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Unable to recruit suitable subjects within a reasonable time period.
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The purpose of this study is to evaluate the efficacy of a special sock, manufactured using TEPSO®, compared to a normal cotton sock in the prognosis of symmetrical palmoplantar pustulosis present for at least one year.
The clinical manifestations of palmoplantar pustulosis have an important impact on well being and quality of life. The manifestation of the disease is often exacerbated by factors such as significant physical and mechanical stress resulting from repeated and prolonged pressure over the affected areas and by everyday clothing. These problems have led the textile industry Lenzi Egisto S.p.A. to conduct some preliminary analyses to find a fabric that meets the specific needs of psoriatic patients in relation to everyday clothing. This preliminary study led to the creation of a particular fabric, TEPSO®, with features specific to the identified needs. This material consists essentially of PTFE (commercially known as Teflon®) and thus presents interesting characteristics that make it suitable for creating garments for patients with psoriasis:
We can therefore speculate that in palmoplantar pustulosis high smoothness of the fabric and low coefficient of friction may translate into less discomfort felt by patients during normal physical activities, and into improved clinical course of the disease. In the end, it is expected that reduced mechanical compression and friction, would result into partial or complete clinical remission within a few weeks of use.
Therefore we propose to conduct a randomized controlled, double-blind, left-right clinical trial to assess the hypothesis that in palmoplantar pustulosis the use of TEPSO® could induce an improvement of disease and overall quality of life. To better assess the effects of treatment, the use of clothing in the study will be limited to symmetrical pustular lesions of feet in order to include areas that are comparable and relevant from a functional point of view.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEPSO socks | Experimental | This arm include all patients sides (left or right) treated with TEPSO socks. |
|
| Standard socks | Placebo Comparator | This arm include all patients sides (left or right) treated with standard cotton socks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEPSO cloth | Device | TEPSO stocks should be worn continuously for 4 weeks of the study and will be changed every 3 days without wearing again those already used (even after washing). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage reduction of treated areas from baseline | Percentage reduction is based on standardized photos and computerized image evaluation | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Quality of life is assessed by patient with visual analogue scale (VAS) | 4 weeks |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luigi Naldi, dermatology | Centro Studi Gised | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, "Tor Vergata" general hospital | Rome | Lazio | 00133 | Italy | ||
| Department of Dermatology, Fondazione S.Raffaele del monte Tabor |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24434748 | Derived | Cazzaniga S, Lo Scocco G, Schincaglia E, Mercuri SR, Chimenti S, Saraceno R, Naldi L. Randomized, within-patient, clinical trial comparing fluorine-synthetic fiber socks with standard cotton socks in improving plantar pustulosis. Dermatology. 2014;228(2):166-71. doi: 10.1159/000357221. Epub 2014 Jan 9. |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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|
| Standard cloth | Device | Standard cotton stocks should be worn continuously for 4 weeks of the study and will be changed every 3 days without wearing again those already used (even after washing). |
|
|
| Milan |
| Lombardy |
| 20132 |
| Italy |
| Department of Dermatology, USL 4 | Prato | Tuscany | 59100 | Italy |