TREATMENT OF LEG ULCERS USING PLACENTA DERIVED COLLAGEN BIOFABRIC
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 . A method of treating a leg ulcer, comprising contacting said ulcer with a collagen biofabric, 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.
2 . The method of claim 1 , wherein said collagen biofabric is not artificially crosslinked.
3 . The method of claim 1 , wherein said collagen biofabric is about 20% or less water by weight.
4 . The method of claim 1 , wherein said collagen biofabric is not protease-treated during production.
5 . The method of claim 1 , 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.
6 . The method of claim 1 , wherein said contacting is for a time sufficient to prevent or reduce the worsening of at least one aspect of a leg ulcer.
7 . The method of claim 1 , wherein said leg ulcer is a venous leg ulcer, arterial leg ulcer, diabetic leg ulcer or decubitus ulcer.
8 . The method of claim 1 , wherein said leg ulcer is a venous leg ulcer.
9 . The method of claim 1 , wherein said collagen biofabric is provided as a sheet or membrane.
10 . The method of claim 1 , wherein said collagen biofabric is provided as a netting or webbing.
11 . The method of claim 1 , wherein said collagen biofabric is mounted on a support.
12 . The method of claim 11 , wherein said support is a bandage.
13 . The method of claim 1 , 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.
14 . The method of claim 1 , wherein said collagen biofabric additionally comprises a bioactive compound not naturally-occurring in the collagen biofabric, or present in a different concentration than in collagen biofabric to which the bioactive compound has not been added.
15 . The method of claim 14 , wherein said bioactive compound is a small organic molecule, an antibiotic, pain medication, anti-inflammatory agent, cytokine, growth factor, enzyme inhibitor, kinase inhibitor, an anti-tumor agent, an anti-fungal agent, an anti-viral agent, an anti-infective agent, a wound sealant or a wound healing or sealing agent.
16 . The method of claim 15 , wherein said wound healing or sealing agent is platelet-derived growth factor (PDGF), transforming growth factor (TGF), thymosin, hyaluronic acid, fibrin, fibronectin or thrombin, or a combination thereof.
17 . A kit for the facilitation of the treatment of leg ulcers, comprising a piece of collagen biofabric.
18 . The kit of claim 17 further comprising a medical device, disposable or drug that facilitates treatment of a leg ulcer.
19 . The kit of claim 17 , wherein the piece of collagen biofabric is provided as a single sheet or patch in a sterile container or wrapping.
20 . The kit of claim 17 further comprising two or more pieces of collagen biofabric, separately wrapped or contained.
21 . The kit of claim 17 further comprising a support for the collagen biofabric.
22 . The kit of claim 17 further comprising an anti-infective agent.
23 . The kit of claim 17 , further comprising a wound healing agent.
24 . The kit of claim 17 , wherein said collagen biofabric is provided as a sheet in a sterile double-peel pouch.