CompletedPhase 3

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

193 participantsStarted 2014-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in TEWL at Top of Outer Lower Legs

Timeframe: Change from baseline following 3 months of intervention

Change in TEWL at Mid-point Outer Lower Legs

Timeframe: Change from baseline following 3 months of intervention

Change in TEWL at Base of Outer Lower Legs

Timeframe: Change from baseline following 3 months of intervention

Change in TEWL at Top of Feet

Timeframe: Change from baseline following 3 months of intervention

Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs

Timeframe: Change from baseline following 3 months of intervention

Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg.

Timeframe: Change from baseline following 3 months of intervention

Change in Stratum Corneum Hydration at Base of Outer Lower Leg

Timeframe: Change from baseline following 3 months of intervention

Trial details

NCT IDNCT02839772

SponsorUniversity of Hull

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-08

Results submitted2016-08-06

View on ClinicalTrials.gov More Non-filarial Elephantiasis trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in TEWL at Top of Outer Lower Legs

Timeframe: Change from baseline following 3 months of intervention

Change in TEWL at Mid-point Outer Lower Legs

Timeframe: Change from baseline following 3 months of intervention

Change in TEWL at Base of Outer Lower Legs

Timeframe: Change from baseline following 3 months of intervention

Change in TEWL at Top of Feet

Timeframe: Change from baseline following 3 months of intervention

Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs

Timeframe: Change from baseline following 3 months of intervention

Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg.

Timeframe: Change from baseline following 3 months of intervention

Change in Stratum Corneum Hydration at Base of Outer Lower Leg

Timeframe: Change from baseline following 3 months of intervention