Is NCT07209358 recruiting in Santa Ana, CA?

Yes, NCT07209358 is currently recruiting participants at its Santa Ana, CA location. This wound heal clinical trial is actively enrolling qualified participants.

How do I join the wound heal clinical trial in Santa Ana?

To join this clinical trial in Santa Ana, 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 Santa Ana 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.

Wound Heal Clinical Trial in Santa Ana, CA

Who Can Participate

Inclusion Criteria

Participants at least 18 years old and willing to participate in all procedures and follow-up evaluations necessary to complete the study.

The participant must have an index ulcer meeting the following characteristics:

Non-healing DFU defined as; at least 4 weeks prior to enrolment the ulcer has failed to progress on a healing trajectory.

Full-thickness wound; defined as Wagner Diabetic Foot Ulcer Grade 1 - superficial ulcer of skin or subcutaneous tissue.

Located on the anatomical foot; defined as distal to the medial or lateral malleolus.

Presents with or without clinical signs of superficial infection. Infection is defined using International Working Group of the Diabetic Foot (IWGDF) PEDIS classification and for the purpose of inclusion infections must be PEDIS grade 1 (Mild); Infected: At least two of these items are present: Local swelling or induration Erythema \>0.5 but \<2 cm2 around the wound, Local tenderness or pain, Local increased warmth, Purulent discharge.

Ulcer duration at randomization must be present for ≥1 month but less than \<24 months in duration.

Post-debridement wound area is ≥0.1 cm2 and ≤25 cm2.

If two or more ulcers either mono or bilateral are present, the index ulcer must additionally be:

The ulcer with the largest wound area, as long as it meets all other criteria.

≥3cm distance from any other ulcer on the affected limb

Known history of type 1 or type 2 diabetes (confirmed by the subject's medical history).

HgbA1c \<12% (NGSP) OR 108 mmol/mol (IFCC) OR average blood glucose 298 mg/DL.

Participant has adequate circulation to the affected extremity as defined by Wound, Ischemia, foot Infection (WIfI) Ischemia grades 0-1 (no PAD to Mild PAD).

Participants are required to have either.

Ankle-Brachial Index (ABI) by Doppler: ≥0.6 OR Toe-Brachial Index (TBI) ≥ 0.5

OR Dorsum transcutaneous oxygen test (TcPO2): \>40 mm/Hg

Exclusion Criteria

Participants with wounds that have any of the following characteristics:

Wagner Grade 2 - ulcers extend into tendon, bone, or capsule

Grade 3 - deep ulcer with osteomyelitis, or abscess

Grade 4 - partial foot gangrene

Grade 5 - whole foot gangrene

Infections that are classified as:

PEDIS 3 (Moderate): Infection with no systemic manifestations and involving: Erythema extending ≥2 cm2 from the wound margin, and/or tissue deeper than skin and subcutaneous tissues (e.g., tendon, muscle, joint, and bone).

PEDIS 4 (Severe): All of the above in PEDIS 3 plus manifestations (of the systemic inflammatory response syndrome \[SIRS\]).

In addition, any diabetic foot infections with; Confirmed underlying bone involvement (osteomyelitis) based on; imaging (plain X-ray, CT or MRI), clinical examination (exposed bone or positive probe to bone test) or culture/histopathology of a bone specimen

OR Cellulitis/lymphangitis/soft tissue gas or necrotizing fasciitis originating from the wound site.

Tunnelling, Cavity or undermining wounds.

Known or suspected local skin malignancy at the site of the ulcer.

A wound that is actively bleeding. This does not exclude enrollment once active bleeding has stopped (hemostasis).

Gross Foot deformities that would interfere with proper off-loading or proper wound healing i.e. non-active charcot foot, rocker bottom foot, gross digital deformities.

Active Charcot deformity.

Wound duration \>2 years.

Participants receiving any of the following prior therapies. In the last 30 days:

Has required systemic corticosteroids \>10mg/kg/day OR

Participant has required Chemoradiation (chemotherapy and/or radiation therapy) to treat cancer and is immunocompromised OR

Participant is anticipated to require such medications during the study period.

Study ulcer treatment with any advanced therapy, including, biomedical or topical growth factors, tissue engineered materials (e.g., Apligraf or Dermagraft), sterilized placental allografts (EpiFix, NovaFix, etc.), or other scaffold materials (e.g., OASIS® Wound Matrix, MatriStem Wound Matrix).

Has undergone any amputation to the affected leg.

Known hypersensitivity to constituents of the product.

Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of, or compliance with the study protocol in the judgement of the Investigator.

Women of childbearing age (women aged \<55 years who have not undergone menopause) who are:

Pregnant at time of enrolment

Breast-feeding

Concurrent enrolment in any other 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 Santa Ana?

Yes, this clinical trial (NCT07209358) has an active research site in Santa Ana, 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.

Wound Heal Treatment Options in Santa Ana, CA

If you're searching for wound heal treatment options in Santa Ana, CA, this clinical trial (NCT07209358) 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 Santa Ana research site is actively enrolling participants for this clinical trial. You'll receive care from experienced wound heal 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 wound heal clinical trials near you to find additional studies recruiting in your area.

Wound Heal Clinical Trial in Santa Ana, CA

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