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Efficacy of TR 987, Beta-1,3-1,6-D-glucan, in the Treatment of Chronic Venous Insufficiency 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. 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: NCT03154619
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
TR Therapeutics, Inc.
Information provided by (Responsible Party):
SerenaGroup, Inc.

Tracking Information
First Submitted Date  ICMJE May 12, 2017
First Posted Date  ICMJE May 16, 2017
Last Update Posted Date April 4, 2019
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2017)
Time to complete wound closure [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03154619 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2017)
  • Percentage of subjects with complete ulcer healing [ Time Frame: 12 weeks ]
  • Change in ulcer size [ Time Frame: 4 weeks ]
  • Change in ulcer size [ Time Frame: 12 weeks ]
  • Incidence of adverse events [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of TR 987, Beta-1,3-1,6-D-glucan, in the Treatment of Chronic Venous Insufficiency Ulcers
Official Title  ICMJE Efficacy of TR 987, Beta-1,3-1,6-D-glucan, in the Treatment of Chronic Venous Insufficiency Ulcers: a Two-arm, Double-blind, Placebo-controlled, Randomized Controlled Trial.
Brief Summary The safety and efficacy of beta glucan products, and specifically TR 987, in the treatment of chronic venous insufficiency ulcers has been established. This study is designed to determine the most efficient method of treatment.
Detailed Description This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the effectiveness of TR 987 gel. It is a two-arm, design: One group will receive twice-weekly applications of 0.1% TR 987 in a gel base plus SoC for the first 4 weeks. The other group will receive twice-weekly applications of placebo gel base plus SoC for the same period of time. After 4 weeks, both groups will receive once weekly applications of their assigned treatment for the remaining 8 weeks of the trial. The Standard of Care therapy in this study is multi-layer compression therapy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Venous Leg Ulcer
Intervention  ICMJE
  • Drug: 0.1% TR 987
    TR 987 0.1%
    Other Name: Beta glucan
  • Drug: Placebo gel
    Placebo gel twice weekly for 4 weeks, then once weekly for 8 weeks. Gel will be applied to cover the wound cavity and wound surface to a thickness of 5 mm.
Study Arms  ICMJE
  • Active Comparator: TR987
    This group will receive twice-weekly applications of 0.1% TR 987 in a gel base plus SoC for the first 4 weeks, then once weekly applications for the remaining 8 weeks of the trial.
    Intervention: Drug: 0.1% TR 987
  • Placebo Comparator: Placebo
    This group will receive twice-weekly applications of placebo gel base plus SoC for the first 4 weeks, then once weekly applications for the remaining 8 weeks of the trial.
    Intervention: Drug: Placebo gel
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 12, 2017)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject is at least 18 years old
  2. Female subjects are not pregnant or breastfeeding.
  3. Study ulcer has been present for at least one month and has undergone more than 2 weeks, but less than 12 months of continuous high-strength compression with less than 40% healing.
  4. Study ulcer is a minimum of 2.0 cm2 and a maximum of 20.0 cm2, extending through the full thickness of the skin, but not down to muscle, tendon, or bone at the randomization visit.
  5. Study ulcer has a clean, granulating base with minimal adherent slough at the randomization visit.
  6. If more than one ulcer is present on the same leg, they must be more than 2 cm apart and only the larger ulcer will be included in the study.
  7. Adequate arterial flow, as measured by an Ankle Brachial Pressure Index (ABI) of greater than 0.75. (Calculations will be made using measurements from both posterior tibial and dorsalis pedis arteries, as well as both arms) and/or Skin Perfusion Pressure (SPP) >30.
  8. Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
  9. Patient understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
  10. Patient has read and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.

Exclusion Criteria:

  1. Study ulcer deemed by the Investigator to be caused by a medical condition other than venous insufficiency.
  2. Study ulcer exhibits clinical signs and symptoms of infection.
  3. Study ulcer requires enzymatic debridement during the study.
  4. Study ulcer has undergone 12 or more months of continuous high-strength compression therapy over its duration.
  5. Study ulcer is less than 2.0 cm2 or greater than 20.0 cm2.
  6. Study ulcer extends more than 50% below the malleolus.
  7. Study ulcer is treated with a topical antibiotic during the screening phase.
  8. Study ulcer has been treated with tissue engineered material (e.g., Apligraf® or Dermagraft®) or other scaffold materials (e.g., Oasis or Matristem) within 30 days prior to the TV1 Randomization visit.
  9. Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the course of the trial.
  10. History of radiation at the study ulcer site.
  11. Study ulcer decreases in area by 30% or more during the 14 days screening period.
  12. Subjects who are unable to understand the aims and objectives of the trial or has a known history of poor adherence with medical treatment.
  13. Presence of any condition(s) that seriously compromises the subject's ability to complete this study.
  14. All females of childbearing potential who are not using a highly effective method of birth control (failure rate less than 1% per year), such implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Raphael Yaakov, MS 6179455225 ryaakov@serenagroups.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03154619
Other Study ID Numbers  ICMJE BG001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party SerenaGroup, Inc.
Study Sponsor  ICMJE SerenaGroup, Inc.
Collaborators  ICMJE TR Therapeutics, Inc.
Investigators  ICMJE
Principal Investigator: Thomas Serena, MD SerenaGroup, Inc.
PRS Account SerenaGroup, Inc.
Verification Date April 2019

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