Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC

NCT06811909 | Recruiting

• 1 other identifier: BR-AC-VLU-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 23

Brief Summary

This study examines a patient population with a non-healing, non-infected venous leg ulcer (VLU) having adequate arterial perfusion with confirmed venous reflux. It is hypothesized that weekly applications of the human placental allograft BioREtain® Amnion Chorion (BR-AC) applied to a non-healing VLU will result in a higher proportion of wounds showing complete healing within 12 weeks of initiating therapy, compared to standard care alone. This study has a crossover period, where subjects on standard care alone who do not achieve complete healing within 12 weeks of initiating therapy will be allowed to crossover to receive BR-AC over 12 additional weeks, to evaluate if their wound can achieve complete healing.

Conditions

Non-infected Venous Leg Ulcer; Venous Leg Ulcer; Venous Insufficiency; Venous Stasis; Venous Reflux

Outcome Measures

Primary Outcomes (1)

• To determine whether non-ischemic, non-infected VLUs treated with standard care plus BR-AC results in a higher probability of achieving complete wound closure compared to standard care alone.

  Percentage of subjects with complete wound closure over the 12-week treatment period, defined as 100% reepithelialization

  over the 12-week treatment period

Secondary Outcomes (4)

• To compare differences between treatment groups in proportions of wounds with complete wound closure, based on time in days to closure

  at 12 weeks

• To compare differences between treatment groups in percent change in wound area (cm2)

  at 12 weeks

• To determine the total number of applications of BR-AC needed to achieve complete wound closure

  at 12 weeks

• To determine whether subjects that crossover and receive standard care plus BR-AC results in a higher probability of achieving complete wound closure over the 12 additional weeks versus standard care alone

  over an additional 12 weeks

Other Outcomes (2)

• Number of participants that acquire clinical signs and symptoms of infections post-randomization

  over 12-weeks post-randomization

• Proportion of subjects experiencing adverse events, by treatment group

  over the 17-week study period

Study Arms (2)

BR-AC plus Standard Care

EXPERIMENTAL

All subjects in the treatment group will receive sponsor-approved standard of care. Standard of care is defined as: * Sharp debridement, * Wound cleansing with a neutral, non-irritating and non-toxic solution, * Non-adherent wound contact layer followed by an alginate or foam pad to maintain a moist, warm wound bed, and * The UrgoK2™ dual compression system providing around 40 mmHg. Using an appropriate size to cover the entire wound area, BR-AC should be applied directly to the wound surface following sharp debridement. It is recommended that the product be trimmed to fit the area of the wound with sterile scissors before application.

Other: BR-AC

Standard Care

ACTIVE COMPARATOR

All subjects in the control group will receive sponsor-approved standard of care. Standard of care is defined as: * Sharp debridement, * Wound cleansing with a neutral, non-irritating and non-toxic solution, * Non-adherent wound contact layer followed by an alginate or foam pad to maintain a moist, warm wound bed, and * The UrgoK2™ dual compression system providing around 40 mmHg.

Other: Standard Care

Interventions

BR-AC OTHER

BR-AC is an amnion layer, intermediate layer, and chorion layer placental membrane processed together with no separation of the layers. BR-AC is manufactured by BioStem Technologies, Inc. and is processed by the bioREtain method, which, briefly includes initial disinfection, processing with isotonic solutions, dehydration at 37-40°C, and electron beam sterilization.

BR-AC plus Standard Care

Standard Care OTHER

Standard Care is defined as: * Sharp debridement, * Wound cleansing with a neutral, non-irritating and non-toxic solution, * Non-adherent wound contact layer followed by an alginate or foam pad to maintain a moist, warm wound bed, and * The UrgoK2™ dual compression system providing around 40 mmHg.

Standard Care

Eligibility Criteria

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

You may qualify if:

• Patient has signed the informed consent form.
• Male or female patient at least 18 years of age or older, as of the date of the screening visit.
• Has a VLU between the knee and ankle (at or above the malleoli), with a surface area in the range of ≥ 2.0 cm2 and ≤ 20.0 cm2 when measured by the investigator staff at the screening visit using the eKare device post debridement.
• If the subject presents with \> 1, but ≤ 3 VLU on the same leg, the largest ulcer will be selected as the target ulcer.
• If the target ulcer is \< 1cm from another VLU, the ulcers should be traced as a single target ulcer provided at least one of the ulcers is at least 2.0 cm2 in area and the total surface area of the VLUs is ≤ 20.0 cm2.
• Target ulcer involves a full-thickness skin loss, but without exposure of tendon, muscle, or bone.
• Target ulcer duration ≥ 4 weeks but ≤ 52 weeks (12 months).
• Venous insufficiency confirmed by duplex Doppler ultrasound examining valvular or venous incompetence.
• a. Availability of a complete report of a previous examination performed 12 months of screening will be acceptable, and this examination would not be required to be repeated.
• Arterial supply adequacy confirmed by any one of the following:
• Great toe pressure ≥ 50 mm/Hg
• Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.80 ≤ 1.10
• TcPO2 ≥ 40 mmHg from the foot
• Willing to follow all instructions given by the Investigator, return for all visits, and adhere to compression protocols while on the study.

You may not qualify if:

• A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
• Acute Deep Vein Thrombosis (DVT), defined as the first 10 days from onset of symptoms, or any DVT for which compression is considered by the Investigator to be contraindicated.
• Clinical evidence of ulcer bed infection, or infected hardware.
• Documented history of osteomyelitis at the target ulcer location within six (6) months preceding the screening visit.
• Refusal or inability to tolerate compression therapy.
• Pregnant women.
• Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control.
• Hemoglobin A1c (HbA1c) level is \> 12% (108 mmol/mol).
• Current therapy with systemic antibiotics.
• Current therapy with cytotoxic agents.
• Current therapy with chronic (\> 10 days) oral corticosteroids.
• Current therapy with TNFα inhibitors other than Trental® (pentoxifylline).
• Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).
• Has malignancy or history of cancer in the preceding 5 years other than non-melanoma skin cancer.
• Currently on dialysis or planning to start dialysis.

Sponsors & Collaborators

• BioStem Technologies: lead

Study Sites (23)

Site 17

Guntersville, Alabama, 35976, United States

RECRUITING

Site 2b

Castro Valley, California, 94546, United States

RECRUITING

Site 19b

Glendale, California, 91204, United States

RECRUITING

Site 36

Oxnard, California, 93030, United States

RECRUITING

Site 37

Oxnard, California, 93036, United States

RECRUITING

Site 19

Palmdale, California, 93551, United States

RECRUITING

Site 02

San Francisco, California, 94115, United States

RECRUITING

Site 2a

San Francisco, California, 94117, United States

RECRUITING

Site 04

Sylmar, California, 91342, United States

RECRUITING

Site 30

Torrance, California, 90502, United States

RECRUITING

Site 01

Vista, California, 92081, United States

RECRUITING

Site 34

Aventura, Florida, 33180, United States

RECRUITING

Site 27

Coral Gables, Florida, 33134, United States

RECRUITING

Site 20

Deerfield Beach, Florida, 33442, United States

RECRUITING

Site 33

Fort Walton Beach, Florida, 32547, United States

WITHDRAWN

Site 35

Miami, Florida, 33126, United States

RECRUITING

Site 31

Miami, Florida, 33189, United States

TERMINATED

Site 06

O'Fallon, Illinois, 62269, United States

RECRUITING

Site 18

Boston, Massachusetts, 02118, United States

RECRUITING

Site 32

St Louis, Missouri, 63128, United States

RECRUITING

Site 16

Lake Success, New York, 11042, United States

RECRUITING

Site 38

Corpus Christi, Texas, 78414, United States

RECRUITING

Site 03

Fort Worth, Texas, 76104, United States

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer; Venous Insufficiency

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

• Bert Slade, MD

  Independent

  STUDY DIRECTOR

Central Study Contacts

Nick McCoy

CONTACT

2144571996; nmccoy@biostemtech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To reduce bias in the determination of closure, an independent blinded reviewer will review the image obtained from the wound measurement device in each case where the Investigator determines the wound has achieved closure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 6, 2025
• Study Start: February 14, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (23)