Safety and Efficacy Study of VM202 in the Treatment of Chronic Non-Healing Foot Ulcers
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02563522 |
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Recruitment Status :
Recruiting
First Posted : September 30, 2015
Last Update Posted : November 1, 2018
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Sponsor:
ViroMed Co., Ltd.
Information provided by (Responsible Party):
ViroMed Co., Ltd.
- Study Details
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Brief Summary:
This study will assess the safety and efficacy of using gene therapy via intramuscular injections of the calf for patients with chronic non-healing foot ulcers.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Foot Ulcer, Diabetic | Genetic: VM202 Drug: Placebo | Phase 3 |
A phase III, randomized, double-blind, placebo-controlled, multicenter, 7-month study designed to assess the safety and efficacy of intramuscular (IM) injections in the calf of VM202 in patients with chronic nonhealing foot ulcers. Three hundred patients will be randomized in a 2:1 ratio of VM202 or placebo injections:
- Active -VM202 + standard of care - 200 patients
- Control - Placebo (VM202 Vehicle) + standard of care - 100 patients
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Active: VM202 + standard of care - 200 subjects Control: Placebo (VM202 vehicle) + standard of care - 100 subjects |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Asses the Safety and Efficacy of VM202 to Treat Chronic Nonhealing Foot Ulcers in Diabetic Patients With Concomitant Peripheral Arterial Disease (PAD) |
| Actual Study Start Date : | January 2017 |
| Estimated Primary Completion Date : | June 2019 |
| Estimated Study Completion Date : | December 2019 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Active
VM202 + standard of care
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Genetic: VM202
gene therapy |
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Placebo Comparator: Control
Placebo (VM202 Vehicle) + standard of care
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Drug: Placebo
Standard of care plus placebo
Other Name: VM202 vehicle |
Primary Outcome Measures :
- Confirmed target wound closure by the 4 month follow-up [ Time Frame: 0-4 Months ]
Secondary Outcome Measures :
- Time to complete wound closure of foot ulcer [ Time Frame: Days 0 to Month 7 ]The time until confirmed target wound closure
- Time to the amputations [ Time Frame: Day 0 to Month 7 ]how long until amputation occurred
- Change in ankle brachial index (ABI) [ Time Frame: at 4 months, and 7 months ]change in ABI at 4 and 7 months
- Change in toe brachial index (TBI) [ Time Frame: at 4 months, and 7 months ]Change in TBI at 4 and 7 months
- Change in score of each domain on the CWIQ [ Time Frame: from baseline at 4 months and 7 month ]
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Documented symptomatic PAD
- Documented history of Type I or II diabetes with current treatment control (HbA1c of ≤ 12.0% at Screening) and currently on oral medication and / or insulin
- No significant changes anticipated in diabetes medication regimen
- At Screening, subject has one ulcer on the target foot
- Subjects will undergo protocol-defined standardized wound care during screening (for two weeks or longer).
Exclusion Criteria:
- Will require revascularization in the target leg within 3 months of randomization
- In the investigator's assessment, will require an amputation in the target leg within 3 months of randomization
- Subject diagnosed with critical limb ischemia (CLI; Rutherford score ≥ 4)
- Evidence of active infection (e.g., cellulitis, osteomyelitis) or deep ulceration exposing bone or tendon in the foot planned for treatment
- Current fracture in the target foot
- Heart Failure with a New York Heart Association (NYHA) classification of III or IV;
- Body mass index (BMI) > 45 kg/m2 at Screening
- Unstable angina
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563522
Contacts
| Contact: Sheila Yi | sheila@viromed.co.kr |
Locations
| United States, Alabama | |
| Central Research Associates, Inc. | Recruiting |
| Birmingham, Alabama, United States, 35205 | |
| Contact: William Whitley, Pharm D | |
| Principal Investigator: Jeffrey Davis, MD | |
| United States, Arizona | |
| Arizona Research Center | Recruiting |
| Phoenix, Arizona, United States, 85053 | |
| Principal Investigator: Joseph Gimbel, MD | |
| University of Arizona | Recruiting |
| Tucson, Arizona, United States, 85724 | |
| Principal Investigator: Eric Espensen, DPM | |
| United States, Arkansas | |
| NEA Baptist | Recruiting |
| Jonesboro, Arkansas, United States, 72401 | |
| Principal Investigator: Christopher Rowlett, DPM | |
| United States, California | |
| Sacramento Foot and Ankle | Recruiting |
| Carmichael, California, United States, 95608 | |
| Principal Investigator: Gregory Tovmassian, DPM | |
| Bay Area Foot and Ankle | Recruiting |
| Castro Valley, California, United States, 94546 | |
| Principal Investigator: Mher Vartivarian, DPM | |
| VA Long Beach Healthcare System | Recruiting |
| Long Beach, California, United States, 90822 | |
| Principal Investigator: Ian Gordon, MD | |
| Foot and Ankle Clinic | Recruiting |
| Los Angeles, California, United States, 90057 | |
| Principal Investigator: Felix Sigal, DPM | |
| USC Keck School of Medicine | Recruiting |
| Los Angeles, California, United States | |
| Principal Investigator: David Armstrong | |
| Center for Clinical Research Inc. | Recruiting |
| San Francisco, California, United States, 94115 | |
| Principal Investigator: Alexander Reyzelman, DPM | |
| Olive View-UCLA Education & Research Institute | Recruiting |
| Sylmar, California, United States, 91342 | |
| Principal Investigator: Aksone Nouvong, DPM | |
| United States, Florida | |
| LCC Medical Research Institute | Recruiting |
| Miami, Florida, United States, 33126 | |
| Contact: , MD | |
| Principal Investigator: Jacob Silverstone, DPM | |
| Miami Dade Medical Research Institute, LLC | Recruiting |
| Miami, Florida, United States, 33176 | |
| Principal Investigator: Francisco Oliva, DPM | |
| United States, Illinois | |
| Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: Karen Ho, MD | |
| United States, Massachusetts | |
| UMASS Memorial Med Center | Recruiting |
| Worcester, Massachusetts, United States, 01655 | |
| Principal Investigator: Edward Arous, MD | |
| United States, Missouri | |
| Saint Louis University | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Principal Investigator: Catherine Wittgen, MD | |
| United States, Nevada | |
| Advanced Foot & Ankle Center | Recruiting |
| Las Vegas, Nevada, United States, 89119 | |
| Principal Investigator: Cyaandi Dove, DPM | |
| United States, Oregon | |
| Oregon Foot and Ankle Center | Recruiting |
| Eugene, Oregon, United States, 97401 | |
| Principal Investigator: Lacey Loveland, DPM | |
| United States, Texas | |
| MedResearch, Inc | Recruiting |
| El Paso, Texas, United States, 79932 | |
| Principal Investigator: Gil M Moreu, DPM | |
| Acclaim Bone & Joint Institute | Recruiting |
| Fort Worth, Texas, United States, 76107 | |
| Principal Investigator: Travis Motley, DPM | |
| Texas Heart Institute | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Nichole Piece | |
| Principal Investigator: Emerson Perin, MD | |
| Futuro Clinical Trials | Recruiting |
| McAllen, Texas, United States, 78501 | |
| Principal Investigator: Joseph Caporusso, DPM | |
Sponsors and Collaborators
ViroMed Co., Ltd.
Investigators
| Principal Investigator: | Emerson C. Perin, MD | Texas Heart Institute | |
| Principal Investigator: | David G Armstrong,, DPM, MD, PhD | Keck School of Medicine of University of Southern California |
| Responsible Party: | ViroMed Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT02563522 History of Changes |
| Other Study ID Numbers: |
VMNHU-003 |
| First Posted: | September 30, 2015 Key Record Dates |
| Last Update Posted: | November 1, 2018 |
| Last Verified: | October 2018 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by ViroMed Co., Ltd.:
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non healing ulcers VM202 Diabetic ulcers foot ulcers |
Additional relevant MeSH terms:
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Ulcer Foot Ulcer Peripheral Arterial Disease Diabetic Foot Pathologic Processes Foot Diseases Skin Diseases Leg Ulcer Skin Ulcer Atherosclerosis |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Peripheral Vascular Diseases Diabetic Angiopathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies |