Is NCT06811909 recruiting in Oxnard, CA?

Yes, NCT06811909 is currently recruiting participants at its Oxnard, CA location. This non-infected venous leg ulcer clinical trial is actively enrolling qualified participants.

How do I join the non-infected venous leg ulcer clinical trial in Oxnard?

To join this clinical trial in Oxnard, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Oxnard clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Non-infected Venous Leg Ulcer Clinical Trial in Oxnard, CA

About This Non-infected Venous Leg Ulcer Study in Oxnard

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.

Sponsor: BioStem Technologies

Who Can Participate

Inclusion Criteria

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.

Exclusion Criteria

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.

Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening.

Therapy of the target ulcer with other birth tissue products, autologous skin graft, Apligraf®, or Dermagraft® within 30 days preceding the screening visit.

Therapy of the target ulcer with topical growth factors within thirty (30) days preceding the screening visit.

Any previous use of Vendaje®, Vendaje AC®, AmnioWrap2® applied to the target ulcer.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Oxnard?

Yes, this clinical trial (NCT06811909) has an active research site in Oxnard, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Non-infected Venous Leg Ulcer Treatment Options in Oxnard, CA

If you're searching for non-infected venous leg ulcer treatment options in Oxnard, CA, this clinical trial (NCT06811909) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Oxnard research site is actively enrolling participants for this clinical trial. You'll receive care from experienced non-infected venous leg ulcer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all non-infected venous leg ulcer clinical trials near you to find additional studies recruiting in your area.

Non-infected Venous Leg Ulcer Clinical Trial in Oxnard, CA

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