RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Prospective, Multicenter, Randomized, Controlled Trial of Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC

Quick Facts

Study Start:2025-02-14

Study Completion:2026-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06811909

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patient has signed the informed consent form. 2. Male or female patient at least 18 years of age or older, as of the date of the screening visit. 3. 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. 1. If the subject presents with \> 1, but ≤ 3 VLU on the same leg, the largest ulcer will be selected as the target ulcer. 2. 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. 4. Target ulcer involves a full-thickness skin loss, but without exposure of tendon, muscle, or bone. 5. Target ulcer duration ≥ 4 weeks but ≤ 52 weeks (12 months). 6. Venous insufficiency confirmed by duplex Doppler ultrasound examining valvular or venous incompetence. 7. Arterial supply adequacy confirmed by any one of the following: 1. Great toe pressure ≥ 50 mm/Hg 2. Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.80 ≤ 1.10 3. TcPO2 ≥ 40 mmHg from the foot 8. Willing to follow all instructions given by the Investigator, return for all visits, and adhere to compression protocols while on the study.	1. A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic). 2. 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. 3. Clinical evidence of ulcer bed infection, or infected hardware. 4. Documented history of osteomyelitis at the target ulcer location within six (6) months preceding the screening visit. 5. Refusal or inability to tolerate compression therapy. 6. Pregnant women. 7. Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control. 8. Hemoglobin A1c (HbA1c) level is \> 12% (108 mmol/mol). 9. Current therapy with systemic antibiotics. 10. Current therapy with cytotoxic agents. 11. Current therapy with chronic (\> 10 days) oral corticosteroids. 12. Current therapy with TNFα inhibitors other than Trental® (pentoxifylline). 13. Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS). 14. Has malignancy or history of cancer in the preceding 5 years other than non-melanoma skin cancer. 15. Currently on dialysis or planning to start dialysis. 16. Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening. 17. Therapy of the target ulcer with other birth tissue products, autologous skin graft, Apligraf®, or Dermagraft® within 30 days preceding the screening visit. 18. Therapy of the target ulcer with topical growth factors within thirty (30) days preceding the screening visit. 19. Any previous use of Vendaje®, Vendaje AC®, AmnioWrap2® applied to the target ulcer.

Inclusion Criteria

Exclusion Criteria

1. Patient has signed the informed consent form.
2. Male or female patient at least 18 years of age or older, as of the date of the screening visit.
3. 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.
1. If the subject presents with \> 1, but ≤ 3 VLU on the same leg, the largest ulcer will be selected as the target ulcer.
2. 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.
4. Target ulcer involves a full-thickness skin loss, but without exposure of tendon, muscle, or bone.
5. Target ulcer duration ≥ 4 weeks but ≤ 52 weeks (12 months).
6. Venous insufficiency confirmed by duplex Doppler ultrasound examining valvular or venous incompetence.
7. Arterial supply adequacy confirmed by any one of the following:
1. Great toe pressure ≥ 50 mm/Hg
2. Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.80 ≤ 1.10
3. TcPO2 ≥ 40 mmHg from the foot
8. Willing to follow all instructions given by the Investigator, return for all visits, and adhere to compression protocols while on the study.

1. A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
2. 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.
3. Clinical evidence of ulcer bed infection, or infected hardware.
4. Documented history of osteomyelitis at the target ulcer location within six (6) months preceding the screening visit.
5. Refusal or inability to tolerate compression therapy.
6. Pregnant women.
7. Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control.
8. Hemoglobin A1c (HbA1c) level is \> 12% (108 mmol/mol).
9. Current therapy with systemic antibiotics.
10. Current therapy with cytotoxic agents.
11. Current therapy with chronic (\> 10 days) oral corticosteroids.
12. Current therapy with TNFα inhibitors other than Trental® (pentoxifylline).
13. Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).
14. Has malignancy or history of cancer in the preceding 5 years other than non-melanoma skin cancer.
15. Currently on dialysis or planning to start dialysis.
16. Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening.
17. Therapy of the target ulcer with other birth tissue products, autologous skin graft, Apligraf®, or Dermagraft® within 30 days preceding the screening visit.
18. Therapy of the target ulcer with topical growth factors within thirty (30) days preceding the screening visit.
19. Any previous use of Vendaje®, Vendaje AC®, AmnioWrap2® applied to the target ulcer.

Contacts and Locations

Study Contact

Nick McCoy

CONTACT

2144571996

nmccoy@biostemtech.com

Principal Investigator

Jessica H, MD

STUDY_DIRECTOR

Independent

Study Locations (Sites)

Site 17

Guntersville, Alabama, 35976

United States

Site 2b

Castro Valley, California, 94546

United States

Site 19

Palmdale, California, 93551

United States

Site 02

San Francisco, California, 94115

United States

Site 2a

San Francisco, California, 94117

United States

Site 04

Sylmar, California, 91342

United States

Site 30

Torrance, California, 90502

United States

Site 01

Vista, California, 92081

United States

Site 20

Deerfield Beach, Florida, 33442

United States

Site 18

Boston, Massachusetts, 02118

United States

Site 16

Lake Success, New York, 11042

United States

Site 15

Chapel Hill, North Carolina, 27599

United States

Site 03

Fort Worth, Texas, 76104

United States

Collaborators and Investigators

Sponsor: BioStem Technologies

Jessica H, MD, STUDY_DIRECTOR, Independent

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-14

Study Completion Date2026-10

Study Record Updates

Study Start Date2025-02-14

Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

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