A Randomised Controlled Trial to Evaluate the Effect of a New Skin Care Regimen on Skin Barrier Function in Those With Podoconiosis in Ethiopia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 193
- 主要终点
- Change in TEWL at Top of Outer Lower Legs
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in TEWL at Top of Outer Lower Legs
时间窗: 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 Top of Feet
时间窗: 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 TEWL at Mid-point Outer Lower Legs
时间窗: 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
时间窗: 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 Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs
时间窗: 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.
时间窗: 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 Top of Feet
时间窗: 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.
Change in Stratum Corneum Hydration at Base of Outer Lower Leg
时间窗: 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.
次要结局
- 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)
- Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds(From baseline monthly for 3 months)
- Change in Largest Lower Leg Circumference(Change from baseline following 3 months of intervention)
- Change in Largest Foot Circumference(Change from baseline following 3 months of intervention)
- Amharic Dermatology Life Quality Index (DLQI)(Change from baseline following 3 months of intervention)
研究者
Jill Brooks
PhD student
University of Hull