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Trial record 2 of 16 for:    Viromed

Safety and Efficacy Study of VM202 in the Treatment of Chronic Non-Healing Foot Ulcers

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ClinicalTrials.gov Identifier: NCT02563522
Recruitment Status : Recruiting
First Posted : September 30, 2015
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
ViroMed Co., Ltd.

September 28, 2015
September 30, 2015
July 20, 2018
January 2017
June 2019   (Final data collection date for primary outcome measure)
Confirmed target wound closure by the 4 month follow-up [ Time Frame: 0-4 Months ]
Confirmed target wound closure by the 4 month follow-up [ Time Frame: 0-4 Months ]
The proportion of subjects with a confirmed target wound closure by the 4 month follow-up. Complete wound closure is defined as skin re-epithelialization without drainage or dressing confirmed at two consecutive study visits at least two weeks apart.
Complete list of historical versions of study NCT02563522 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Time to complete wound closure of foot ulcer [ Time Frame: Days 0 to Month 7 ]
  • Proportion of subjects with a confirmed target wound closure prior to or at 7 months [ Time Frame: Days 0, 60, 74, 90, 120, 210 ]
  • Percent change in wound volume [ Time Frame: at 2 months, 3 months, 4 months, and 7 months ]
  • Percent change in wound area and wound depth [ Time Frame: at 2 months, 3 months, 4 months, and 7 months ]
  • Proportion of subjects with formation of new ulcers on the target foot [ Time Frame: at 2 months, 3 months, 4 months, and 7 months ]
  • Time to the major amputations [ Time Frame: Day 0 to Month 7 ]
  • Time to the minor amputation [ Time Frame: Day 0 tp Month 7 ]
  • Change in ankle brachial index (ABI) [ Time Frame: at 4 months, and 7 months ]
  • Change in toe brachial index (TBI) [ Time Frame: at 4 months, and 7 months ]
  • Change in each domain score (quality of life, social life, well-being, physical symptoms and daily living) of Cardiff Wound Impact Questionnaire (CWIQ) [ Time Frame: from baseline at 4 months and 7 month ]
Not Provided
Not Provided
 
Safety and Efficacy Study of VM202 in the Treatment of Chronic Non-Healing Foot Ulcers
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)
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.

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
Interventional
Phase 3
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
Foot Ulcer, Diabetic
  • Genetic: VM202
    gene therapy
  • Drug: Placebo
    Standard of care plus placebo
    Other Name: VM202 vehicle
  • Active Comparator: Active
    VM202 + standard of care
    Intervention: Genetic: VM202
  • Placebo Comparator: Control
    Placebo (VM202 Vehicle) + standard of care
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Same as current
December 2019
June 2019   (Final data collection date for primary outcome measure)

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
  • Unhealed prior amputation
  • 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)
  • More than one (1) ulcer on target foot
  • 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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact: Sheila Yi sheila@viromed.co.kr
United States
 
 
NCT02563522
VMNHU-003
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
ViroMed Co., Ltd.
ViroMed Co., Ltd.
Not Provided
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
ViroMed Co., Ltd.
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP