- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03404895
The Mount Sinai Diabetic Foot Ulcer Prospective Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This will be a single center, patient-blinded, randomized controlled trial. In the event that a patient does not meet inclusion criteria after signing the consent for and undergoing venogram/IVUS (screen fail), additional patients will be enrolled until 60 patients have been successfully randomized. Up to 80 patients will be consented in order to account for potential screen fails. Randomized patients will be followed monthly until their ulcer heals, every 3 months after healing for one year postoperatively.
Every patient subject will undergo venogram & IVUS. The investigator experience with over 600 patients who underwent venous stenting at Mount Sinai - all of whom had preoperative MR venogram or CT venogram - revealed that pre-operative imaging missed the diagnosis of PVOO in approximately 10% of patients (this is unpublished data). Due to the small sample size of this pilot study, the very low risks associated with venogram and IVUS, and the 100% accuracy of venogram and IVUS in diagnosing PVOO, every study subject will undergo these two imaging studies. Once the diagnosis of PVOO is confirmed, the study subject will be immediately randomized in the OR. Study subjects randomized to convention therapy plus venous stents will undergo venous stent placement at the same sitting. For study subjects randomized to conventional therapy alone, the procedure will be terminated after venogram and IVUS.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sarah Mccracken
- Phone Number: (212) 241-8708
- Email: Sarah.Mccracken@mountsinai.org
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Recruiting
- Icahn School Of Medicine At Mount Sinai
-
Principal Investigator:
- Windsor Ting, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Presence of diabetic foot ulcer within the foot (located distal to the ankle and proximal to base of toes)
- Lower extremity edema
- MRA or CTA showing stenosis of iliac vein or indirect findings that suggest presence of iliac vein stenosis (distal venous dilation and presence of collateral veins)
- At least one palpable pedal pulse or ABI>0.9 IVUS confirmation of iliac vein stenosis
Exclusion Criteria:
- Previous vein stent implantation involving study leg or inferior vena cava
- Previous bypass surgery or endovascular intervention involving study leg
- Known metal allergy
- Known reaction or sensitivity to iodinated contrast that cannot be managed with premedication
- Acute deep venous thrombosis involving either leg
- Known history of chronic occlusion of any vein in the study leg
- Venous compression caused by tumor encasement
- Venous outflow obstruction caused by tumor thrombus
- Elevated baseline blood creatinine (>1.5)
- Pregnancy
- Life expectancy <12 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Conventional Therapy
Conventional therapy of DFU comprises of four components: local wound care, antibiotic therapy, debridement and amputation, and pressure offloading.
|
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.
|
Active Comparator: Conventional Therapy + venous stent(s)
Patients will receive a venous stent in addition to 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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of days to ulcer healing
Time Frame: average of 1 year
|
All patient subjects with an active ulcer will be followed until healing of the ulcer.
|
average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects whose DFU persisted
Time Frame: 12 months
|
Number of subjects whose DFU persisted 12 months post-randomization
|
12 months
|
Number of recurrent DFU
Time Frame: 12 months
|
Number of subjects who had recurrent DFU 12 months post-randomization
|
12 months
|
Total number of subjects with limb loss
Time Frame: 12 months
|
Number of subjects who had limb loss within 12 months post-randomization
|
12 months
|
Total number of subjects with minor and major amputations
Time Frame: 12 months
|
Number of subjects who had major or minor amputations within 12 months post-randomization
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Windsor Ting, MD, Icahn School Of Medicine At Mount Sinai
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 17-2608
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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