Non-filarial ElephantiasisPhase 3NCT02839772

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

A Phase 3 study testing Current skin care regimen plus 2% glycerine added to soaking water and Current skin care regimen in people with Non-filarial Elephantiasis, run by University of Hull.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-filarial Elephantiasis
What is being tested?: Current skin care regimen plus 2% glycerine added to soaking water and Current skin care regimen
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 193 participants
Where: No sites listed yet
Study dates: Jan 2014to Aug 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

About this study

Official title: A Randomised Controlled Trial to Evaluate the Effect of a New Skin Care Regimen on Skin Barrier Function in Those With Podoconiosis in Ethiopia

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.

Conditions: Non-filarial Elephantiasis
Being tested: Current skin care regimen plus 2% glycerine added to soaking water, Current skin care regimen
Keywords: podoconiosis, glycerine, RCT, SBF, TEWL, SC hydration
Medical subject headings: Elephantiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Current skin care regimen plus 2% glycerine added to soaking waterOther
Also called glycerine
Current skin care regimenOther

Study groups in NCT02839772
Study group	Role	What they receive
Current skin care regimen	Active comparator	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (0.0125%), air dried, thin layer of petrolatum jelly applied and Whitfields ointment if required for any fungal infection. Receives: Other: Current skin care regimen
Current skin regimen plus 2% glycerine	Experimental	Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied and Whitfields ointment if required for any fungal infection. Receives: Other: Current skin care regimen plus 2% glycerine added to soaking water

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline following 3 months of intervention

Secondary outcomes (9)

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.
Measured: Change from baseline following 3 months of intervention
Total Number of Trophic Skin Changes (Mossy Changes) All Participants at Baseline and 4th Visit
Total number of observed trophic changes (mossy eruptions on the skin of the lower legs/feet characteristic of podoconiosis) in all participants by clinic nurse at baseline and at 4th visit. Trophic changes were either present or not present.
Measured: Change from baseline following 3 months of intervention
Total Number of All Participants With the Presence of a Bad Odour Emanating From Their Lower Limbs.
Change in the presence of bad odour emanating from wounds on participant's lower legs/feet as determined by clinic nurse. Bad odour results in social stigma and impacts of quality of life.
Measured: Change from baseline following 3 months of intervention
Number of Wounds on Lower Legs/Feet of Participants.
Observation and count of number of wounds (all breaches of the stratum corneum including areas of fungal infection) on lower legs/feet by clinic nurse.
Breaches in the skin and areas of fungal infection are more likely to occur in those with an impaired skin barrier function.A reduction in the number of wounds indicates an improvement in SBF.
Measured: Change from baseline following 3 months of intervention
Change in Number of Work Days Lost in Previous Month Due to Adenolymphangitis (ADL)
Verbal questioning of participants by clinic nurse or social worker as to number of work days lost due to severe leg pain (adenolymphangitis). Questioning was used as most participants were illiterate.
Measured: Change from baseline following 3 months of intervention
Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds
Statistical calculation of the correlation between the number of work days lost in the previous month due to leg pain (adenolymphangitis) and the number of wounds present on the lower leg/foot. Wounds on the lower legs/feet may produce a bad odour.
Measured: From baseline monthly for 3 months
Change in Largest Lower Leg Circumference
Measured by clinic nurse in centimetres with a disposable tape measure at the point of largest circumference on the foot.
Measured: Change from baseline following 3 months of intervention
Change in Largest Foot Circumference
Measured by clinic nurse in centimetres with a disposable tape measure at the point of largest circumference on the foot
Measured: Change from baseline following 3 months of intervention
Amharic Dermatology Life Quality Index (DLQI)
The Amharic version of the DLQI has been validated for use in Ethiopia where Amharic is the official working language. The index is divided into 4 sections covering leisure, work and school, personal relationships and treatment. The maximum score of 30 indicates a high impact on quality of life. The lowest score zero. A reduction in the number indicates an improvement in quality of life. Participants were verbally questioned by the clinic nurse or social worker as most participants were illiterate.
Measured: Change from baseline following 3 months of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Aug 2014

First posted21 Jul 2016 (estimated)
Study startJan 2014
Primary completionAug 2014
Study completionAug 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-filarial ElephantiasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 193 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02839772
Sponsor's protocol ID: UHull
Status last verified: Aug 2016
First submitted: 12 Jul 2016
Last updated: 6 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised Controlled Trial to Evaluate the Effect of a New Skin Care Regimen on Skin Barrier Function in Those With Podoconiosis in Ethiopia
ClinicalTrials.gov ID: NCT02839772
Acronym / sponsor ID: UHull
Conditions: Non-filarial Elephantiasis
Keywords: podoconiosis, glycerine, RCT, SBF, TEWL, SC hydration
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 193 participants (actual)
Lead sponsor: University of HullUniversity, hospital or other
Collaborators: Procter and Gamble
Study start: Jan 2014
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 21 Jul 2016 (estimated)
Results: Posted 6 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Current skin care regimen	Active comparator	Other: Current skin care regimenLegs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (0.0125%), air dried, thin layer of petrolatum jelly applied and Whitfields ointment if required for any fungal infection.
Current skin regimen plus 2% glycerine	Experimental	Other: Current skin care regimen plus 2% glycerine added to soaking waterLegs/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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Current skin care regimen plus 2% glycerine added to soaking waterAlso: glycerine	Other	Current skin regimen plus 2% glycerine
Current skin care regimen	Other	Current skin care regimen

Primary outcome

Change in TEWL at Top of Outer Lower Legs
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.

9 secondary outcomes

Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit
Time frame: Change from baseline following 3 months of intervention
Total Number of Trophic Skin Changes (Mossy Changes) All Participants at Baseline and 4th Visit
Time frame: 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.
Time frame: Change from baseline following 3 months of intervention
Number of Wounds on Lower Legs/Feet of Participants.
Time frame: Change from baseline following 3 months of intervention
Change in Number of Work Days Lost in Previous Month Due to Adenolymphangitis (ADL)
Time frame: Change from baseline following 3 months of intervention
Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds
Time frame: From baseline monthly for 3 months
Change in Largest Lower Leg Circumference
Time frame: Change from baseline following 3 months of intervention
Change in Largest Foot Circumference
Time frame: Change from baseline following 3 months of intervention
Amharic Dermatology Life Quality Index (DLQI)
Time frame: Change from baseline following 3 months of intervention

Results and safety

Results posted to the registry on 6 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Current Skin Care Regimen	97	96
Current Skin Regimen Plus 2% Glycerine	96	96

Primary outcome: Change in TEWL at Top of Outer Lower Legs

Time frame: Change from baseline following 3 months of intervention. Mean (Standard Deviation). Unit: g/m2/h

Measure	Control Group n = 97	Experimental Group n = 96
Right leg TEWL at 1st visit	12.74 (4.73)	13.43 (5.56)
Left leg TEWL at 1st visit	13.52 (5.61)	13.27 (4.91)
Right leg TEWL at 4th visit	8.76 (2.63)	7.06 (1.96)
Left leg TEWL at 4th visit	9.09 (2.63)	7.53 (2.12)

Control Group vs Experimental Group: Mean Difference (Final Values): 1.581 (95% CI 0.997 to 2.164), p <0.001, Mixed Models Analysis

Population analysed: 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.

Primary outcome: Change in TEWL at Mid-point Outer Lower Legs

Time frame: Change from baseline following 3 months of intervention. Mean (Standard Deviation). Unit: g/m2/h

Measure	Control Group n = 97	Experimental Group n = 96
Right leg TEWL at 1st visit	14.02 (5.12)	14.57 (6.03)
Left leg TEWL at 1st visit	15.46 (6.07)	14.55 (5.12)
Right leg TEWL at 4th visit	9.87 (2.86)	8.22 (2.27)
Left leg TEWL at 4th visit	10.34 (3.27)	8.61 (2.43)

Control Group vs Experimental Group: Mean Difference (Final Values): 1.684 (95% CI 1.002 to 2.367), p <0.001, Mixed Models Analysis

Population analysed: 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.

Primary outcome: Change in TEWL at Base of Outer Lower Legs

Time frame: Change from baseline following 3 months of intervention. Mean (Standard Deviation). Unit: g/m2/h

Measure	Control Group n = 97	Experimental Group n = 96
Right leg TEWL at 1st visit	16.45 (6.13)	16.80 (6.79)
Left leg TEWL at 1st visit	17.32 (5.46)	17.02 (5.98)
Right leg TEWL at 4th visit	11.50 (3.35)	9.30 (2.56)
Left leg TEWL at 4th visit	11.87 (3.59)	9.88 (2.27)

Control Group vs Experimental Group: Mean Difference (Final Values): 1.970 (95% CI 1.210 to 2.731), p <0.001, Mixed Models Analysis

Population analysed: 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.

Primary outcome: Change in TEWL at Top of Feet

Time frame: Change from baseline following 3 months of intervention. Mean (Standard Deviation). Unit: g/m2/h

Measure	Control Group n = 97	Experimental Group n = 96
Right foot 1st visit	21.97 (5.46)	22.88 (6.74)
Left foot 1st visit	23.01 (5.06)	22.47 (6.79)
Right foot 4th visit	14.90 (4.36)	13.15 (3.87)
Left foot 4th visit	15.38 (4.09)	13.49 (3.77)

Control Group vs Experimental Group: Mean Difference (Final Values): 1.751 (95% CI 0.656 to 2.846), p = 0.002, Mixed Models Analysis

Population analysed: 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.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group	0 of 97 (0%)	0 of 97 (0%)	Not reported
Experimental Group	0 of 96 (0%)	0 of 96 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Current skin care regimen plus 2% glycerine added to soaking water and Current skin care regimen in people with Non-filarial Elephantiasis, run by University of Hull.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in TEWL at Top of Outer Lower Legs (time frame: Change from baseline following 3 months of intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02839772.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2017.