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

NCT ID: NCT07335861

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-15
• Study Completion Date: 2026-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care

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

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

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

Hyalomatrix + Standard of Care

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

Group Type: EXPERIMENTAL

Hyalomatrix

Intervention Type: DEVICE

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

Interventions

Hyalomatrix

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

Intervention Type: DEVICE

Standard of Care

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

Intervention Type: OTHER

Other Intervention Names

SOC

Eligibility Criteria

Inclusion Criteria

1. Male or Female, 18 years of age or older

2. Subject has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound

3. 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

4. Subject has a venous leg ulcer with a historical wound measurement showing less than 25% healing within 14 days prior to screening

5. Subject has a venous leg ulcer with screening wound measurement showing less than 25% healing within 14 days prior to randomization

6. Subject has a venous leg ulcer without infection or clinically visible exposed bone

7. Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit

8. 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.

9. Venous Leg Ulcer is being treated with compression therapy for 14 days prior to treatment visit 1

10. Index wound is free of necrotic debris prior to Hyalomatrix application

11. Female subjects of childbearing potential having a negative pregnancy test prior to randomization

12. 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.

13. Subject is able and willing to follow the protocol requirements

14. Subject had signed informed consent

15. If 2 or more wounds are present, the wounds must be separated by at least 2 cm

Exclusion Criteria

1. Subject does not have a diagnosis of venous leg ulcer or venous insufficiency with a wound located on the lower extremity

2. Subject has a known life expectancy of <1 year

3. Subject is unable to comply with protocol treatment

4. 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

5. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound

6. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator

7. Known contraindications to tissue-engineered allograft

8. Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P interfering with wound treatment and/or healing.

9. Subject is pregnant or breastfeeding

10. 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

11. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization

12. Venous leg ulcer with active infection

13. Wound depth with visible exposed bone

14. HBOT within 14 days prior to randomization

15. Revascularization surgery on the index wound leg within 30 days of screening phase

16. Index wound suspicious of neoplasm in the opinion of the principal investigator

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NuScience Medical Biologics, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angelina Ferguson, DNP

Role: STUDY_DIRECTOR

SygNola, LLC

Central Contacts

Sarah Moore

Role: CONTACT

sarah.moore@sygnola.com

985-629-4013

Angelina Ferguson

Role: CONTACT

dr.aferguson@sygnola.com

985-629-4013

Other Identifiers

HALO

Identifier Type: -

Identifier Source: org_study_id