This was determined by measures of trans-epidermal water loss (TEWL) and stratum corneum hydration (SCH) at four specific sites on the lower limbs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Current skin care regimen | Active Comparator | Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (0.0125%), air dried, thin layer of petrolatum jelly applied and Whitfields ointment if required for any fungal infection. |
|
| Current skin regimen plus 2% glycerine | Experimental | Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied and Whitfields ointment if required for any fungal infection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Current skin care regimen plus 2% glycerine added to soaking water | Other |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in TEWL at Top of Outer Lower Legs | 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. | Change from baseline following 3 months of intervention |
| Change in TEWL at Mid-point Outer Lower Legs | 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. | Change from baseline following 3 months of intervention |
| Change in TEWL at Base of Outer Lower Legs | 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. | Change from baseline following 3 months of intervention |
| Change in TEWL at Top of Feet | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | 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. | Change from baseline following 3 months of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jill Brooks, PhD student | University of Hull, UK | Principal Investigator |
| Steven J Ersser, PhD, | University of Leeds, UK | Study Director |
| Fiona C Cowdell, DProf, | University of Hull, UK | Study Director |
| Eric Gardiner, PhD, | University of Hull, UK | Study Director |
| Paul J Matts, PhD | Procter and Gamble | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Clinic A. 47 with less severe/ moderate disease (stages 1,2,3) and 47 with severe disease (stages 4,5) Clinic B. 49 with less severe/ moderate disease and 50 with severe disease
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| ID | Title | Description |
|---|---|---|
| BG000 | Current Skin Care Regimen | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in TEWL at Top of Outer Lower Legs | 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. | 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. | Posted | Mean | Standard Deviation | g/m2/h | Change from baseline following 3 months of intervention | Legs | Legs |
|
3 months
Any adverse effects of the regimes on the skin of the lower legs/feet of all participants were noted by the clinic nurse.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | 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. |
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The study was not blinded which would have strengthened credibility and limited bias.The groups were matched but factors such as diet and co-morbidities particularly relating to blood flow in the legs/feet were not collected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jill Brooks. PhD student, | University of Hull | 01491 839044 | jb284@btinternet.com |
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| ID | Term |
|---|---|
| D004604 | Elephantiasis |
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D005990 | Glycerol |
| ID | Term |
|---|---|
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Current skin care regimen | Other |
|
| Change from baseline following 3 months of intervention |
| Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs | 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. | Change from baseline following 3 months of intervention |
| Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg. | 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. | Change from baseline following 3 months of intervention |
| Change in Stratum Corneum Hydration at Base of Outer Lower Leg | 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. | Change from baseline following 3 months of intervention |
| Change in Stratum Corneum Hydration at Top of Feet | 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. | Change from baseline following 3 months of intervention |
| Total Number of Trophic Skin Changes (Mossy Changes) All Participants at Baseline and 4th Visit | 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. | Change from baseline following 3 months of intervention |
| Total Number of All Participants With the Presence of a Bad Odour Emanating From Their Lower Limbs. | 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. | Change from baseline following 3 months of intervention |
| Number of Wounds on Lower Legs/Feet of Participants. | 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. | Change from baseline following 3 months of intervention |
| Change in Number of Work Days Lost in Previous Month Due to Adenolymphangitis (ADL) | 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. | Change from baseline following 3 months of intervention |
| Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds | 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. | From baseline monthly for 3 months |
| Change in Largest Lower Leg Circumference | Measured by clinic nurse in centimetres with a disposable tape measure at the point of largest circumference on the foot. | Change from baseline following 3 months of intervention |
| Change in Largest Foot Circumference | Measured by clinic nurse in centimetres with a disposable tape measure at the point of largest circumference on the foot | Change from baseline following 3 months of intervention |
| Amharic Dermatology Life Quality Index (DLQI) | 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. | Change from baseline following 3 months of intervention |
| Current Skin Regimen Plus 2% Glycerine |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Data was collected from new patients attending two Action on Podoconiosis Clinics in south-central Ethiopia with similar graphical features. Clinical practice at both was the same. | Number | participants |
|
| Severity of podoconioisis based on a staging systeme | There are 5 stages with 5 being the most severe stage of podoconiosis. | Number | participants |
|
| OG001 | 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. |
|
|
|
| Primary | Change in TEWL at Mid-point Outer Lower Legs | 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. | 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. | Posted | Mean | Standard Deviation | g/m2/h | Change from baseline following 3 months of intervention | Legs | Legs |
|
|
|
|
| Primary | Change in TEWL at Base of Outer Lower Legs | 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. | 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. | Posted | Mean | Standard Deviation | g/m2/h | Change from baseline following 3 months of intervention | Legs | Legs |
|
|
|
|
| Primary | Change in TEWL at Top of Feet | 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. | 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. | Posted | Mean | Standard Deviation | g/m2/h | Change from baseline following 3 months of intervention | Feet | Feet |
|
|
|
|
| Primary | Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs | 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. | 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. | Posted | Mean | Standard Deviation | Arbitrary units | Change from baseline following 3 months of intervention | Legs | Legs |
|
|
|
|
| Primary | Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg. | 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. | 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. | Posted | Mean | Standard Deviation | Arbitrary units | Change from baseline following 3 months of intervention | Legs | Legs |
|
|
|
|
| Primary | Change in Stratum Corneum Hydration at Base of Outer Lower Leg | 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. | 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. | Posted | Mean | Standard Deviation | Arbitrary units | Change from baseline following 3 months of intervention | Legs | Legs |
|
|
|
|
| Primary | Change in Stratum Corneum Hydration at Top of Feet | 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. | 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. | Posted | Mean | Standard Deviation | Arbitrary units | Change from baseline following 3 months of intervention | Feet | Feet |
|
|
|
|
| Secondary | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | 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. | 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. | Posted | Number | Legs/feet | Change from baseline following 3 months of intervention | Legs | Legs |
|
|
|
|
| Secondary | Total Number of Trophic Skin Changes (Mossy Changes) All Participants at Baseline and 4th Visit | 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. | 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. | Posted | Number | Trophic skin changes | Change from baseline following 3 months of intervention |
|
|
|
|
| Secondary | Total Number of All Participants With the Presence of a Bad Odour Emanating From Their Lower Limbs. | 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. | 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. | Posted | Number | Participants | Change from baseline following 3 months of intervention |
|
|
|
|
| Secondary | Number of Wounds on Lower Legs/Feet of Participants. | 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. | 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. | Posted | Number | Wounds | Change from baseline following 3 months of intervention | Feet/legs | Feet/legs |
|
|
|
|
| Secondary | Change in Number of Work Days Lost in Previous Month Due to Adenolymphangitis (ADL) | 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. | 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. | Posted | Number | Number of work days lost. | Change from baseline following 3 months of intervention |
|
|
|
|
| Secondary | Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds | 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. | 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. | Posted | Number | Spearman's correlation coefficient | From baseline monthly for 3 months |
|
|
|
|
| Secondary | Change in Largest Lower Leg Circumference | Measured by clinic nurse in centimetres with a disposable tape measure at the point of largest circumference on the foot. | 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. | Posted | Mean | Standard Deviation | Centimetres | Change from baseline following 3 months of intervention | Legs | Legs |
|
|
|
|
| Secondary | Change in Largest Foot Circumference | Measured by clinic nurse in centimetres with a disposable tape measure at the point of largest circumference on the foot | 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. | Posted | Mean | Standard Deviation | Centimetres | Change from baseline following 3 months of intervention | Foot circumference | Foot circumference |
|
|
|
|
| Secondary | Amharic Dermatology Life Quality Index (DLQI) | 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. | 3 month post intervention data missing from one male participant in the control group. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline following 3 months of intervention |
|
|
|
|
| 0 |
| 97 |
| 0 |
| 97 |
| EG001 | Experimental Group | 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. | 0 | 96 | 0 | 96 |
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Not provided
| D002241 |
| Carbohydrates |
| Right leg TEWL at 4th visit |
|
| Left leg TEWL at 4th visit |
|
| Right leg TEWL at 4th visit |
|
| Left leg TEWL at 4th visit |
|
| Right foot 4th visit |
|
| Left foot 4th visit |
|
| Right leg SCH 4th visit |
|
| Left leg SCH 4th visit |
|
| Right leg SCH at 4th visit |
|
| Left leg SCH at 4th visit |
|
| Right leg SCH 4th visit |
|
| Left leg SCH 4th visit |
|
| Right leg SCH at 4th visit |
|
| Left leg SCH 4th visit |
|
| Right legs stage 1 |
|
| Left legs stage 1 |
|
| Right leg stage 2 |
|
| Left leg stage 2 |
|
| Right leg stage 3 |
|
| Left leg stage 3 |
|
| Right leg stage 4 |
|
| Left leg stage 4 |
|
| Right leg stage 5 |
|
| Left leg stage 5 |
|
| Right leg missing data |
|
| Left leg missing data |
|
| Superiority or Other |
| Superiority or Other |
| No |
| Superiority or Other |
| No |
| Superiority or Other |
| No |
| Superiority or Other |
| Title | Measurements |
|---|---|
|
| Correlation at 4th visit |
|
| Superiority or Other |