Is NCT06568627 recruiting in Los Angeles, CA?

Yes, NCT06568627 is currently recruiting participants at its Los Angeles, CA location. This venous leg ulcer clinical trial is actively enrolling qualified participants.

How do I join the venous leg ulcer clinical trial in Los Angeles?

To join this clinical trial in Los Angeles, 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 Los Angeles 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.

Venous Leg Ulcer Clinical Trial in Los Angeles, CA

Who Can Participate

Inclusion Criteria

Men or women, older than 18 years of age,

Patients with a VLU (determined by medical history, physical examination, and a documented ultrasound scan demonstrating venous insufficiency),

Wound is present for at least 4 weeks but no longer than 18 months,

The adherent necrotic/thick slough/fibrin non-viable tissue area, assessed following wound cleansing with wet gauze and either sterile saline or water and mild soap, at least 50% of the wound area (assessed by clinical evaluation),

Target wound surface area is in the range of 2-25 cm2 (assessed by eKare inSightTM),

Patient understands the nature of the procedure, is able to adhere to the protocol regimen, and provides a written informed consent prior to any study procedure.

Exclusion Criteria

Wound size that has decreased by \> 20% after 7 (+3/-1) days of the screening period,

Patients with more than one leg ulcer, on the leg of the target wound, with an area greater than or equal to 2 cm2, that are between 2cm and 5cm away from the edge of the target wound,

Signs of clinical infection of the wound or peri-wound, including purulent discharge, deep-tissue abscess, erysipelas, cellulitis, etc.,

Severely damaged skin (e.g. abrasion, erosion, exfoliation) extending \>2 cm around the wound's edge,

Presence of gangrene, signs of systemic infection, sepsis, or osteomyelitis during screening phase,

Clinical suspicion of skin cancer (e.g., basal cell carcinoma (BCC), squamous cell carcinoma (SCC), melanoma, or sarcoma), near the target wound, which was not ruled out by biopsy,

Patients with skin disorders unrelated to the wound that are presented adjacent to the wound,

Patients suffering from chronic skin disorders (Idiopathic Pruritus, Psoriasis, Panniculitis, Pyoderma gangrenosum, etc.) that might deteriorate as a result of local trauma or debridement,

Wound has sinus tracts or tunnels extending under healthy tissue or penetrating into periosteum, fascia or bone,

Patients with primary lymphatic edema (Lymphedema),

A significant decrease in the arterial blood flow of the extremity, as demonstrated by either Toe-Brachial Index (TBI) ≤ 0.50, Ankle-Brachial Index (ABI) ≤ 0.70, Skin Perfusion Pressure (SPP) ≤ 40 mmHg, Transcutaneous oximetry (TCOM) ≤ 40 mmHg, or lack of bi-phasic or tri-phasic doppler wave forms,

Patients with pre-enrollment wounds which are covered by eschar heavily saturated with iodine or by silver sulfadiazine (SSD) pseudoeschar (i.e., pseudoeschar as a result of SSD treatment),

History of allergy or atopic disease or a known sensitivity to pineapples, bromelain, papaya or papain, as well as known sensitivity to latex proteins (known as latex-fruit syndrome), bee venom or olive tree pollen,

Patients with poor nutritional status: albumin \< 2.5 g/dl; poorly controlled diabetes mellitus (HbA1c \> 12%); anemia (hemoglobin\<8 g/dL), leukocyte count \< 3,000/μl or \>15000/μl; neutrophil count ≤1000/μl; platelets \<100,000/μl, abnormal liver function (AST, ALT\>2 x upper limit of normal range), renal failure (Cr \> 2.5 mg/dl or eGFR \< 30ml/min /1.73m2), BMI\>48,

INR\>2 or PTT \> x 2 ULN (unless the patient receives coumarin derivatives anticoagulants (e.g. warfarin), and the INR and PTT levels are in their required levels and are stable),

Patients undergoing renal or peritoneal dialysis,

Any condition that would preclude safe participation in the study, e.g., significant or unstable cardiac, vascular, pulmonary, liver, hematological, immunological, neoplastic disease, active COVID-19 or any immediate life-threatening condition,

Recent history or concurrent acute injury or disease that might compromise the patient's welfare, according to investigator discretion,

The patient is currently receiving, has received within three months prior to enrollment, or is planned to receive during trial period, any medications or treatments at doses known to impair the wound healing processes. These include chronic systemic steroid intake5 associated with topical skin changes (i.e. thin, fragile skin with multiple hematomas or a history of laceration), immuno-suppressive drugs, immunomodulating medications, chemotherapy, and radiation therapy. Low and intermittent doses that the investigator determines as not clinically significant for wound healing, may be permitted, provided that this determination is based on appropriate clinical judgment and is documented accordingly,

Patients treated with Pentoxifylline within 2 weeks prior to screening,

Venous ablation performed within the past month in an area adjacent to the target wound,

Mentally incapacitated incompetent adults who are incapable of giving legal consent (e.g., dementia, psychiatric patients, etc.),

Concurrent use of non-approved drugs or alcohol abuse,

Pregnant women (positive pregnancy test) or nursing mothers,

Exposure to investigational intervention within one month prior to enrollment, or anticipated participation in another investigational drug trial or other intervention trial, while enrolled in the study.

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 Los Angeles?

Yes, this clinical trial (NCT06568627) has an active research site in Los Angeles, 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.

Venous Leg Ulcer Treatment Options in Los Angeles, CA

If you're searching for venous leg ulcer treatment options in Los Angeles, CA, this clinical trial (NCT06568627) 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 Los Angeles research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced 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.

Venous Leg Ulcer Clinical Trial in Los Angeles, CA

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About This Venous Leg Ulcer Study in Los Angeles