Venous Leg UlcerNCT07335861
Evaluation of the Efficacy of Hyalomatrix® in the Healing of Chronic Venous Leg Ulcers
A study testing Hyalomatrix in people with Venous Leg Ulcer and Chronic Wounds, run by NuScience Medical Biologics, LLC at 4 sites in United States.
Trial summary
This is a randomized controlled trial evaluating the efficacy of HYALOMATRIX in conjunction with standard of care vs. standard of care alone in treating venous leg ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer, Chronic Wounds
- What is being tested?
- Hyalomatrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 May 2026to 31 Jan 2027
- Phase
- Interventional
- 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
- Male or Female, 18 years of age or older
- Subject has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound
- Subject has a venous leg ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC
- Subject has a venous leg ulcer with a historical wound measurement showing less than 25% healing within 14 days prior to screening
- Subject has a venous leg ulcer with screening wound measurement showing less than 25% healing within 14 days prior to randomization
- Subject has a venous leg ulcer without infection or clinically visible exposed bone
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- Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit
- Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of >0.7 and <1.3, or TBI of >0.6 within 30 days prior to informed consent OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to the first treatment visit.
- Venous Leg Ulcer is being treated with compression therapy for 14 days prior to treatment visit 1
- Index wound is free of necrotic debris prior to Hyalomatrix application
- Female subjects of childbearing potential having a negative pregnancy test prior to randomization
- Index wound is free of infection prior to randomization and during screening phase noted with the NERDS Assessment. Infection must be adequately treated and controlled prior to randomization.
- Subject is able and willing to follow the protocol requirements
- Subject had signed informed consent
- If 2 or more wounds are present, the wounds must be separated by at least 2 cm
Who cannot join
- Subject does not have a diagnosis of venous leg ulcer or venous insufficiency with a wound located on the lower extremity
- Subject has a known life expectancy of <1 year
- Subject is unable to comply with protocol treatment
- Subject has comorbid conditions that may compromise subject safety or wound healing in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders
- Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound
- Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
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- Known contraindications to tissue-engineered allograft
- Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P interfering with wound treatment and/or healing.
- Subject is pregnant or breastfeeding
- Subject with history of immunosuppressant treatment (systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the wound surface for >2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study
- Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization
- Venous leg ulcer with active infection
- Wound depth with visible exposed bone
- HBOT within 14 days prior to randomization
- Revascularization surgery on the index wound leg within 30 days of screening phase
- Index wound suspicious of neoplasm in the opinion of the principal investigator
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
MedCentris of Alexandria
Alexandria, Louisiana, 71301
Laura Whittington, laura.whittington@medcentris.com
Rachel Ward, NP
- Recruiting
MedCentris of Cleveland
Cleveland, Mississippi, 38732
Chance Lewis, MS, joshua.lewis@medcentirs.com
Shauna Allen, NP
- Recruiting
MedCentris of Pineville
Pineville, Louisiana, 71360
Laura Whittington, laura.whittington@medcentris.com
Rachel Ward, NP
- Recruiting
MedCentris of Vidaila
Vidalia, Louisiana, 71373
Keatrice Williams, keatrice.williams@medcentris.com
Shanda Jackson, NP
About this study
Official title: Evaluation of the Efficacy of Hyalomatrix® in the Healing of Chronic Venous Leg Ulcers: A Randomized Controlled Multicenter Crossover Trial
This is a randomized controlled trial evaluating the efficacy of HYALOMATRIX in conjunction with standard of care vs. standard of care alone in treating venous leg ulcers.
Read the detailed description
This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet the study requirements during screening will be randomly assigned to one of two groups: either standard of care (SOC) alone, or SOC plus Hyalomatrix. The study includes a crossover component for subjects in the SOC arm. At treatment visit 13 (approximately 84 days post-randomization), SOC arm subjects not having achieved complete wound closure, and still meeting the inclusion/exclusion criteria, are eligible to crossover to the IP arm (SOC plus Hyalomatrix). Crossover subjects will begin IP arm treatment with weekly Hyalomatrix applications for up to 12 treatment visits. The subject will continue follow-up per the original schedule. As this is a post-marketing study, it will gather information regarding the efficacy of treatment while also supporting insurance reimbursement decisions.
- Conditions
- Venous Leg Ulcer, Chronic Wounds
- Being tested
- Hyalomatrix, Standard of Care
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyalomatrixDevice
Hyalomatrix is a hyaluronic acid-based wound dressing designed for advanced wound therapy.
Standard of CareOther
Also called SOC
Wound cleansing, Sharps debridement, Dressing for moisture balance, Compression therapy
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Wound cleansing, sharps debridement, dressing for moisture balance, and compression therapy Receives: Other: Standard of Care |
| Hyalomatrix + Standard of Care | Experimental | Wound cleansing, sharps debridement, Hyalomatrix application, dressing for moisture balance, compression therapy Receives: Device: Hyalomatrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Wound Closure
The primary endpoint will be the percentage of target wounds that achieve complete wound closure within 12 weeks.
Measured: 1-12 weeks
Secondary outcomes (2)
Weekly Percentage Area Reduction
The percentage reduction in wound area from 1-12 weeks will be measured weekly using digital photographic planimetry and physical examination.
Measured: 1-12 weeks
Pain Assessment
Change in pain associated with the target wound will be assessed using the Numeric Pain Rating Scale throughout the study. Numeric Rating on a scale of 0-10. o is No pain and 10 is the worst possible pain.
Measured: 1-14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start14 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The subject will be randomized to one of the following treatments: Standard of care (SOC) combined with Hyalomatrix or SOC alone.
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NuScience Medical Biologics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angelina Ferguson, DNP, Study director, SygNola, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335861
- Sponsor's protocol ID
- HALO
- Status last verified
- Jun 2026
- First submitted
- 9 Jan 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Hyalomatrix® in the Healing of Chronic Venous Leg Ulcers: A Randomized Controlled Multicenter Crossover Trial
- ClinicalTrials.gov ID
- NCT07335861
- Acronym / sponsor ID
- HALO
- Conditions
- Venous Leg Ulcer, Chronic Wounds
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- NuScience Medical Biologics, LLCIndustry (pharma, biotech, devices)
- Study start
- 14 May 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 13 Jan 2026 (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.
This is a randomized controlled trial evaluating the efficacy of HYALOMATRIX in conjunction with standard of care vs. standard of care alone in treating venous leg ulcers.
Detailed description
This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet the study requirements during screening will be randomly assigned to one of two groups: either standard of care (SOC) alone, or SOC plus Hyalomatrix. The study includes a crossover component for subjects in the SOC arm. At treatment visit 13 (approximately 84 days post-randomization), SOC arm subjects not having achieved complete wound closure, and still meeting the inclusion/exclusion criteria, are eligible to crossover to the IP arm (SOC plus Hyalomatrix). Crossover subjects will begin IP arm treatment with weekly Hyalomatrix applications for up to 12 treatment visits. The subject will continue follow-up per the original schedule. As this is a post-marketing study, it will gather information regarding the efficacy of treatment while also supporting insurance reimbursement decisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The subject will be randomized to one of the following treatments: Standard of care (SOC) combined with Hyalomatrix or SOC alone.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of CareWound cleansing, sharps debridement, dressing for moisture balance, and compression therapy |
| Hyalomatrix + Standard of Care | Experimental | Device: HyalomatrixWound cleansing, sharps debridement, Hyalomatrix application, dressing for moisture balance, compression therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or Female, 18 years of age or older
- Subject has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound
- Subject has a venous leg ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC
- Subject has a venous leg ulcer with a historical wound measurement showing less than 25% healing within 14 days prior to screening
- Subject has a venous leg ulcer with screening wound measurement showing less than 25% healing within 14 days prior to randomization
Key exclusion criteria (16 listed)
- Subject does not have a diagnosis of venous leg ulcer or venous insufficiency with a wound located on the lower extremity
- Subject has a known life expectancy of <1 year
- Subject is unable to comply with protocol treatment
- Subject has comorbid conditions that may compromise subject safety or wound healing in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders
- Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound
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 |
|---|---|---|
| HyalomatrixHyalomatrix is a hyaluronic acid-based wound dressing designed for advanced wound therapy. | Device | Hyalomatrix + Standard of Care |
| Standard of CareAlso: SOCWound cleansing, Sharps debridement, Dressing for moisture balance, Compression therapy | Other | Standard of Care |
Primary outcome
Complete Wound Closure
Time frame: 1-12 weeks
The primary endpoint will be the percentage of target wounds that achieve complete wound closure within 12 weeks.
2 secondary outcomes
Weekly Percentage Area Reduction
Time frame: 1-12 weeks
Pain Assessment
Time frame: 1-14 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 30 Jun 2026.
- 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.
Angelina Ferguson, DNP study director
SygNola, LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyalomatrix in people with Venous Leg Ulcer and Chronic Wounds, run by NuScience Medical Biologics, LLC at 4 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 15 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Sarah Moore (985-629-4013, sarah.moore@sygnola.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Wound Closure (time frame: 1-12 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 30 Jun 2026.