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OXAID: Oxygenating Hydrogel for Diabetic Wound Care

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41DK105704-01A1
Agency Tracking Number: R41DK105704
Amount: $224,977.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 200
Solicitation Number: PA14-054
Solicitation Year: 2014
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-09-06
Award End Date (Contract End Date): 2019-08-31
Small Business Information
Akron, OH 44311-1051
United States
DUNS: 079300192
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (267) 231-8908
Business Contact
Phone: (267) 231-8908
Research Institution

DESCRIPTION provided by applicant Oxygen plays a significant role in wound healing and maintaining elevated tissue oxygenation levels are an important factor in the dermal healing response Specifically non healing diabetic chronic wounds defined as lasting andgt weeks often show devastatingly low oxygen concentrations as low as mmHg oxygen partial pressure In the USA there are more than million diabetics with million new cases every year About million new diabetic ulcers are diagnosed every year and these numbers are increasing as our population ages It is estimated that up to of all diabetics will develop a foot ulcer and a fifth of these cases will result in a chronic non healing wound that requires amputation Oxygen treatment has been demonstrated to promote chronic wound healing by enhancing metabolism extracellular matrix synthesis and neovascularization all while limiting antimicrobial activity Despite the benefits of supplemental oxygen current oxygen delivery therapies are intermittent inconvenient for the patient and require access to expensive and specialized equipment Hence there is a significant need for a simple low cost wound dressing able to support regenerative levels of oxygen and to supplement or possibly supplant current therapies hyperbaric oxygen topical oxygen via tent bag This proposal provides a unique polymerized chitosan hydrogel sheet dressing that has the potential to provide uniform and tunable oxygenation across an ulcerous chronic wound A biocompatible photocrosslinkable chitosan hydrogel covalently modified with perfluorocarbons PFCs has been invented The wound dressing made from the hydrogel will be marketed under the name OXAID tm through the company O RegenTech LLC OXAID uniquely allows for the creation of sheet hydrogels that covalently incorporate PFCs for sustained oxygenation for up to five days at significant oxygen partial pressures Thus OXAID potentially marries the benefits of oxygen treatment above with hydrogel dressings increased angiogenesis enhanced autolytic debridement increased re epithelialization The primary goal of this project is to obtain proof that OXAID is safe and can deliver oxygen to effectively heal chronic wounds The primary hypothesis is that the oxygen loaded fluorinated hydrogel platform will provide both enhanced dermal healing responses significantly faster and more completely than both unoxygenated controls and a commercial sheet hydrogel dressing To test this overall hypothesis the Specific Aims are Scale up OXAID synthesis and characterize chemical and material properties and Conduct a pre clinical in vivo feasibility study to evaluate the safety and efficacy of OXAID for diabetic chroni wound healing

PUBLIC HEALTH RELEVANCE Each year there are close to million incidences of chronic diabetic foot ulcers which generate more than $ billion in healthcare related costs and $ billion in both direct and indirect costs The medical field needs inexpensive effective treatments that can deliver faster and more powerful results Our product OXAID tm is an oxygenated hydrogel sheet dressing that combines the powerful healing benefits of high cost hyperbaric oxygen treatments with the low cost application of common synthetic dressings to effectively eliminate chronic diabetic foot ulcers

* Information listed above is at the time of submission. *

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