Toad Anti-Gravity (TAG) Brace
Ulcers on the bottom of the foot can be debilitating. If untreated, this can lead to amputation, especially in elderly patients with diabetes and other comorbidities. Plantar ulcers are difficult to heal in patients with diabetic neuropathy because of the lack of protective sensation in the foot. Consequently, multiple management algorithms including topical therapies, dressings and wound care are used with variable success of ulcer healing and amputation prevention. A key component in ulcer healing is off-loading the foot to allow the fragile tissue to heal without pressure. Total contact casts have been the gold standard for off-loading but are cumbersome to apply and reapply with up to 15 steps for the application. Total contact casts are contraindicated in patients with infected wounds that need frequent debridement. Other boots, half-shoes and devices do not uniformly off-load.
The Toad Medical Corporation TAG Brace study is a multicenter, single-blinded, randomized controlled trial testing the efficacy of a novel device that completely off-loads the foot and has been shown to heal ulcers at a rapid rate in preliminary experience in patients with plantar ulcers. Quantitative assessment of ulcer healing rates will be determined clinically and by blinded, computer-assisted planimetry of digital images over a 12-week period.
Key Inclusion Criteria
A patient is eligible for further screening if:
- 18 years of age
- Diagnosed with diabetes mellitus and a wound greater than two weeks in duration
- Has lower extremity ischemia and underwent successful revascularization procedure at least one month prior to randomization
- Ulcers with grade of 1A using the validated University of Texas Diabetic Foot Wound Classification system (i.e., superficial and not involving bone, capsule or tendon)
Patients will be excluded if:
- No successful revascularization is possible (in patients with ischemia)
- There is active infection
- Wounds are present on the calf or anterior leg that would have regular contact with the TAG brace
- Chronically bedridden
For more information, refer to www.toadmedical.com.
Contact Us for More Information
Vikram S. Kashyap, MD, Site Principal Investigator
216-844-1631 or Vikram.Kashyap@UHhospitals.org
Stacey Mazzurco, RN, CCRP, Director, Research & Innovation Center
216-844-3130 or Stacey.Mazzurco@UHhospitals.org
Lori Hammer, RN, BSN, Clinical Research Coordinator
216-983-4719 or Lori.Hammer@UHhospitals.org