Sponsor study identifier
interventional
193
0 countries
N/A
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2014
Actual (reported)Study Completion
August 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
August 2014
Actual (reported)August 2014
Actual (reported)July 12, 2016
Actual (reported)July 21, 2016
Actual (reported)January 6, 2017
Actual (reported)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.
Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit
Change from baseline following 3 months of intervention
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 All Participants With the Presence of a Bad Odour Emanating From Their Lower Limbs.
Change from baseline following 3 months of intervention
Number of Wounds on Lower Legs/Feet of Participants.
Change from baseline following 3 months of intervention
Change in Number of Work Days Lost in Previous Month Due to Adenolymphangitis (ADL)
Change from baseline following 3 months of intervention
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Jill Brooks, PhD student
University of Hull, UK
Steven J Ersser, PhD,
University of Leeds, UK
Fiona C Cowdell, DProf,
University of Hull, UK
Eric Gardiner, PhD,
University of Hull, UK
193 participants (actual enrollment reported by the registry).
First Submitted
July 12, 2016
First Posted
July 21, 2016
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
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.
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
Contact the study team to confirm eligibility.
Paul J Matts, PhD
Procter and Gamble
Primary Completion
August 2014
Actual (reported)Study Completion
August 2014
Actual (reported)Last Updated
January 6, 2017
Results First Posted
January 6, 2017
Record last verified: 2016-08
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Source: ClinicalTrials.gov.
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