Non-filarial Elephantiasis
Conditions
Keywords
podoconiosis, glycerine, RCT, SBF, TEWL, SC hydration
Brief summary
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.
Detailed description
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.
Interventions
OTHERCurrent skin care regimen plus 2% glycerine added to soaking water
OTHERCurrent skin care regimen
Sponsors
Procter and Gamble
University of Hull
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients in Ethiopia with a diagnosis of podoconiosis. That is those living above 1000 feet sea level with high rainfall, above 1,00mm annually with foot or lower leg oedema which had started in the feet, with sensation present in the feet and no hand involvement. The diagnosis was determined by the nurses at the outreach clinics. * Patients who were able to understand instructions and give informed consent as determined by the nurses at the outreach clinics. * Patients over 18 years of age.
Exclusion criteria
* Patients not diagnosed with podoconiosis as determined by nurses at the outreach clinics. * Patients who were unable to understand instructions or give informed consent as determined by nurses at the outreach clinics. * Patients under 18 years of age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in TEWL at Top of Outer Lower Legs | Change from baseline following 3 months of intervention | 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 in TEWL at Mid-point Outer Lower Legs | Change from baseline following 3 months of intervention | 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 in TEWL at Base of Outer Lower Legs | Change from baseline following 3 months of intervention | 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 in TEWL at Top of Feet | Change from baseline following 3 months of intervention | 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. |
| Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs | Change from baseline following 3 months of intervention | 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 in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg. | Change from baseline following 3 months of intervention | 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 in Stratum Corneum Hydration at Base of Outer Lower Leg | Change from baseline following 3 months of intervention | 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 in Stratum Corneum Hydration at Top of Feet | Change from baseline following 3 months of intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Change from baseline following 3 months of intervention | 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 in Largest Foot Circumference | Change from baseline following 3 months of intervention | Measured by clinic nurse in centimetres with a disposable tape measure at the point of largest circumference on the foot |
| Total Number of Trophic Skin Changes (Mossy Changes) All Participants at Baseline and 4th Visit | Change from baseline following 3 months of intervention | 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. |
| Total Number of All Participants With the Presence of a Bad Odour Emanating From Their Lower Limbs. | Change from baseline following 3 months of intervention | 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. |
| Number of Wounds on Lower Legs/Feet of Participants. | Change from baseline following 3 months of intervention | 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. |
| Amharic Dermatology Life Quality Index (DLQI) | Change from baseline following 3 months of intervention | 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 in Number of Work Days Lost in Previous Month Due to Adenolymphangitis (ADL) | Change from baseline following 3 months of intervention | 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. |
| Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds | From baseline monthly for 3 months | 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. |
| Change in Largest Lower Leg Circumference | Change from baseline following 3 months of intervention | Measured by clinic nurse in centimetres with a disposable tape measure at the point of largest circumference on the foot. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 97 |
| 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. | 96 |
| Total | 193 |
Baseline characteristics
| Characteristic | Current Skin Care Regimen | Current Skin Regimen Plus 2% Glycerine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 14 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 84 Participants | 82 Participants | 166 Participants |
| Gender Female | 49 Participants | 49 Participants | 98 Participants |
| Gender Male | 48 Participants | 47 Participants | 95 Participants |
| Region of Enrollment Ethiopia | 97 participants | 96 participants | 193 participants |
| Severity of podoconioisis based on a staging systeme Less severe/moderate disease | 47 participants | 46 participants | 93 participants |
| Severity of podoconioisis based on a staging systeme Severe disease | 50 participants | 50 participants | 100 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 97 | 0 / 96 |
| serious Total, serious adverse events | 0 / 97 | 0 / 96 |
Outcome results
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.
Time frame: Change from baseline following 3 months of intervention
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Change in Stratum Corneum Hydration at Base of Outer Lower Leg | Right leg SCH 1st visit | 8.46 Arbitrary units | Standard Deviation 3.95 |
| Control Group | 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 |
| Control Group | Change in Stratum Corneum Hydration at Base of Outer Lower Leg | Right leg SCH 4th visit | 14.25 Arbitrary units | Standard Deviation 3.84 |
| Control Group | Change in Stratum Corneum Hydration at Base of Outer Lower Leg | Left leg SCH 4th visit | 14.47 Arbitrary units | Standard Deviation 4.41 |
| Experimental Group | Change in Stratum Corneum Hydration at Base of Outer Lower Leg | Left leg SCH 4th visit | 16.47 Arbitrary units | Standard Deviation 3.4 |
| Experimental Group | Change in Stratum Corneum Hydration at Base of Outer Lower Leg | Right leg SCH 1st visit | 8.56 Arbitrary units | Standard Deviation 4.66 |
| Experimental Group | Change in Stratum Corneum Hydration at Base of Outer Lower Leg | Right leg SCH 4th visit | 15.93 Arbitrary units | Standard Deviation 3.8 |
| Experimental Group | Change in Stratum Corneum Hydration at Base of Outer Lower Leg | Left leg SCH at 1st visit | 8.85 Arbitrary units | Standard Deviation 4.36 |
Comparison: The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the base of the outer lower legs by group from baseline after 3 months of interventions.p-value: 0.00195% CI: [-2.574, -0.708]Mixed Models Analysis
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.
Time frame: Change from baseline following 3 months of intervention
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Change in Stratum Corneum Hydration at Top of Feet | Right leg SCH at 1st visit | 8.48 Arbitrary units | Standard Deviation 5.52 |
| Control Group | Change in Stratum Corneum Hydration at Top of Feet | Right leg SCH at 4th visit | 15.31 Arbitrary units | Standard Deviation 4.54 |
| Control Group | Change in Stratum Corneum Hydration at Top of Feet | Left leg SCH at 1st visit | 8.39 Arbitrary units | Standard Deviation 5.97 |
| Control Group | Change in Stratum Corneum Hydration at Top of Feet | Left leg SCH 4th visit | 15.14 Arbitrary units | Standard Deviation 4.92 |
| Experimental Group | Change in Stratum Corneum Hydration at Top of Feet | Left leg SCH at 1st visit | 8.87 Arbitrary units | Standard Deviation 6.72 |
| Experimental Group | Change in Stratum Corneum Hydration at Top of Feet | Right leg SCH at 1st visit | 8.50 Arbitrary units | Standard Deviation 6.3 |
| Experimental Group | Change in Stratum Corneum Hydration at Top of Feet | Left leg SCH 4th visit | 17.47 Arbitrary units | Standard Deviation 4.9 |
| Experimental Group | Change in Stratum Corneum Hydration at Top of Feet | Right leg SCH at 4th visit | 17.29 Arbitrary units | Standard Deviation 4.59 |
Comparison: The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the base of the top of the feet by group from baseline after 3 months of interventions.p-value: <0.00195% CI: [-3.168, -0.911]Mixed Models Analysis
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.
Time frame: Change from baseline following 3 months of intervention
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | 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 |
| Control Group | 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 |
| Control Group | 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 |
| Control Group | Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg. | Left leg SCH at 4th visit | 14.56 Arbitrary units | Standard Deviation 3.9 |
| Experimental Group | Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg. | Left leg SCH at 4th visit | 15.95 Arbitrary units | Standard Deviation 3.19 |
| Experimental Group | Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg. | Right leg SCH at 1st visit | 8.86 Arbitrary units | Standard Deviation 4.08 |
| Experimental Group | Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg. | Right leg SCH at 4th visit | 15.90 Arbitrary units | Standard Deviation 3.77 |
| Experimental Group | Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg. | Left leg SCH at 1st visit | 9.05 Arbitrary units | Standard Deviation 3.78 |
Comparison: The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the mid-point of the outer lower legs by group from baseline after 3 months of interventions.p-value: <0.00195% CI: [-2.581, -0.736]Mixed Models Analysis
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.
Time frame: Change from baseline following 3 months of intervention
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | 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 |
| Control Group | 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 |
| Control Group | 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 |
| Control Group | 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 |
| Experimental Group | Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs | Left leg SCH 4th visit | 16.10 Arbitrary units | Standard Deviation 4.15 |
| Experimental Group | Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs | Right leg SCH 1st visit | 9.05 Arbitrary units | Standard Deviation 3.98 |
| Experimental Group | Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs | Right leg SCH 4th visit | 16.24 Arbitrary units | Standard Deviation 3.72 |
| Experimental Group | Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs | Left leg SCH 1st visit | 9.25 Arbitrary units | Standard Deviation 4.09 |
Comparison: The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the top of the outer lower legs by group from baseline after 3 months of interventions.p-value: <0.00195% CI: [-3.042, -1.1078]Mixed Models Analysis
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.
Time frame: Change from baseline following 3 months of intervention
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Change in TEWL at Base of Outer Lower Legs | Right leg TEWL at 1st visit | 16.45 g/m2/h | Standard Deviation 6.13 |
| Control Group | Change in TEWL at Base of Outer Lower Legs | Left leg TEWL at 1st visit | 17.32 g/m2/h | Standard Deviation 5.46 |
| Control Group | Change in TEWL at Base of Outer Lower Legs | Right leg TEWL at 4th visit | 11.50 g/m2/h | Standard Deviation 3.35 |
| Control Group | Change in TEWL at Base of Outer Lower Legs | Left leg TEWL at 4th visit | 11.87 g/m2/h | Standard Deviation 3.59 |
| Experimental Group | Change in TEWL at Base of Outer Lower Legs | Left leg TEWL at 4th visit | 9.88 g/m2/h | Standard Deviation 2.27 |
| Experimental Group | Change in TEWL at Base of Outer Lower Legs | Right leg TEWL at 1st visit | 16.80 g/m2/h | Standard Deviation 6.79 |
| Experimental Group | Change in TEWL at Base of Outer Lower Legs | Right leg TEWL at 4th visit | 9.30 g/m2/h | Standard Deviation 2.56 |
| Experimental Group | Change in TEWL at Base of Outer Lower Legs | Left leg TEWL at 1st visit | 17.02 g/m2/h | Standard Deviation 5.98 |
Comparison: The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the base of the outer lower legs by group from baseline after 3 months of interventions.p-value: <0.00195% CI: [1.21, 2.731]Mixed Models Analysis
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.
Time frame: Change from baseline following 3 months of intervention
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Change in TEWL at Mid-point Outer Lower Legs | Right leg TEWL at 1st visit | 14.02 g/m2/h | Standard Deviation 5.12 |
| Control Group | Change in TEWL at Mid-point Outer Lower Legs | Left leg TEWL at 1st visit | 15.46 g/m2/h | Standard Deviation 6.07 |
| Control Group | Change in TEWL at Mid-point Outer Lower Legs | Right leg TEWL at 4th visit | 9.87 g/m2/h | Standard Deviation 2.86 |
| Control Group | Change in TEWL at Mid-point Outer Lower Legs | Left leg TEWL at 4th visit | 10.34 g/m2/h | Standard Deviation 3.27 |
| Experimental Group | Change in TEWL at Mid-point Outer Lower Legs | Left leg TEWL at 4th visit | 8.61 g/m2/h | Standard Deviation 2.43 |
| Experimental Group | Change in TEWL at Mid-point Outer Lower Legs | Right leg TEWL at 1st visit | 14.57 g/m2/h | Standard Deviation 6.03 |
| Experimental Group | Change in TEWL at Mid-point Outer Lower Legs | Right leg TEWL at 4th visit | 8.22 g/m2/h | Standard Deviation 2.27 |
| Experimental Group | Change in TEWL at Mid-point Outer Lower Legs | Left leg TEWL at 1st visit | 14.55 g/m2/h | Standard Deviation 5.12 |
Comparison: The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the mid-point of the outer lower legs by group from baseline after 3 months of interventions.p-value: <0.00195% CI: [1.002, 2.367]Mixed Models Analysis
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.
Time frame: Change from baseline following 3 months of intervention
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Change in TEWL at Top of Feet | Right foot 1st visit | 21.97 g/m2/h | Standard Deviation 5.46 |
| Control Group | Change in TEWL at Top of Feet | Left foot 1st visit | 23.01 g/m2/h | Standard Deviation 5.06 |
| Control Group | Change in TEWL at Top of Feet | Right foot 4th visit | 14.90 g/m2/h | Standard Deviation 4.36 |
| Control Group | Change in TEWL at Top of Feet | Left foot 4th visit | 15.38 g/m2/h | Standard Deviation 4.09 |
| Experimental Group | Change in TEWL at Top of Feet | Left foot 4th visit | 13.49 g/m2/h | Standard Deviation 3.77 |
| Experimental Group | Change in TEWL at Top of Feet | Right foot 1st visit | 22.88 g/m2/h | Standard Deviation 6.74 |
| Experimental Group | Change in TEWL at Top of Feet | Right foot 4th visit | 13.15 g/m2/h | Standard Deviation 3.87 |
| Experimental Group | Change in TEWL at Top of Feet | Left foot 1st visit | 22.47 g/m2/h | Standard Deviation 6.79 |
Comparison: The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the top of the feet by group from baseline after 3 months of interventions.p-value: 0.00295% CI: [0.656, 2.846]Mixed Models Analysis
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.
Time frame: Change from baseline following 3 months of intervention
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Change in TEWL at Top of Outer Lower Legs | Right leg TEWL at 1st visit | 12.74 g/m2/h | Standard Deviation 4.73 |
| Control Group | Change in TEWL at Top of Outer Lower Legs | Left leg TEWL at 1st visit | 13.52 g/m2/h | Standard Deviation 5.61 |
| Control Group | Change in TEWL at Top of Outer Lower Legs | Right leg TEWL at 4th visit | 8.76 g/m2/h | Standard Deviation 2.63 |
| Control Group | Change in TEWL at Top of Outer Lower Legs | Left leg TEWL at 4th visit | 9.09 g/m2/h | Standard Deviation 2.63 |
| Experimental Group | Change in TEWL at Top of Outer Lower Legs | Left leg TEWL at 4th visit | 7.53 g/m2/h | Standard Deviation 2.12 |
| Experimental Group | Change in TEWL at Top of Outer Lower Legs | Right leg TEWL at 1st visit | 13.43 g/m2/h | Standard Deviation 5.56 |
| Experimental Group | Change in TEWL at Top of Outer Lower Legs | Right leg TEWL at 4th visit | 7.06 g/m2/h | Standard Deviation 1.96 |
| Experimental Group | Change in TEWL at Top of Outer Lower Legs | Left leg TEWL at 1st visit | 13.27 g/m2/h | Standard Deviation 4.91 |
Comparison: The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function (SBF) in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the top of the outer lower legs by group from baseline after 3 months of interventions.p-value: <0.00195% CI: [0.997, 2.164]Mixed Models Analysis
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.
Time frame: Change from baseline following 3 months of intervention
Population: 3 month post intervention data missing from one male participant in the control group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Amharic Dermatology Life Quality Index (DLQI) | DLQI at baseline | 21.61 units on a scale | Standard Deviation 5.82 |
| Control Group | Amharic Dermatology Life Quality Index (DLQI) | DLQI 4th visit | 4.12 units on a scale | Standard Deviation 4.29 |
| Experimental Group | Amharic Dermatology Life Quality Index (DLQI) | DLQI at baseline | 21.07 units on a scale | Standard Deviation 7.49 |
| Experimental Group | Amharic Dermatology Life Quality Index (DLQI) | DLQI 4th visit | 3.94 units on a scale | Standard Deviation 3.82 |
Comparison: The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Podoconiosis has a large effect on a person's quality of life. abnormal looking legs/feet, wounds and the related bad odour plus social isolation result in stigma and social isolation..p-value: 0.90795% CI: [-1.129, 1.002]Mixed Models Analysis
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
Time frame: Change from baseline following 3 months of intervention
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change in Largest Foot Circumference | -2.34 Centimetres | Standard Deviation 2.73 |
| Experimental Group | Change in Largest Foot Circumference | -2.90 Centimetres | Standard Deviation 1.93 |
Comparison: The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~A reduction in foot circumference indicates an improvement in the disease.p-value: <0.00195% CI: [0.255, 0.895]Mixed Models Analysis
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.
Time frame: Change from baseline following 3 months of intervention
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change in Largest Lower Leg Circumference | -3.86 Centimetres | Standard Deviation 2.82 |
| Experimental Group | Change in Largest Lower Leg Circumference | -4.14 Centimetres | Standard Deviation 1.74 |
Comparison: The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~A reduction in leg circumference indicates an improvement in the disease.p-value: 0.15895% CI: [-0.113, 0.69]Mixed Models Analysis
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.
Time frame: Change from baseline following 3 months of intervention
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Change in Number of Work Days Lost in Previous Month Due to Adenolymphangitis (ADL) | 868 Number of work days lost. |
| Experimental Group | Change in Number of Work Days Lost in Previous Month Due to Adenolymphangitis (ADL) | 9 Number of work days lost. |
Comparison: The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds by group of having had fewer work days lost in the previous month at the 4th visit due to ADL.p-value: 0.0580.058% CI: [-0.069, 4.25]Generalized estimation equation
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.
Time frame: From baseline monthly for 3 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds | Correlation at 4th visit | 0.265 Spearman's correlation coefficient |
| Control Group | Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds | Correlation at baseline | 0.252 Spearman's correlation coefficient |
| Control Group | Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds | Correlation at 2nd visit | 0.306 Spearman's correlation coefficient |
| Control Group | Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds | Correlation at 3rd visit | 0.291 Spearman's correlation coefficient |
Comparison: The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.p-value: <0.001Spearman's correlation coefficient
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.
Time frame: Change from baseline following 3 months of intervention
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Number of Wounds on Lower Legs/Feet of Participants. | 962 Wounds |
| Experimental Group | Number of Wounds on Lower Legs/Feet of Participants. | 29 Wounds |
Comparison: The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of wounds being present on the lower legs/feet of participants by group at the 4th visit.p-value: 0.00595% CI: [0.61, 3.514]Generalized estimating equation analysis
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.
Time frame: Change from baseline following 3 months of intervention
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Right leg stage nil | 2 Legs/feet |
| Control Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Left legs stage nil | 1 Legs/feet |
| Control Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Right legs stage 1 | 22 Legs/feet |
| Control Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Left legs stage 1 | 20 Legs/feet |
| Control Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Right leg stage 2 | 63 Legs/feet |
| Control Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Left leg stage 2 | 66 Legs/feet |
| Control Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Right leg stage 3 | 19 Legs/feet |
| Control Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Left leg stage 3 | 17 Legs/feet |
| Control Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Right leg stage 4 | 72 Legs/feet |
| Control Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Left leg stage 4 | 75 Legs/feet |
| Control Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Right leg stage 5 | 15 Legs/feet |
| Control Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Left leg stage 5 | 14 Legs/feet |
| Control Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Right leg missing data | 0 Legs/feet |
| Control Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Left leg missing data | 0 Legs/feet |
| Experimental Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Right leg stage 5 | 0 Legs/feet |
| Experimental Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Right leg stage nil | 2 Legs/feet |
| Experimental Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Left leg stage 3 | 68 Legs/feet |
| Experimental Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Left legs stage nil | 1 Legs/feet |
| Experimental Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Right leg missing data | 1 Legs/feet |
| Experimental Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Right legs stage 1 | 56 Legs/feet |
| Experimental Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Right leg stage 4 | 29 Legs/feet |
| Experimental Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Left legs stage 1 | 49 Legs/feet |
| Experimental Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Left leg stage 5 | 0 Legs/feet |
| Experimental Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Right leg stage 2 | 50 Legs/feet |
| Experimental Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Left leg stage 4 | 21 Legs/feet |
| Experimental Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Left leg stage 2 | 53 Legs/feet |
| Experimental Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Left leg missing data | 1 Legs/feet |
| Experimental Group | Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit | Right leg stage 3 | 64 Legs/feet |
Comparison: The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of the stage of podoconiosis by group being more severe at the 4th visit.p-value: 0.07695% CI: [-0.048, 0.952]Generalized estimating equation analysis
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.
Time frame: Change from baseline following 3 months of intervention
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Total Number of All Participants With the Presence of a Bad Odour Emanating From Their Lower Limbs. | 114 Participants |
| Experimental Group | Total Number of All Participants With the Presence of a Bad Odour Emanating From Their Lower Limbs. | 3 Participants |
Comparison: The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of participants having a bad odour emanating from their lower legs/feet by group at the 4th visit. Bad odour results in a decease in quality of life.p-value: 0.03195% CI: [-2.161, -0.411]Generalized estimating equation analysis
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.
Time frame: Change from baseline following 3 months of intervention
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Total Number of Trophic Skin Changes (Mossy Changes) All Participants at Baseline and 4th Visit | 312 Trophic skin changes |
| Experimental Group | Total Number of Trophic Skin Changes (Mossy Changes) All Participants at Baseline and 4th Visit | 237 Trophic skin changes |
Comparison: The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of mossy changes being present in the lower legs/feet by group at the 4th visit.p-value: 0.52795% CI: [-0.469, 0.917]Generalized estimating equation analysis