An RCT to Evaluate the Effect of a New Skin Care Regimen on SBF in Those With Podoconiosis (NCT02839772) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in TEWL at Top of Outer Lower Legs
Timeframe: Change from baseline following 3 months of intervention
2
Change in TEWL at Mid-point Outer Lower Legs
Timeframe: Change from baseline following 3 months of intervention
3
Change in TEWL at Base of Outer Lower Legs
Timeframe: Change from baseline following 3 months of intervention
4
Change in TEWL at Top of Feet
Timeframe: Change from baseline following 3 months of intervention
5
Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs
Timeframe: Change from baseline following 3 months of intervention
6
Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg.
Timeframe: Change from baseline following 3 months of intervention
7
Change in Stratum Corneum Hydration at Base of Outer Lower Leg