Comparison Dry Foot Skin Between Diabetic and Non-diabetic Subjects and the Effects of Two Cosmetic Foot Care Products
Condition: Xerosis Cutis
Study type: Interventional

Summary: 
      The overall aims of this study are to compare the structure and function of dry to very dry
      and cracked foot skin between diabetic and nondiabetic subjects and to evaluate the effects
      of two cosmetic leave-on products on dry and fissured diabetic foot skin.

      Specific issues are:

      Are there any differences between the morphological and functional characteristics of dry to
      very dry and cracked skin foot between diabetic and nondiabetic subjects? What are the
      effects of a 4-week once daily application of an intensive care foot ointment (urea 10% foot
      ointment) or foot lotion (10% Urea foot lotion) on the skin barrier and on clinical signs of
      dryness and fissures?
    

Detailed description: 
      A long existing diabetes mellitus type II is often associated with a number of skin changes.
      Xerosis Cutis is the most common skin alteration. The risk of diabetics of developing a foot
      ulcer is estimated to be 15%. Very dry and cracked skin represents an additional risk factor,
      so that adequate skin care is a widely recommended intervention in diabetic patients. But
      there are only few studies investigating the skin barrier structure and function in diabetic
      patients. Available study results seem to suggest, that for instance sebum content, stratum
      corneum hydration, and pH are associated with Diabetes mellitus.

      The overall aims of this study are to compare the structure and function of dry to very dry
      and cracked foot skin between diabetic and nondiabetic subjects and to evaluate the effects
      of two cosmetic leave-on products on dry and fissured diabetic foot skin.

      Specific issues are:

      Are there any differences between the morphological and functional characteristics of dry to
      very dry and cracked skin foot between diabetic and nondiabetic subjects? What are the
      effects of a 4-week once daily application of an intensive care foot ointment (urea 10% foot
      ointment) or foot lotion (10% Urea foot lotion) on the skin barrier and on clinical signs of
      dryness and fissures?
    

Intervention name(s): 10% Urea foot lotion; 10% Urea foot ointment
Intervention type(s): Other; Other
Intervention description(s): During the course of the study participants cleanse one foot (previously randomized) once daily using the mild cleanser "Cetaphil® Restoraderm Body Wash" and apply the product "Excipial® U10 Lipolotion 10% Urea" once daily in the evening by themselves.; During the course of the study participants cleanse one foot (previously randomized) once daily using the mild cleanser "Cetaphil® Restoraderm Body Wash" and apply the product "Excipial® U10 ointment10% Urea" once daily in the evening by themselves.
Intervention MeSH terms: Carbamide Peroxide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Single Blind (Investigator) Non-Randomized 60 [Anticipated]
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Diabetes type II