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

Venous Leg Ulcer Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03154619
• Other study ID #: BG001
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 2016
• Est. completion date: April 1, 2021

Study information

• Verified date: October 2020
• Source: SerenaGroup, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: April 1, 2021
• Est. primary completion date: April 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Insufficiency
• Venous Leg Ulcer

Intervention

Drug:
• 0.1% TR 987
TR 987 0.1%
• 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.

Locations

Country	Name	City	State
United States	Deborah Heart and Lung Center	Browns Mills	New Jersey
United States	Cleveland Foot and Ankle Clinic	Cleveland	Ohio
United States	The Foot and Ankle Wellness Center	Ford City	Pennsylvania
United States	Armstrong County Memorial Hospital	Kittanning	Pennsylvania
United States	New Hope Podiatry Clinic	Los Angeles	California
United States	Barry University Clinical Research	North Miami Beach	Florida
United States	Royal Research Corp	Pembroke Pines	Florida
United States	SerenaGroup Research Institute	Pittsburgh	Pennsylvania
United States	Martin Foot and Ankle	York	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
SerenaGroup, Inc.	TR Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to complete wound closure		12 weeks
Secondary	Percentage of subjects with complete ulcer healing		12 weeks
Secondary	Change in ulcer size		4 weeks
Secondary	Change in ulcer size		12 weeks
Secondary	Incidence of adverse events		12 weeks