System and method for treating leg ulcers

Abstract

In one aspect, a wound treatment system includes an inner layer comprising a foam material impregnated with a zinc oxide containing composition with or without calamine and/or ichthammol and in the presence or absence of antimicrobial agent (inorganic and/or organic). An optional outer layer comprises a short/long stretch compression bandage. In another aspect, a method of manufacturing the foam article impregnated with the zinc oxide containing composition is disclosed. In yet another aspect, a method of applying the wound treatment system to a patient's leg is disclosed. In still another aspect, a kit is provided including a foam layer impregnated with a zinc oxide containing composition; optionally, an elastic bandage component (e.g., long or short stretch elastic bandage); and, optionally, an outer stocking or sleeve, wherein the bandage system components are packaged together.

What is claimed is: 
     
         1 . A wound care device for the treatment of wounds on a limb of a subject, said device comprising:
 an inner, skin contacting layer formed of an elongate strip of a foam material, said foam material impregnated with a zinc oxide containing composition comprising zinc oxide in a pharmaceutically acceptable carrier.   
     
     
         2 . The device according to  claim 1 , further comprising a second, outer layer comprising an elastic compression bandage disposed over the first layer. 
     
     
         3 . The device according to  claim 1 , wherein said zinc oxide containing composition contains from about 5% to about 40% by weight of zinc oxide. 
     
     
         4 . The device according to  claim 1 , further comprising:
 said skin contacting layer having a thickness of between about 0.15 cm and about 0.45 cm.   
     
     
         5 . The device according to  claim 1 , wherein said foam material is formed of a polymeric foam material selected from polyurethane, polyester, polyester/polyurethane, and polyethylene. 
     
     
         6 . The device according to  claim 1 , wherein said zinc oxide containing composition contains up to about 10% by weight of calamine. 
     
     
         7 . The device according to  claim 1 , wherein said zinc oxide containing composition contains up to about 10% by weight of ichthammol. 
     
     
         8 . The device of  claim 1 , wherein said zinc oxide containing composition comprises zinc oxide, calamine, water, glycerin, gelatin, sorbitol, magnesium aluminum silicate, and Paraben-DU. 
     
     
         9 . The device of  claim 1 , wherein said zinc oxide containing composition further comprises an additive selected from: one or more organic antimicrobial agents, one or more inorganic antimicrobial agents, one or more anti-odor agents, one or more anti-inflammatory agents, one or more pain relieving agents, one or more antibiotics, and any combination thereof. 
     
     
         10 . The device of  claim 1 , wherein said inner layer is stretchable to provide a compressive force when stretched and wrapped about the limb of the patient. 
     
     
         11 . The device of  claim 2 , wherein said outer layer stretchable to provide a compressive force when stretched and wrapped about the limb of the patient. 
     
     
         12 . The device of  claim 11 , wherein said outer layer has an unstretched length and a maximum stretched length, wherein the maximum stretched length is about 40-80% greater than the unstretched length. 
     
     
         13 . The device of  claim 2 , wherein said outer layer is a cohesive elastic bandage. 
     
     
         14 . The device of  claim 1 , further comprising:
 a sleeve adapted to be worn over said inner layer.   
     
     
         15 . The device of  claim 2 , further comprising:
 a sleeve adapted to be worn over said outer layer.   
     
     
         16 . A method for treating a skin ulcer in a limb of a subject in need thereof, said method comprising the steps of:
 circumferentially wrapping an inner, skin-contacting layer around the limb, the inner layer directly contacting the limb, the inner layer characterized by an elongate sheet of a foam material impregnated with a zinc oxide containing composition.   
     
     
         17 . The method of  claim 16 , further comprising:
 circumferentially wrapping a separate outer, elastic, compression bandage layer around the limb over the inner layer.   
     
     
         18 . The method according to  claim 16 , wherein said zinc oxide containing composition contains from about 5% to about 40% by weight of zinc oxide. 
     
     
         19 . The method according to  claim 16 , wherein said skin contacting layer has a thickness of between about 0.15 cm and about 0.45 cm. 
     
     
         20 . The method according to  claim 16 , wherein said foam material is formed of a polymeric foam material selected from polyurethane, polyester, polyester/polyurethane, and polyethylene. 
     
     
         21 . The method according to  claim 16 , wherein said zinc oxide containing composition contains up to about 10% by weight of calamine. 
     
     
         22 . The method according to  claim 16 , wherein said zinc oxide containing composition contains up to about 10% by weight of ichthammol. 
     
     
         23 . The method of  claim 16 , wherein said zinc oxide containing composition comprises zinc oxide, calamine, water, glycerin, gelatin, sorbitol, magnesium aluminum silicate, and Paraben-DU. 
     
     
         24 . The method of  claim 16 , wherein said zinc oxide containing composition further comprises an additive selected from one or more organic antimicrobial agents, one or more inorganic antimicrobial agents, one or more anti-odor agents, one or more anti-inflammatory agents, one or more pain relieving agents, one or more antibiotics, or any combination thereof. 
     
     
         25 . The method of  claim 16 , wherein said inner layer stretchable to provide a compressive force when stretched and wrapped about the limb of the patient. 
     
     
         26 . The method of  claim 17 , wherein said outer layer stretchable to provide a compressive force when stretched and wrapped about the limb of the patient. 
     
     
         27 . The method of  claim 26 , wherein said outer layer has an unstretched length and a maximum stretched length, wherein the maximum stretched length is about 40-80% greater than the unstretched length. 
     
     
         28 . The method of  claim 17 , wherein said outer layer is a cohesive elastic bandage. 
     
     
         29 . The method of  claim 17 , further comprising:
 applying a third layer over said compression bandage layer, said third layer selected from a stocking and a sleeve.   
     
     
         30 . A kit having component parts packaged together, said kit comprising:
 a first, skin-contacting layer, said inner layer characterized by an elongate, strip of a foam material impregnated with a zinc oxide containing composition; and   a second layer comprising an elastic, compression bandage.   
     
     
         31 . The kit of  claim 29 , further comprising:
 a third layer selected from a stocking and a sleeve, the third layer adapted to be received over the second layer.