60
Participants
Start Date
April 13, 2018
Primary Completion Date
December 31, 2024
Study Completion Date
December 31, 2024
Conventional Therapy
Local wound care consists of at least once daily dressing Occasionally, a limited bedside debridement is indicated to excise small quantity of devitalized tissues and to provide better drainage. Antibiotic therapy including both gram-positive and gram-negative coverage when the DFU appears infected is guided by wound cultures and when necessary, Infectious Disease consultation. Debridement and amputation will be performed as clinically indicated. To promote healing after the more acute processes have been addressed, pressure offloading is frequently helpful in the healing of DFU. Pressure offloading treatment ranges from special dressings and devices to special diabetic foot wares. Offloading will be utilized as indicated.
Venous Stent(s)
After PVOO is confirmed by venography and IVUS, and patient subject is randomized to conventional therapy and stent placement, stent placement is performed immediately at the same sitting.
RECRUITING
Icahn School of Medicine at Mount Sinai, New York
Windsor Ting
OTHER