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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Venous Leg Ulcer; Chronic Wounds
• Intervention / Treatment: Other: Standard of Care; Device: Hyalomatrix

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 Type: Interventional
• Enrollment (Estimated): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Moore; Phone Number: 985-629-4013; Email: sarah.moore@sygnola.com
• Study Contact Backup: Name: Angelina Ferguson; Phone Number: 985-629-4013; Email: dr.aferguson@sygnola.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; Wound cleansing, sharps debridement, dressing for moisture balance, and compression therapy	Other: Standard of Care; Wound cleansing, Sharps debridement, Dressing for moisture balance, Compression therapy; Other Names: SOC
Experimental: Hyalomatrix + Standard of Care; Wound cleansing, sharps debridement, Hyalomatrix application, dressing for moisture balance, compression therapy	Device: Hyalomatrix; Hyalomatrix is a hyaluronic acid-based wound dressing designed for advanced wound therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1-14 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Closure	Average number of grafts/weeks used to achieve wound closure	1-12 weeks
Follow-Up Closure	Number of wounds that re-opened during the 2-week follow-up	2 weeks
Adverse Events and Serious Adverse Events	The number and nature of adverse events (AEs) and serious adverse events (SAEs) occurring during the study will be tracked and reported.	1-12 weeks

Collaborators and Investigators

• Sponsor: NuScience Medical Biologics, LLC
• Investigators: Study Director: Angelina Ferguson, DNP, SygNola, LLC

Study record dates

Study Major Dates

• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Skin and Connective Tissue Diseases; Varicose Ulcer; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: HALO (Akashi Therapeutics)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes