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

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02563522
Recruitment Status : Active, not recruiting
First Posted : September 30, 2015
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Helixmith Co., Ltd.

Tracking Information
First Submitted Date  ICMJE September 28, 2015
First Posted Date  ICMJE September 30, 2015
Last Update Posted Date August 14, 2019
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2018)
Confirmed target wound closure by the 4 month follow-up [ Time Frame: 0-4 Months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
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.
Change History Complete list of historical versions of study NCT02563522 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2018)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of VM202 in the Treatment of Chronic Non-Healing Foot Ulcers
Official Title  ICMJE 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)
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.
Detailed Description

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 29, 2015)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02563522
Other Study ID Numbers  ICMJE VMNHU-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Helixmith Co., Ltd.
Study Sponsor  ICMJE Helixmith Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Helixmith Co., Ltd.
Verification Date August 2019

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