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CompletedNCT02839772Updated Jan 6, 2017Results posted

An RCT to Evaluate the Effect of a New Skin Care Regimen on SBF in Those With Podoconiosis

A Phase 3 interventional study of Current skin care regimen plus 2% glycerine added to soaking water and Current skin care regimen in Non-filarial Elephantiasis, sponsored by University of Hull. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-06.

Sponsored by University of Hull · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
193
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Non-filarial Elephantiasis

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Keywords

  • podoconiosis
  • glycerine
  • RCT
  • SBF
  • TEWL
  • SC hydration
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
193 participants (actual)

Study arms

  • Active comparator
    Current skin care regimen

    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.

    Other: Current skin care regimen

  • Experimental
    Current skin regimen plus 2% glycerine

    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.

    Other: Current skin care regimen plus 2% glycerine added to soaking water

Interventions

  • OtherCurrent skin care regimen plus 2% glycerine added to soaking water

    Also known as: glycerine

  • OtherCurrent skin care regimen
05

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

06

Results

Posted Jan 6, 2017
Limitations and caveats
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.

Participant flow

Participant flow — Overall Study
MilestoneCurrent Skin Care RegimenCurrent Skin Regimen Plus 2% Glycerine
Started9796
Completed9696
Not completed10

Outcome measures

PrimaryChange 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
Reported as:
Mean · g/m2/h
Change in TEWL at Top of Outer Lower Legs
g/m2/hControl GroupExperimental Group
Right leg TEWL at 1st visit12.74 ± 4.7313.43 ± 5.56
Left leg TEWL at 1st visit13.52 ± 5.6113.27 ± 4.91
Right leg TEWL at 4th visit8.76 ± 2.637.06 ± 1.96
Left leg TEWL at 4th visit9.09 ± 2.637.53 ± 2.12
Statistical analysis
  • Control Group vs Experimental Group · Mixed Models Analysis · p = <0.001 · Mean difference (final values): 1.581 · 95% CI 0.997 to 2.164t=5.341, df=89.347
PrimaryChange 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
Reported as:
Mean · g/m2/h
Change in TEWL at Mid-point Outer Lower Legs
g/m2/hControl GroupExperimental Group
Right leg TEWL at 1st visit14.02 ± 5.1214.57 ± 6.03
Left leg TEWL at 1st visit15.46 ± 6.0714.55 ± 5.12
Right leg TEWL at 4th visit9.87 ± 2.868.22 ± 2.27
Left leg TEWL at 4th visit10.34 ± 3.278.61 ± 2.43
Statistical analysis
  • Control Group vs Experimental Group · Mixed Models Analysis · p = <0.001 · Mean difference (final values): 1.684 · 95% CI 1.002 to 2.367t=4.871, df=189.789
PrimaryChange 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
Reported as:
Mean · g/m2/h
Change in TEWL at Base of Outer Lower Legs
g/m2/hControl GroupExperimental Group
Right leg TEWL at 1st visit16.45 ± 6.1316.80 ± 6.79
Left leg TEWL at 1st visit17.32 ± 5.4617.02 ± 5.98
Right leg TEWL at 4th visit11.50 ± 3.359.30 ± 2.56
Left leg TEWL at 4th visit11.87 ± 3.599.88 ± 2.27
Statistical analysis
  • Control Group vs Experimental Group · Mixed Models Analysis · p = <0.001 · Mean difference (final values): 1.970 · 95% CI 1.210 to 2.731t=5.111, df=189.620
PrimaryChange 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
Reported as:
Mean · g/m2/h
Change in TEWL at Top of Feet
g/m2/hControl GroupExperimental Group
Right foot 1st visit21.97 ± 5.4622.88 ± 6.74
Left foot 1st visit23.01 ± 5.0622.47 ± 6.79
Right foot 4th visit14.90 ± 4.3613.15 ± 3.87
Left foot 4th visit15.38 ± 4.0913.49 ± 3.77
Statistical analysis
  • Control Group vs Experimental Group · Mixed Models Analysis · p = 0.002 · Mean difference (final values): 1.751 · 95% CI 0.656 to 2.846t=3.154, df=189.580
PrimaryChange 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
Reported as:
Mean · Arbitrary units
Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs
Arbitrary unitsControl GroupExperimental Group
Right leg SCH 1st visit9.60 ± 3.969.05 ± 3.98
Left leg SCH 1st visit9.82 ± 4.549.25 ± 4.09
Right leg SCH 4th visit13.73 ± 3.5916.24 ± 3.72
Left leg SCH 4th visit15.30 ± 11.1916.10 ± 4.15
Statistical analysis
  • Control Group vs Experimental Group · Mixed Models Analysis · p = <0.001 · Mean difference (final values): -2.075 · 95% CI -3.042 to -1.1078t=-4.236,df=165.310
PrimaryChange 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
Reported as:
Mean · Arbitrary units
Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg.
Arbitrary unitsControl GroupExperimental Group
Right leg SCH at 1st visit9.20 ± 3.298.86 ± 4.08
Left leg SCH at 1st visit9.39 ± 3.839.05 ± 3.78
Right leg SCH at 4th visit13.88 ± 2.7815.90 ± 3.77
Left leg SCH at 4th visit14.56 ± 3.9015.95 ± 3.19
Statistical analysis
  • Control Group vs Experimental Group · Mixed Models Analysis · p = <0.001 · Mean difference (final values): -1.658 · 95% CI -2.581 to -0.736t=-3.549, df=180.923
PrimaryChange 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
Reported as:
Mean · Arbitrary units
Change in Stratum Corneum Hydration at Base of Outer Lower Leg
Arbitrary unitsControl GroupExperimental Group
Right leg SCH 1st visit8.46 ± 3.958.56 ± 4.66
Left leg SCH at 1st visit8.26 ± 4.018.85 ± 4.36
Right leg SCH 4th visit14.25 ± 3.8415.93 ± 3.80
Left leg SCH 4th visit14.47 ± 4.4116.47 ± 3.40
Statistical analysis
  • Control Group vs Experimental Group · Mixed Models Analysis · p = 0.001 · Mean difference (final values): -1.641 · 95% CI -2.574 to -0.708t=-3.471, df=186.308
PrimaryChange 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
Reported as:
Mean · Arbitrary units
Change in Stratum Corneum Hydration at Top of Feet
Arbitrary unitsControl GroupExperimental Group
Right leg SCH at 1st visit8.48 ± 5.528.50 ± 6.30
Left leg SCH at 1st visit8.39 ± 5.978.87 ± 6.72
Right leg SCH at 4th visit15.31 ± 4.5417.29 ± 4.59
Left leg SCH 4th visit15.14 ± 4.9217.47 ± 4.90
Statistical analysis
  • Control Group vs Experimental Group · Mixed Models Analysis · p = <0.001 · Mean difference (final values): -2.041 · 95% CI -3.168 to -0.911t=-3.565, df=186.739
SecondaryStage 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
Reported as:
Number · Legs/feet
Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit
Legs/feetStage of Podoconiosis 1st VisitStage of Podoconiosis 4th Visit
Right leg stage nil22
Left legs stage nil11
Right legs stage 12256
Left legs stage 12049
Right leg stage 26350
Left leg stage 26653
Right leg stage 31964
Left leg stage 31768
Right leg stage 47229
Left leg stage 47521
Right leg stage 5150
Left leg stage 5140
Right leg missing data01
Left leg missing data01
Statistical analysis
  • Stage of Podoconiosis 1st Visit vs Stage of Podoconiosis 4th Visit · Generalized estimating equation analysis · p = 0.076 (A cumulative logistic link function was used) · Odds ratio, log: 0.452 · 95% CI -0.048 to 0.952Wald Chi squared=3.138, df=1
SecondaryTotal 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
Reported as:
Number · Trophic skin changes
Total Number of Trophic Skin Changes (Mossy Changes) All Participants at Baseline and 4th Visit
Trophic skin changesTotal Number of Trophic Skin Changes at BaselineTotal Number of Trophic Skin Changes at 4th Visit
Total Number of Trophic Skin Changes (Mossy Changes) All Participants at Baseline and 4th Visit312237
Statistical analysis
  • Total Number of Trophic Skin Changes at Baseline vs Total Number of Trophic Skin Changes at 4th Visit · Generalized estimating equation analysis · p = 0.527 (A Bernouilli distribution with a logistic link function was used.) · Odds ratio, log: -0.224 · 95% CI -0.469 to 0.917Wald chi-square=0.410, df=1
SecondaryTotal 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
Reported as:
Number · Participants
Total Number of All Participants With the Presence of a Bad Odour Emanating From Their Lower Limbs.
ParticipantsParticipants With Bad Odour From Legs/Feet at BaselineParticipants With Bad Odour From Legs/Feet at 4th Visit
Total Number of All Participants With the Presence of a Bad Odour Emanating From Their Lower Limbs.1143
Statistical analysis
  • Participants With Bad Odour From Legs/Feet at Baseline vs Participants With Bad Odour From Legs/Feet at 4th Visit · Generalized estimating equation analysis · p = 0.031 (A Bernouilli distribution with a logistic link function was used) · Odds ratio, log: -1.29 · 95% CI -2.161 to -0.411Wald chi-square=8.304, df=1
SecondaryNumber 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
Reported as:
Number · Wounds
Number of Wounds on Lower Legs/Feet of Participants.
WoundsNumber of Wounds at BaselineNumber of Wounds 4th Visit
Number of Wounds on Lower Legs/Feet of Participants.96229
Statistical analysis
  • Number of Wounds at Baseline vs Number of Wounds 4th Visit · Generalized estimating equation analysis · p = 0.005 (A Poisson distribution with a logarithmic link function was used) · Odds ratio, log: 2.062 · 95% CI 0.610 to 3.514Wald chi-square=7.745, df=1
SecondaryChange 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
Reported as:
Number · Number of work days lost.
Change in Number of Work Days Lost in Previous Month Due to Adenolymphangitis (ADL)
Number of work days lost.Number of Days Work Days Lost by All Participants BaselineNumber of Days Lost by All Participants at 4th Visit
Change in Number of Work Days Lost in Previous Month Due to Adenolymphangitis (ADL)8689
Statistical analysis
  • Number of Days Work Days Lost by All Participants Baseline · Generalized estimation equation · p = 0.058 (A Poisson distribution with a logarithmic link function was used.) · Group ratio estimate: 2.090 · 0.058% CI -0.069 to 4.250Those in the experimental group were expected to have fewer work days lost due to ADL.
SecondaryCorrelation 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
Reported as:
Number · Spearman's correlation coefficient
Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds
Spearman's correlation coefficientCorrelation Between Number of Wounds and Days Lost Due to ADL
Correlation at baseline0.252
Correlation at 2nd visit0.306
Correlation at 3rd visit0.291
Correlation at 4th visit0.265
Statistical analysis
  • Correlation Between Number of Wounds and Days Lost Due to ADL · Spearman's correlation coefficient · p = <0.001 (The p value was \< 0.001 at all time points.)The correlation at the 1st visit was 0.252, at the 2nd 0.306, at the 3rd 0.291 and at the 4th 0.265.
SecondaryChange 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
Reported as:
Mean · Centimetres
Change in Largest Lower Leg Circumference
CentimetresControl GroupExperimental Group
Change in Largest Lower Leg Circumference-3.86 ± 2.82-4.14 ± 1.74
Statistical analysis
  • Control Group vs Experimental Group · Mixed Models Analysis · p = 0.158 · Median difference (final values): 0.288 · 95% CI -0.113 to 0.690df=185.386
SecondaryChange 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
Reported as:
Mean · Centimetres
Change in Largest Foot Circumference
CentimetresControl GroupExperimental Group
Change in Largest Foot Circumference-2.34 ± 2.73-2.90 ± 1.93
Statistical analysis
  • Control Group vs Experimental Group · Mixed Models Analysis · p = <0.001 · Mean difference (final values): 0.575 · 95% CI 0.255 to 0.895df=169.916, t=3.550
SecondaryAmharic 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
Reported as:
Mean · units on a scale
Amharic Dermatology Life Quality Index (DLQI)
units on a scaleControl GroupExperimental Group
DLQI at baseline21.61 ± 5.8221.07 ± 7.49
DLQI 4th visit4.12 ± 4.293.94 ± 3.82
Statistical analysis
  • Control Group vs Experimental Group · Mixed Models Analysis · p = 0.907 · Mean difference (final values): -0.063 · 95% CI -1.129 to 1.002t=-0.117, df=178.814

Adverse events

Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control Group—0/97 (0%)0/97 (0%)
Experimental Group—0/96 (0%)0/96 (0%)

Baseline characteristics

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

Age, Categorical
Age, Categorical(Participants)Current Skin Care RegimenCurrent Skin Regimen Plus 2% GlycerineTotal
<=18 years000
Between 18 and 65 years8482166
>=65 years131427
Gender
Gender(Participants)Current Skin Care RegimenCurrent Skin Regimen Plus 2% GlycerineTotal
Female494998
Male484795
Region of Enrollment
Region of Enrollment(participants)Current Skin Care RegimenCurrent Skin Regimen Plus 2% GlycerineTotal
Ethiopia9796193
Severity of podoconioisis based on a staging systeme
Severity of podoconioisis based on a staging systeme(participants)Current Skin Care RegimenCurrent Skin Regimen Plus 2% GlycerineTotal
Less severe/moderate disease474693
Severe disease5050100
07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Registry details

Key details

Study ID
NCT02839772
Lead sponsor
University of Hull
Collaborators
Procter and Gamble
Responsible party
Jill Brooks (PhD student, University of Hull) — Principal investigator
First posted
Jul 21, 2016
Start date
Jan 2014
Primary completion
Aug 2014
Completion
Aug 2014
Results posted
Jan 6, 2017
Last update
Jan 6, 2017

Study contacts

Jill Brooks, PhD student
principal investigator · University of Hull, UK
Steven J Ersser, PhD,
study director · University of Leeds, UK
Fiona C Cowdell, DProf,
study director · University of Hull, UK
Eric Gardiner, PhD,
study director · University of Hull, UK
Paul J Matts, PhD
study director · Procter and Gamble

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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