Venous Leg UlcerPhase 2NCT03154619
Efficacy of TR 987, Beta-1,3-1,6-D-glucan, in the Treatment of Chronic Venous Insufficiency Ulcers
A Phase 2 study testing 0.1% TR 987 in people with Venous Leg Ulcer, run by SerenaGroup, Inc. at 9 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- 0.1% TR 987
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 9 sitesUnited States
- Study dates
- Nov 2016to 1 Apr 2021
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Cleveland Foot and Ankle Clinic
Cleveland, Ohio, 44103
The Foot and Ankle Wellness Center
Ford City, Pennsylvania, 16226
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, 16201
New Hope Podiatry Clinic
Los Angeles, California, 90063
Barry University Clinical Research
North Miami Beach, Florida, 33169
Royal Research Corp
Pembroke Pines, Florida, 33027
SerenaGroup Research Institute
Pittsburgh, Pennsylvania, 15222
Martin Foot and Ankle
York, Pennsylvania, 17402
About this study
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.
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.
Read the 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.
- Conditions
- Venous Leg Ulcer
- Being tested
- 0.1% TR 987, Placebo gel
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1% TR 987Drug
Also called Beta glucan
TR 987 0.1%
Placebo gelDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete wound closure
Measured: 12 weeks
Secondary outcomes (4)
Percentage of subjects with complete ulcer healing
Measured: 12 weeks
Change in ulcer size
Measured: 4 weeks
Change in ulcer size
Measured: 12 weeks
Incidence of adverse events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study startNov 2016
- Primary completion4 Apr 2019
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SerenaGroup, Inc.
- Sponsor type
- Research network
- Collaborators
- TR Therapeutics
- Responsible party
- Sponsor
- Investigators
- Thomas Serena, MD, Principal investigator, SerenaGroup, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154619
- Sponsor's protocol ID
- BG001
- Status last verified
- Oct 2020
- First submitted
- 12 May 2017
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03154619
- Acronym / sponsor ID
- BG001
- Conditions
- Venous Leg Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- SerenaGroup, Inc.Research network
- Collaborators
- TR Therapeutics
- Study start
- Nov 2016
- Primary completion
- 4 Apr 2019 (actual)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TR987 | Active comparator | Drug: 0.1% TR 987This 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. |
| Placebo | Placebo comparator | Drug: Placebo gelThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.1% TR 987Also: Beta glucanTR 987 0.1% | Drug | TR987 |
| Placebo gelPlacebo 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. | Drug | Placebo |
Primary outcome
Time to complete wound closure
Time frame: 12 weeks
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Serena, MD principal investigator
SerenaGroup, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.1% TR 987 in people with Venous Leg Ulcer, run by SerenaGroup, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete wound closure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.