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Efficacy of TR 987, Beta-1,3-1,6-D-glucan, in the Treatment of Chronic Venous Insufficiency Ulcers

Sponsor
SerenaGroup, Inc. (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03154619
Collaborator
TR Therapeutics (Industry)
80
Enrollment
9
Locations
2
Arms
53
Duration (Months)
8.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 0.1% TR 987
  • Drug: Placebo gel
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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.
Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
Apr 4, 2019
Anticipated Study Completion Date :
Apr 1, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: 0.1% TR 987
TR 987 0.1%
Other Names:
  • Beta glucan

    		•
    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.

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Time to complete wound closure [12 weeks]

    Secondary Outcome Measures

    1. Percentage of subjects with complete ulcer healing [12 weeks]

    2. Change in ulcer size [4 weeks]

    3. Change in ulcer size [12 weeks]

    4. Incidence of adverse events [12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New Hope Podiatry Clinic Los Angeles California United States 90063
    2 Barry University Clinical Research North Miami Beach Florida United States 33169
    3 Royal Research Corp Pembroke Pines Florida United States 33027
    4 Deborah Heart and Lung Center Browns Mills New Jersey United States 08015
    5 Cleveland Foot and Ankle Clinic Cleveland Ohio United States 44103
    6 The Foot and Ankle Wellness Center Ford City Pennsylvania United States 16226
    7 Armstrong County Memorial Hospital Kittanning Pennsylvania United States 16201
    8 SerenaGroup Research Institute Pittsburgh Pennsylvania United States 15222
    9 Martin Foot and Ankle York Pennsylvania United States 17402

    Sponsors and Collaborators

    • SerenaGroup, Inc.
    • TR Therapeutics

    Investigators

    • Principal Investigator: Thomas Serena, MD, SerenaGroup, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SerenaGroup, Inc.
    ClinicalTrials.gov Identifier:
    NCT03154619
    Other Study ID Numbers:
    • BG001
    First Posted:
    May 16, 2017
    Last Update Posted:
    Oct 22, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Varicose Ulcer
    Venous Insufficiency
    Leg Ulcer
    Ulcer

    Study Results

    No Results Posted as of Oct 22, 2020