Diabetic Foot Ulcer Healing by Load Relieving Dressings

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44DK062547-02
Agency Tracking Number: DK062547
Amount: $1,146,070.00
Phase: Phase II
Program: SBIR
Awards Year: 2005
Solicitation Year: 2005
Solicitation Topic Code: N/A
Solicitation Number: PHS2005-2
Small Business Information
Diapedia, Llc, 200 Innovation Blvd, Ste 240, State College, PA, 16803
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (814) 234-0700
Business Contact
Phone: (814) 234-0700
Research Institution
DESCRIPTION (provided by applicant): In the US more than 80,000 lower extremity amputations are performed in diabetic patients per year. Foot ulcers are much more common and the path to most amputations starts with an ulcer. The health care cost of these problems has been estimated to be almost $11 billion per year. The longer an ulcer stays open, the more likely it is to get infected and lead to an amputation. "Usual care" heals typically only about 30% of ulcers in 20 weeks, yet a total contact cast (TCC) can heal > 90% of ulcers in an average of 8 weeks. The main advantage of the TCC over other approaches is that it mechanically off-loads the wound and, since it cannot be removed by the patient, does so without need for patient compliance. Despite its significant superiority over "usual care" in terms of efficacy, acceptance of the TCC by providers is poor and thus efficacious alternatives must be found. Under the completed phase I SBIR we have demonstrated feasibility of a prototype Load Relieving Dressing (LRD) that also does not demand complete patient compliance. We have developed second generation prototypes which show off-loading equivalent to that of a TCC and we have begun testing in actual patients. We are also negotiating an agreement with a major dressing manufacturer which could lead to licensing of the final product. Under this phase II proposal we will refine the design of the LRD to facilitate its application to the wound site while maintaining optimal off-loading and ensuring patient compliance. In addition we will perform a randomized controlled trial of the LRD testing the hypothesis that the LRD will be equivalent in terms of clinical outcomes to the TCC in the treatment of patients with neuropathic foot ulcers. This product not only has commercial potential, but also offers the possibility of putting a tool into the hands of providers which could heal many ulcers faster than is usual at present and could therefore prevent many lower extremity amputations.

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

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