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

Launched by BIOSTEM TECHNOLOGIES · Feb 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for people with non-healing venous leg ulcers, which are painful sores on the legs that haven't been able to heal properly. The researchers want to find out if applying a special skin product called BR-AC (AmnioWrap2®) once a week, in addition to standard care, can help these ulcers heal faster than just using standard care alone. If participants don't see improvement in their ulcers after 12 weeks, they will have the chance to switch to the BR-AC treatment for another 12 weeks.

To join the study, participants must be at least 18 years old and have a specific type of ulcer located between the knee and ankle. The ulcer needs to be at least 2 square centimeters in size and have been present for at least 4 weeks. Additionally, participants should not have any other serious conditions that could interfere with the treatment, like infections or certain medical treatments. Throughout the trial, participants will have regular check-ups to monitor their progress and must follow specific care instructions. This study is currently looking for volunteers who meet these criteria and want to help find better ways to treat these difficult wounds.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• • 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.
• 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.
• Exclusion Criteria:
• • 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.