DiabetesNCT03404895
The Mount Sinai Diabetic Foot Ulcer Prospective Trial
A study testing Conventional Therapy and Venous Stent(s) in people with Diabetes and Diabetic Foot Ulcer, run by Windsor Ting at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether placing stent(s) for a blockage in a leg vein will help improve the healing of diabetic foot ulcers (DFU). The investigators know from having taken care of many patients with diabetic foot ulcers that it is a major cause of disability and amputation. Read more about this study
- Who is it for?
- Ages 30 to 64 years
- Conditions the study is for
- Diabetes, Diabetic Foot Ulcer, Edema
- What is being tested?
- Conventional Therapy and Venous Stent(s)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2018to 10 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Venous compression caused by tumor encasement
- Venous outflow obstruction caused by tumor thrombus
- Elevated baseline blood creatinine (>1.5)
- Pregnancy
- Life expectancy <12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
The purpose of this study is to evaluate whether placing stent(s) for a blockage in a leg vein will help improve the healing of diabetic foot ulcers (DFU). The investigators know from having taken care of many patients with diabetic foot ulcers that it is a major cause of disability and amputation. These diabetic foot ulcers frequently heal slowly or not at all. They sometimes become infected and require antibiotic therapy, debridement and amputation. The investigators normally take care of a diabetic foot ulcer with a combination of local wound care, surgical debridement if necessary, antibiotics if there is an infection, and reduction of pressure on the area of the foot with the ulcer. The investigators observed that some patients with a diabetic foot ulcer also have a blockage in a major leg vein referred to as the iliac vein. This blockage in the iliac vein prevents the proper flow of blood from the leg. This blockage results in pressure within the leg veins leading to swelling in the legs which may also prevent healing of the diabetic foot ulcer. This study will investigate whether placing stent(s) to treat the blockage(s) will improve healing of the diabetic foot ulcer and reduce some of the complications associated with a diabetic foot ulcer. The results of this study could result in a new treatment that will allow future patients with diabetic foot ulcers to heal better. Right now, placing stents for these blockages in the iliac vein is not the standard of care treatment for a diabetic foot ulcer. In order for us to determine whether stent placement is helpful, the researchers will have to randomize each patient. In other words, to reduce bias, patients will be assigned either to a group receiving a stent or to a group not receiving a stent. Every patient in both groups will receive the standard of care for a diabetic foot ulcer and undergo an x-ray with contrast and intravenous ultrasound examination of the legs. The standard of care for a diabetic foot ulcer may include local wound care, antibiotic therapy, debridement and/or amputation, and pressure offloading in the foot.
Read the 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.
- Conditions
- Diabetes, Diabetic Foot Ulcer, Edema
- Being tested
- Conventional Therapy, Venous Stent(s)
- Keywords
- DFU, Vein, Stent
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional TherapyDevice
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)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Therapy | Sham comparator | Conventional therapy of DFU comprises of four components: local wound care, antibiotic therapy, debridement and amputation, and pressure offloading. Receives: Device: Conventional Therapy |
| Conventional Therapy + venous stent(s) | Active comparator | Patients will receive a venous stent in addition to conventional therapy Receives: Device: Conventional Therapy; Device: Venous Stent(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days to ulcer healing
All patient subjects with an active ulcer will be followed until healing of the ulcer.
Measured: average of 1 year
Secondary outcomes (4)
Number of subjects whose DFU persisted
Number of subjects whose DFU persisted 12 months post-randomization
Measured: 12 months
Number of recurrent DFU
Number of subjects who had recurrent DFU 12 months post-randomization
Measured: 12 months
Total number of subjects with limb loss
Number of subjects who had limb loss within 12 months post-randomization
Measured: 12 months
Total number of subjects with minor and major amputations
Number of subjects who had major or minor amputations within 12 months post-randomization
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start13 Apr 2018
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
Why it stopped: Difficulty enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects are randomized in the OR to one of two study arms: conventional therapy vs. conventional therapy + venous stent(s).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Windsor Ting
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Windsor Ting, Icahn School of Medicine at Mount Sinai
- Investigators
- Windsor Ting, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404895
- Sponsor's protocol ID
- GCO 17-2608
- Status last verified
- May 2026
- First submitted
- 12 Jan 2018
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mount Sinai Diabetic Foot Ulcer Prospective Trial
- ClinicalTrials.gov ID
- NCT03404895
- Acronym / sponsor ID
- GCO 17-2608
- Conditions
- Diabetes, Diabetic Foot Ulcer, Edema
- Keywords
- DFU, Vein, Stent
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Windsor TingUniversity, hospital or other
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether placing stent(s) for a blockage in a leg vein will help improve the healing of diabetic foot ulcers (DFU). The investigators know from having taken care of many patients with diabetic foot ulcers that it is a major cause of disability and amputation. These diabetic foot ulcers frequently heal slowly or not at all. They sometimes become infected and require antibiotic therapy, debridement and amputation. The investigators normally take care of a diabetic foot ulcer with a combination of local wound care, surgical debridement if necessary, antibiotics if there is an infection, and reduction of pressure on the area of the foot with the ulcer. The investigators observed that some patients with a diabetic foot ulcer also have a blockage in a major leg vein referred to as the iliac vein. This blockage in the iliac vein prevents the proper flow of blood from the leg. This blockage results in pressure within the leg veins leading to swelling in the legs which may also prevent healing of the diabetic foot ulcer. This study will investigate whether placing stent(s) to treat the blockage(s) will improve healing of the diabetic foot ulcer and reduce some of the complications associated with a diabetic foot ulcer. The results of this study could result in a new treatment that will allow future patients with diabetic foot ulcers to heal better. Right now, placing stents for these blockages in the iliac vein is not the standard of care treatment for a diabetic foot ulcer. In order for us to determine whether stent placement is helpful, the researchers will have to randomize each patient. In other words, to reduce bias, patients will be assigned either to a group receiving a stent or to a group not receiving a stent. Every patient in both groups will receive the standard of care for a diabetic foot ulcer and undergo an x-ray with contrast and intravenous ultrasound examination of the legs. The standard of care for a diabetic foot ulcer may include local wound care, antibiotic therapy, debridement and/or amputation, and pressure offloading in the foot.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Subjects are randomized in the OR to one of two study arms: conventional therapy vs. conventional therapy + venous stent(s).
| Arm | Type | Receives |
|---|---|---|
| Conventional Therapy | Sham comparator | Device: Conventional TherapyConventional therapy of DFU comprises of four components: local wound care, antibiotic therapy, debridement and amputation, and pressure offloading. |
| Conventional Therapy + venous stent(s) | Active comparator | Device: Conventional Therapy, Device: Venous Stent(s)Patients will receive a venous stent in addition to conventional therapy |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional TherapyLocal 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 | Conventional Therapy, Conventional Therapy + venous stent(s) |
| 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. | Device | Conventional Therapy + venous stent(s) |
Primary outcome
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.
4 secondary outcomes
Number of subjects whose DFU persisted
Time frame: 12 months
Number of recurrent DFU
Time frame: 12 months
Total number of subjects with limb loss
Time frame: 12 months
Total number of subjects with minor and major amputations
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Windsor Ting, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Therapy and Venous Stent(s) in people with Diabetes and Diabetic Foot Ulcer, run by Windsor Ting at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days to ulcer healing (time frame: average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.