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Diabetic Foot Ulcer Healing by Load Relieving Dressings

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
60903
Program Year/Program:
2005 / SBIR
Agency Tracking Number:
DK062547
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
DIAPEDIA, LLC
270 WALKER DR., STE 207E STATE COLLEGE, PA 16801-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2005
Title: Diabetic Foot Ulcer Healing by Load Relieving Dressings
Agency: HHS
Contract: 2R44DK062547-02
Award Amount: $1,146,073.00
 

Abstract:

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.

Principal Investigator:

Joseph L. Loomis
8142340700
JLOOMIS@DIAPEDIA.COM

Business Contact:

Martin Bradley
8142340700
MBRADLEY@DIAPEDIA.COM
Small Business Information at Submission:

Diapedia, LLC
Diapedia, Llc 200 Innovation Blvd, Ste 240 State College, PA 16803

EIN/Tax ID: 251858279
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No