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

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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.

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
Venous Leg Ulcer 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

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 Name: 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.




Primary Outcome Measures :
  1. Time to complete wound closure [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Percentage of subjects with complete ulcer healing [ Time Frame: 12 weeks ]
  2. Change in ulcer size [ Time Frame: 4 weeks ]
  3. Change in ulcer size [ Time Frame: 12 weeks ]
  4. Incidence of adverse events [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03154619


Contacts
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Contact: Raphael Yaakov, MS 6179455225 ryaakov@serenagroups.com

Locations
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United States, California
New Hope Podiatry Clinic Recruiting
Los Angeles, California, United States, 90063
Contact: Francis Morfin    323-264-6157    francis_morfin@yahoo.com   
Principal Investigator: Gabriel Halperin, DPM         
United States, Florida
GF Professional Research Withdrawn
Miami Lakes, Florida, United States, 33016
Barry University Clinical Research Recruiting
North Miami Beach, Florida, United States, 33169
Contact: Maria Swartz       MSwartz@barry.edu   
Principal Investigator: Robert Snyder, DPM         
Royal Research Corp Recruiting
Pembroke Pines, Florida, United States, 33027
Contact: Yalily Perez       yalilyp@royalresearchcorp.com   
Principal Investigator: Neal Bullock, DPM         
United States, New Jersey
Deborah Heart and Lung Center Recruiting
Browns Mills, New Jersey, United States, 08015
Contact: Lisa Romano       RomanoL@Deborah.org   
Principal Investigator: Vikram Palkar, DO         
United States, Ohio
Cleveland Foot and Ankle Clinic Recruiting
Cleveland, Ohio, United States, 44103
Contact: Stacy Coe       scoe3@kent.edu   
Principal Investigator: Windy Cole, DPM         
United States, Pennsylvania
Summit Health Hospital Withdrawn
Chambersburg, Pennsylvania, United States, 17201
The Foot and Ankle Wellness Center Active, not recruiting
Ford City, Pennsylvania, United States, 16226
Armstrong County Memorial Hospital Recruiting
Kittanning, Pennsylvania, United States, 16201
Contact: Keyur Patel, MD    724-543-8893      
SerenaGroup Research Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15222
Contact: Laura Serena    412-212-0123    lserena@serenagroups.com   
Principal Investigator: Bryan Doner, DO         
Sub-Investigator: Keyur Patel, DO         
Martin Foot and Ankle Recruiting
York, Pennsylvania, United States, 17402
Contact: Beth Mincer    717-757-3537 ext 7332    beth@martinfootandankle.com   
Principal Investigator: Maria Kasper, DPM         
United States, Texas
CHRISTUS Institute for Innovation & Advanced Clinical Care Withdrawn
Corpus Christi, Texas, United States, 78404
Sponsors and Collaborators
SerenaGroup, Inc.
TR Therapeutics, Inc.
Investigators
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Principal Investigator: Thomas Serena, MD SerenaGroup, Inc.

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Responsible Party: SerenaGroup, Inc.
ClinicalTrials.gov Identifier: NCT03154619     History of Changes
Other Study ID Numbers: BG001
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Varicose Ulcer
Venous Insufficiency
Leg Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases