Safety and Efficacy Study of VM202 in the Treatment of Chronic Non-Healing Foot Ulcers
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| ClinicalTrials.gov Identifier: NCT02563522 |
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Recruitment Status :
Active, not recruiting
First Posted : September 30, 2015
Last Update Posted : August 14, 2019
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Sponsor:
Helixmith Co., Ltd.
Information provided by (Responsible Party):
Helixmith Co., Ltd.
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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 |
| Actual 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
Locations
Show 22 study locations
Sponsors and Collaborators
Helixmith 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: | Helixmith Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT02563522 |
| Other Study ID Numbers: |
VMNHU-003 |
| First Posted: | September 30, 2015 Key Record Dates |
| Last Update Posted: | August 14, 2019 |
| Last Verified: | August 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Helixmith Co., Ltd.:
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non healing ulcers VM202 Diabetic ulcers foot ulcers |
Additional relevant MeSH terms:
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Diabetic Foot Foot Ulcer Ulcer Pathologic Processes Foot Diseases Skin Diseases Leg Ulcer Skin Ulcer |
Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies |