Your session is about to expire
← Back to Search
Other
Venous Stents for Diabetic Foot Ulcers
N/A
Recruiting
Led By Windsor Ting, MD
Research Sponsored by Windsor Ting
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of diabetic foot ulcer within the foot (located distal to the ankle and proximal to base of toes)
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up average of 1 year
Awards & highlights
Study Summary
This trial is testing whether placing a stent in a blocked leg vein will help improve healing in diabetic foot ulcers, which often don't heal well or at all.
Who is the study for?
This trial is for people with diabetic foot ulcers, leg swelling due to a blocked vein (iliac vein stenosis), and at least one good pulse in their foot or normal ankle-brachial index. It's not for those who are pregnant, allergic to iodine contrast or metals, have had previous leg stent/bypass surgery, acute deep venous thrombosis, kidney issues (high creatinine), cancer-caused blockages, or a life expectancy under 12 months.Check my eligibility
What is being tested?
The study tests if placing stents in the iliac vein can help heal diabetic foot ulcers better than standard treatments alone. Patients will be randomly assigned to receive either conventional therapy plus a venous stent(s) or just conventional care including wound care and pressure offloading.See study design
What are the potential side effects?
Potential side effects may include reactions to the contrast dye used during imaging (like rash or itching), complications from the procedure such as infection or blood clots, and general risks associated with surgical interventions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a diabetic foot ulcer between my ankle and the base of my toes.
Select...
My scans show a narrowed iliac vein or signs suggesting it might be narrowed.
Select...
I have swelling in my legs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of days to ulcer healing
Secondary outcome measures
Number of recurrent DFU
Number of subjects whose DFU persisted
Total number of subjects with limb loss
+1 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Conventional Therapy + venous stent(s)Active Control2 Interventions
Patients will receive a venous stent in addition to conventional therapy
Group II: Conventional TherapyPlacebo Group1 Intervention
Conventional therapy of DFU comprises of four components: local wound care, antibiotic therapy, debridement and amputation, and pressure offloading.
Find a Location
Who is running the clinical trial?
Windsor TingLead Sponsor
1 Previous Clinical Trials
1,000 Total Patients Enrolled
Windsor Ting, MD5.030 ReviewsPrincipal Investigator - Icahn School of Medicine at Mount Sinai
Medical School - Tufts University, Doctor of Medicine
Columbia-Presbyterian Medical Center, Residency in General Surgery
1 Previous Clinical Trials
1,000 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a recent deep vein clot in my leg.I have a history of long-term vein blockage in my leg.You are not expected to live for more than a year.I have a diabetic foot ulcer between my ankle and the base of my toes.You have a known allergic reaction to iodine-based contrast dye that cannot be treated with medication beforehand.You have had a stent put in the vein in your leg or abdomen before.My scans show a narrowed iliac vein or signs suggesting it might be narrowed.You must have a strong pulse in your foot or a specific measurement of blood flow in your leg veins.I have had surgery or a procedure on the leg being studied.I have swelling in my legs.Your blood creatinine level is higher than 1.5.You have a known allergy to metal.My tumor is pressing on a vein.My cancer has caused a blockage in my veins.
Research Study Groups:
This trial has the following groups:- Group 1: Conventional Therapy
- Group 2: Conventional Therapy + venous stent(s)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment for this trial capped at any particular age?
"The age range needed to qualify for this research study is between 30 and 64 years old."
Answered by AI
To what extent is the patient group size limited for this medical experiment?
"Affirmative. According to clinicaltrials.gov, this medical investigation is presently looking for enrollees. It was initially posted on April 13th 2018 and has been recently updated as of October 3rd 2022; 60 participants are being sought from a single institution."
Answered by AI
Is eligibility still open to join this research study?
"Aspiring participants of this trial must be between 30 and 64 years old, suffer from ulcer, and should know that the study is looking to recruit a total of 60 individuals."
Answered by AI
Are new participants being accepted for this trial currently?
"As per the information on clinicaltrials.gov, this medical experiment is currently accepting participants. This trial was first advertised in April 2018 and most recently adjusted in October 2022."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Icahn School of Medicine at Mount Sinai
Why did patients apply to this trial?
I had my big toe amputed over 2 years ago. Got infection amputed rest of toes th aug.2023 infection cause almost 1/2 right foot amputated they talking more surgery because it's not healing right. I'm trying to heal my foot anyway possible....
PatientReceived 1 prior treatment
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger