Diabetic Foot Ulcer Device

Period of Performance: 09/30/1997 - 05/31/1998


Phase 1 SBIR

Recipient Firm

Rose Biomedical Development Corporation
Denver, CO 80220
Principal Investigator


Diabetic foot ulcers account for 55,000 amputations per year and are the leading cause of diabetic patient hospitalizations. Treatment requires off-weighting of the foot through bed rest, wheelchair, crutches, healing sandals, modified shoes, and/or bandaging treatments. Treatment compliance, however, is difficult to maintain since diabetics with peripheral neuropathy do not feel pain in the affected limbs. Total contact casts (TCC) off-weight the wound while allowing for ambulation and healing without strict patient compliance. TCC's facilitate healing in up to 90% of cases. Unfortunately, only a small percentage of patients receive this treatment because it requires extensive training, time consuming two person applications, and frequent follow-up recasting. In other words, TCCs are clinically-effective, but not cost-effective. RBDC proposes to develop the Fast Cast (FC) - a reusable, easy-to-apply, adjust and remove, ulcer healing system with the efficacy of TCC's. The FC will provide maximum off-weighting by shifting pressure from foot to lower leg. It will be easily adjusted as leg diameters change due to decreased edema and atrophy. The FC's ease of use should increase utilization rates, resulting in better diabetic foot ulcer treatment for more patients, lower related health care costs, fewer amputations and higher quality of life for diabetic patients. PROPOSED COMMERCIAL APPLICATIONS: Of the 14 million diagnosed diabetics in the U.S., 15% or approximately 2.1 million patients suffer from foot ulcers. Each year 55,000 of these ulcers lead to amputations. If the proposed Fast Cast proves efficacious, this new device will join the substantial market of foot ulcer treatment devices. Further, the Fast Cast's low cost and ease of application a adjustment will allow it to significantly penetrate this market.