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

NCT03154619 | Active Not Recruiting Phase 2

• 1 other identifier: BG001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 9

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.

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• Time to complete wound closure

  12 weeks

Secondary Outcomes (4)

• Percentage of subjects with complete ulcer healing

  12 weeks

• Change in ulcer size

  4 weeks

• Change in ulcer size

  12 weeks

• Incidence of adverse events

  12 weeks

Study Arms (2)

TR987

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

0.1% TR 987 DRUG

TR 987 0.1%

Also known as: Beta glucan

TR987

Placebo gel DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is at least 18 years old
• Female subjects are not pregnant or breastfeeding.
• 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.
• 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.
• Study ulcer has a clean, granulating base with minimal adherent slough at the randomization visit.
• 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.
• 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.
• Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
• Patient understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
• Patient has read and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.

You may not qualify if:

• Study ulcer deemed by the Investigator to be caused by a medical condition other than venous insufficiency.
• Study ulcer exhibits clinical signs and symptoms of infection.
• Study ulcer requires enzymatic debridement during the study.
• Study ulcer has undergone 12 or more months of continuous high-strength compression therapy over its duration.
• Study ulcer is less than 2.0 cm2 or greater than 20.0 cm2.
• Study ulcer extends more than 50% below the malleolus.
• Study ulcer is treated with a topical antibiotic during the screening phase.
• 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.
• Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the course of the trial.
• History of radiation at the study ulcer site.
• Study ulcer decreases in area by 30% or more during the 14 days screening period.
• Subjects who are unable to understand the aims and objectives of the trial or has a known history of poor adherence with medical treatment.
• Presence of any condition(s) that seriously compromises the subject's ability to complete this study.
• 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.

Sponsors & Collaborators

• SerenaGroup, Inc.: lead
• TR Therapeutics: collaborator

Study Sites (9)

New Hope Podiatry Clinic

Los Angeles, California, 90063, United States

Location

Barry University Clinical Research

North Miami Beach, Florida, 33169, United States

Location

Royal Research Corp

Pembroke Pines, Florida, 33027, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Cleveland Foot and Ankle Clinic

Cleveland, Ohio, 44103, United States

Location

The Foot and Ankle Wellness Center

Ford City, Pennsylvania, 16226, United States

Location

Armstrong County Memorial Hospital

Kittanning, Pennsylvania, 16201, United States

Location

SerenaGroup Research Institute

Pittsburgh, Pennsylvania, 15222, United States

Location

Martin Foot and Ankle

York, Pennsylvania, 17402, United States

Location

MeSH Terms

Conditions

Varicose Ulcer

Interventions

beta-Glucans

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates

Study Officials

• Thomas Serena, MD

  SerenaGroup, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 16, 2017
• Study Start: November 1, 2016
• Primary Completion: April 4, 2019
• Study Completion: April 1, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)