Treatment of leg ulcers using placenta derived collagen biofabric

Abstract

The present invention provides a method of treating a leg ulcer comprising contacting the leg ulcer with a collagen biofabric. The leg ulcer may be a venous, arterial, diabetic or decubitus (pressure) ulcer. The invention further provides kits comprising one or more pieces of collagen biofabric for the treatment of a leg ulcer.

1 .- 24 . (canceled) 
     
     
         25 . A sterilized, decellularized, and dehydrated amnion-derived biofabric, wherein said biofabric is coated with or impregnated with granulocyte macrophage stimulating factor (GM-CSF). 
     
     
         26 . The biofabric of  claim 25 , wherein said biofabric comprises native vascular-endothelial growth factor (VEGF) and fibroblast growth factor (FGF). 
     
     
         27 . A pharmaceutical composition comprising the biofabric of  claim 25 . 
     
     
         28 . A pharmaceutical composition comprising the biofabric of  claim 26 . 
     
     
         29 . The biofabric of  claim 25 , wherein said biofabric is shaped as a sheet or membrane. 
     
     
         30 . The biofabric of  claim 29 , wherein said biofabric is shaped as a sheet. 
     
     
         31 . The biofabric of  claim 25 , wherein said biofabric is shaped as a netting or webbing. 
     
     
         32 . The biofabric of  claim 25 , wherein said biofabric is mounted on a support. 
     
     
         33 . The biofabric of  claim 32 , wherein said support is a bandage. 
     
     
         34 . A method of treating a leg ulcer, comprising contacting said ulcer with the collagen biofabric of  claim 25 . 
     
     
         35 . The method of  claim 34 , wherein said contacting improves at least one aspect of the leg ulcer, or prevents or reduces the worsening of at least one aspect of a leg ulcer. 
     
     
         36 . The method of  claim 34 , wherein said contacting is for a time sufficient for at least one aspect of the leg ulcer to measurably improve compared to a leg ulcer not contacted with the collagen biofabric. 
     
     
         37 . The method of  claim 34 , wherein said contacting is for a time sufficient to prevent or reduce the worsening of at least one aspect of said leg ulcer. 
     
     
         38 . The method of  claim 34 , wherein said leg ulcer is a venous leg ulcer, arterial leg ulcer, diabetic leg ulcer, or decubitus ulcer. 
     
     
         39 . The method of  claim 38 , wherein said leg ulcer is a venous leg ulcer. 
     
     
         40 . The method of  claim 34 , wherein said contacting comprises placing the collagen biofabric on the leg ulcer so that substantially all of the surface area of the biofabric contacts the leg ulcer. 
     
     
         41 . A kit for the facilitation of the treatment of leg ulcers, comprising the collagen biofabric of  claim 25 . 
     
     
         42 . The kit of  claim 41 , further comprising a medical device, disposable or drug that facilitates treatment of a leg ulcer. 
     
     
         43 . The kit of  claim 41 , wherein the collagen biofabric is provided as a single sheet or patch in a sterile container or wrapping. 
     
     
         44 . The kit of  claim 41 , further comprising an anti-infective agent and/or a wound healing agent.