Evaluation of the Efficacy of Hyalomatrix® in the Healing of Chronic Venous Leg Ulcers

NCT07335861 | Not Yet Recruiting FDA Device

• 1 other identifier: HALO
• Study Type: interventional
• Target: 122
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Venous Leg Ulcer; Chronic Wounds

Outcome Measures

Primary Outcomes (1)

• Complete Wound Closure

  The primary endpoint will be the percentage of target wounds that achieve complete wound closure within 12 weeks.

  1-12 weeks

Secondary Outcomes (2)

• Weekly Percentage Area Reduction

  1-12 weeks

• Pain Assessment

  1-14 weeks

Other Outcomes (3)

• Time to Closure

  1-12 weeks

• Follow-Up Closure

  2 weeks

• Adverse Events and Serious Adverse Events

  1-12 weeks

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Wound cleansing, sharps debridement, dressing for moisture balance, and compression therapy

Other: Standard of Care

Hyalomatrix + Standard of Care

EXPERIMENTAL

Wound cleansing, sharps debridement, Hyalomatrix application, dressing for moisture balance, compression therapy

Device: Hyalomatrix

Interventions

Hyalomatrix DEVICE

Hyalomatrix is a hyaluronic acid-based wound dressing designed for advanced wound therapy.

Hyalomatrix + Standard of Care

Standard of Care OTHER

Wound cleansing, Sharps debridement, Dressing for moisture balance, Compression therapy

Also known as: SOC

Standard of Care

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• NuScience Medical Biologics, LLC: lead

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Angelina Ferguson, DNP

  SygNola, LLC

  STUDY DIRECTOR

Central Study Contacts

Sarah Moore

CONTACT

985-629-4013; sarah.moore@sygnola.com

Angelina Ferguson

CONTACT

985-629-4013; dr.aferguson@sygnola.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The subject will be randomized to one of the following treatments: Standard of care (SOC) combined with Hyalomatrix or SOC alone.

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 13, 2026
• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share