Evaluating stents for healing diabetic foot ulcers
The Mount Sinai Diabetic Foot Ulcer Prospective Trial
This study is testing if putting stents in blocked leg veins can help people with diabetic foot ulcers heal faster when combined with regular treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 30 Years to 64 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT03404895 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess whether placing stents in blocked leg veins can enhance the healing process of diabetic foot ulcers (DFUs). It involves a single-center, patient-blinded, randomized controlled design where participants will undergo venogram and IVUS imaging to confirm the presence of iliac vein stenosis. Patients will then be randomized to receive either conventional therapy alone or conventional therapy combined with venous stenting. The study will follow participants monthly until their ulcers heal and then every three months for a year post-healing.
Who should consider this trial
Good fit: Ideal candidates include individuals with diabetic foot ulcers located distal to the ankle, lower extremity edema, and confirmed iliac vein stenosis.
Not a fit: Patients with previous vein stent implantation, known metal allergies, or acute deep venous thrombosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve healing rates for patients suffering from diabetic foot ulcers.
How similar studies have performed: While this approach is innovative, previous studies have indicated potential benefits of venous stenting in similar patient populations, suggesting a promising avenue for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Windsor Ting, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Sarah Mccracken
- Email: Sarah.Mccracken@mountsinai.org
- Phone: (212) 241-8708
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.