Thousand Oaks, CANCT06550596Now EnrollingIRB Ready

Diabetic Foot Clinical Trial in Thousand Oaks, CA

Access cutting-edge diabetic foot treatment through this clinical trial at a research site in Thousand Oaks. Study-provided care at no cost to qualified participants.

Sponsored by Axolotl Biologix

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Expert Care in Thousand Oaks

Access diabetic foot specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related diabetic foot treatment provided free

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Check if you qualify for this diabetic foot clinical trial in Thousand Oaks, CA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Thousand Oaks

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Thousand Oaks site if eligible
  4. 4Begin participation

About This Diabetic Foot Study in Thousand Oaks

The purpose of this study is to evaluate the efficacy of dehydrated human amnion membrane (dhAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).

Sponsor: Axolotl Biologix

Who Can Participate

Inclusion Criteria

Subjects must be at least 18 years of age or older.
Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 5.0 cm2 measured post debridement.
The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
The target ulcer must be Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.
The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
ABI ≥ 0.7 and ≤ 1.3;
TCOM ≥ 40 mmHg;
PVR: biphasic.
If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and

Exclusion Criteria

will be designated as the target ulcer.
The subject must consent to using the prescribed offloading method for the duration of the study.
The subject must agree to attend the weekly study visits required by the protocol.
The subject must be willing and able to participate in the informed consent process. Exclusion Criteria:
A subject known to have a life expectancy of \< 6 months is excluded.
The subject is excluded if the target ulcer is not secondary to diabetes.
If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.
A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
The subject is excluded if the surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). Photographic planimetry is not required for measurements taken during the historical run-in period (e.g. calculating surface area using length x width is acceptable).
The subject is excluded if the surface area measurement of the Target ulcer decreases by 20% or more during the 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1/randomization visit, during which time the subject received SOC.
A subject is excluded if they are malnourished: a score of less than 17 on the Mini Nutritional Assessment (MNA).
A Subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.
Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
A potential subject with end stage renal disease requiring dialysis is excluded.
A subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
A Subject treated with hyperbaric oxygen therapy or a Cellular Acellular, or Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit is excluded.

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 Thousand Oaks?

Yes, this clinical trial (NCT06550596) has an active research site in Thousand Oaks, 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.

Diabetic Foot Treatment Options in Thousand Oaks, CA

If you're searching for diabetic foot treatment options in Thousand Oaks, CA, this clinical trial (NCT06550596) 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 Thousand Oaks research site is actively enrolling participants for this clinical trial. You'll receive care from experienced diabetic foot 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 diabetic foot clinical trials near you to find additional studies recruiting in your area.

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