The Mount Sinai Diabetic Foot Ulcer Prospective Trial

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 13, 2018

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
DiabetesDiabetic Foot UlcerEdema
Interventions
DEVICE

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.

DEVICE

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.

Trial Locations (1)

10029

RECRUITING

Icahn School of Medicine at Mount Sinai, New York

All Listed Sponsors
lead

Windsor Ting

OTHER