The Mount Sinai Diabetic Foot Ulcer Prospective Trial

NCT03404895 | Unknown DMC FDA Device

• 1 other identifier: GCO 17-2608
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetes; Diabetic Foot Ulcer; Edema

Keywords

DFU; Vein; Stent

Outcome Measures

Primary Outcomes (1)

• Number of days to ulcer healing

  All patient subjects with an active ulcer will be followed until healing of the ulcer.

  average of 1 year

Secondary Outcomes (4)

• Number of subjects whose DFU persisted

  12 months

• Number of recurrent DFU

  12 months

• Total number of subjects with limb loss

  12 months

• Total number of subjects with minor and major amputations

  12 months

Study Arms (2)

Conventional Therapy

SHAM COMPARATOR

Conventional therapy of DFU comprises of four components: local wound care, antibiotic therapy, debridement and amputation, and pressure offloading.

Device: Conventional Therapy

Conventional Therapy + venous stent(s)

ACTIVE COMPARATOR

Patients will receive a venous stent in addition to conventional therapy

Device: Conventional Therapy; Device: Venous Stent(s)

Interventions

Conventional Therapy DEVICE

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.

Conventional Therapy; Conventional Therapy + venous stent(s)

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.

Conventional Therapy + venous stent(s)

Eligibility Criteria

• Age: 30 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Windsor Ting: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot; Edema

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Windsor Ting, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Mccracken

CONTACT

(212) 241-8708; Sarah.Mccracken@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Subjects are randomized in the OR to one of two study arms: conventional therapy vs. conventional therapy + venous stent(s).

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 19, 2018
• Study Start: April 13, 2018
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (1)