Phase 3
Completed N=193
An RCT to Evaluate the Effect of a New Skin Care Regimen on SBF in Those With Podoconiosis
Non-filarial Elephantiasis
Source: ClinicalTrials.gov NCT02839772 ↗
Enrolled (actual)
193
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Change in TEWL at Top of Outer Lower Legs — 12.74; 13.43; 13.52; 13.27 g/m2/h — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in TEWL at Top of Outer Lower Legs |
12.74; 13.43; 13.52; 13.27; 8.76; 7.06 | <0.001 sig |
| PRIMARY Change in TEWL at Mid-point Outer Lower Legs |
14.02; 14.57; 15.46; 14.55; 9.87; 8.22 | <0.001 sig |
| PRIMARY Change in TEWL at Base of Outer Lower Legs |
16.45; 16.80; 17.32; 17.02; 11.50; 9.30 | <0.001 sig |
| PRIMARY Change in TEWL at Top of Feet |
21.97; 22.88; 23.01; 22.47; 14.90; 13.15 | 0.002 sig |
| PRIMARY Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs |
9.60; 9.05; 9.82; 9.25; 13.73; 16.24 | <0.001 sig |
| PRIMARY Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg. |
9.20; 8.86; 9.39; 9.05; 13.88; 15.90 | <0.001 sig |
| PRIMARY Change in Stratum Corneum Hydration at Base of Outer Lower Leg |
8.46; 8.56; 8.26; 8.85; 14.25; 15.93 | 0.001 sig |
| PRIMARY Change in Stratum Corneum Hydration at Top of Feet |
8.48; 8.50; 8.39; 8.87; 15.31; 17.29 | <0.001 sig |
| SECONDARY Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit |
2; 2; 1; 1; 22; 56 | 0.076 |
| SECONDARY Total Number of Trophic Skin Changes (Mossy Changes) All Participants at Baseline and 4th Visit |
312; 237 | 0.527 |
| SECONDARY Total Number of All Participants With the Presence of a Bad Odour Emanating From Their Lower Limbs. |
114; 3 | 0.031 sig |
| SECONDARY Number of Wounds on Lower Legs/Feet of Participants. |
962; 29 | 0.005 sig |
| SECONDARY Change in Number of Work Days Lost in Previous Month Due to Adenolymphangitis (ADL) |
868; 9 | 0.058 |
| SECONDARY Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds |
0.252; 0.306; 0.291; 0.265 | <0.001 sig |
| SECONDARY Change in Largest Lower Leg Circumference |
-3.86; -4.14 | 0.158 |
| SECONDARY Change in Largest Foot Circumference |
-2.34; -2.90 | <0.001 sig |
| SECONDARY Amharic Dermatology Life Quality Index (DLQI) |
21.61; 21.07; 4.12; 3.94 | 0.907 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02839772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.