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Non-healing WoundEarly Phase 1NCT05921292

Omeza Combination Therapy for the Management and Treatment of Chronic Cutaneous Wounds/Ulcers of Multiple Etiologies

A Early Phase 1 study testing Omeza Products Used in Combination in people with Non-healing Wound and Non-Healing Ulcer of Skin, run by Omeza, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to evaluate the use of Omeza combination therapy with Standard of Care. The main question it aims to answer is: Can Omeza combination therapy with Standard of Care enable chronic wounds to begin a healing trajectory in a 4-week period? Patients will be treated with: OCM™ Wound Matrix… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-healing Wound, Non-Healing Ulcer of Skin
What is being tested?
Omeza Products Used in Combination
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
1 siteUnited States
Study dates
11 Jul 2022to 31 May 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is at least 18 years old and female subjects are not pregnant
  • Willing and able to comply with Trial procedures, including Trial visits and Trial dressing regimens
  • Targeted chronic wound/ulcer has been chronically present for at least two (2) months (8 weeks) as of the date the subject signs consent for study
  • Study target chronic wound/ulcer size is a minimum of 2.0 cm2 and a maximum of 100.0 cm2 without exposed tendon, muscle or bone
  • Willing and able to comply with study procedures, including study visits and study dressing regimens including ability of the subject to tolerate limb compression bandage, when applicable
  • Subject has read and signed the IRB-approved Informed Consent Form before screening procedures are undertaken.
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  • Additional Inclusion Criteria (for Subjects with Wounds/Ulcers in Lower Extremities):
  • The affected limb must have adequate perfusion confirmed by vascular assessment. Any one of the following methods performed within 1 or 2 months of the first screening visit are acceptable:
  • Ankle Brachial Index (ABI) between 0.8 and 1.3
  • Toe Brachial Index (TBI) > 0.6
  • Transcutaneous oximetry (TCOM) >40mmHg
  • Pulse volume recording (PVR): biphasic or triphasic waveforms
  • Confirmation of venous disease by non-invasive venous studies with either Doppler confirmed venous reflux or having ≥ 2 clinical characteristics of venous insufficiency (varicose veins, lipodermatosclerosis, venous dermatitis, atrophie blanche, edema). Biopsy done to exclude other skin conditions e.g., cancer on ulcers ≥ 6 months
  • Have a venous ulcer between the knee and ankle, at or above the malleolus
  • Subject understands and is willing to participate in the clinical study visits including compression if needed for minimum 14 days (compression dressing changed once weekly) prior to study start, participate in the informed consent process, and can comply with weekly visits and the follow-up regimen
  • If more than one chronic wound/ulcer is present on the same leg, they must be greater than 2 cm apart and only the larger chronic wound/ulcer will be included in the study (i.e., targeted lesion)
  • Additional Inclusion Criteria (for Subjects with Diabetic Foot Ulcer):
  • Diagnosed as having Type 1 or Type 2 diabetes
  • Any lower extremity wound should have at least one method of arterial testing (ABI, TBI, Arterial Doppler with Waveforms, Pulse Volume Recordings, Skin Perfusion Pressure, TcPO2) within 1 or 2 months of the first screening visit.
  • Presence of a DFU, Wagner 1 or 2 (see Appendix D for definitions), extending at least through the dermis provided it is below the level of the medial or lateral malleolus.
  • Known HbA1c of ≤12% within 6 months
  • The target wound will be located on the foot or ankle and will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 1 cm distant from the target wound

Who cannot join

  • Targeted chronic wounds/ulcers exhibit clinical signs and symptoms of infection, as evidenced by tissue necrosis, redness, pain, and/or purulent drainage and/or receiving systemic antibiotics for the treatment of such*
  • Targeted chronic wound/ulcer treated with a topical antibiotic within the last 7 days prior to first treatment with Omeza products.
  • NOTE: washout of topical antibiotics and antibacterial treatments (eg. Silver, manuka honey, iodine, etc) is at least 7 days before first treatment with Omeza products.
  • Targeted chronic wound/ulcer has been treated with any placental derived products, engineered material (e.g., Apligraf® or Dermagraft®) or other scaffold materials (e.g., Oasis, PuraPly AM or Matristem) within the last 30 days.
  • Targeted chronic wound/ulcer requires enzymatic debridement during the study
  • Targeted chronic wound/ulcer decreases in area by 30% or more during the 14 days screening/run-in period.
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  • Subjects who are unable to understand the aims and objectives of the trial or have a known history of poor adherence with medical treatment.
  • Subject is medically unable to consent (due to head trauma, coma, etc.) or cognitively impaired (due to being mentally challenged, having Alzheimer's, etc.)
  • Presence of any condition(s) that seriously compromises the subject's ability to complete this study.
  • Subjects with a BMI>65
  • Subject has any history of fish allergy or a known sensitivity to any of the SoC materials which contact the skin
  • Presence of any monophasic waveforms on segmental Arterial Doppler/Pulse Volume Recording
  • Subject is on dialysis
  • Any active cancer other than a nonmelanoma skin cancer; any previous cancer must be in remission for at least 1 year: bone cancer of metastatic disease of the affected limb, or has had chemotherapy within the last 12 months
  • Suspicion of malignancy within chronic wounds/ulcers: A biopsy must be performed for any wound that has been present for > 6 months and has not previously been biopsied. A biopsy should be performed regardless of duration of wound If a clinical suspicion of malignancy exists in the opinion of the Investigator.
  • Life expectancy < 6 months
  • Subject has received within 28 days of screening a treatment which is known to interfere with or affect the rate and quality of wound healing (e.g., thrombolysis, systemic steroids, immunosuppressive therapy, autoimmune disease therapy, dialysis, radiation therapy at wound site, chemotherapy) or who may receive such medications during the screening period or who has anticipated to require such medications during the course of the study at the discretion of the treatment PI.
  • Untreated osteomyelitis
  • Acute deep venous thrombosis
  • Allergy to lidocaine and/or epinephrine
  • Subject's inability to successfully tolerate compression therapy that is changed weekly
  • All females of childbearing potential who are not using a highly effective method of birth control (failure rate less than 1% per year), such as implants, injectables, combined oral contraceptives, some IUDs, practice sexual abstinence or have a vasectomized partner.
  • The use of the following treatments are prohibited within 30 days prior to randomized treatment and throughout the study:
  • Heat lamps
  • UV lights
  • Whirlpool baths
  • Hyperbaric oxygen
  • Topical or local insulin administration
  • Additional Exclusion Criteria (for Subjects with Wounds/Ulcers in Lower Extremities):
  • The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 1 or 2 months of the first screening visit are exclusionary:
  • Ankle Brachial Index (ABI) less than 0.7 or greater than 1.3
  • Toe Brachial Index (TBI) < 0.6
  • Transcutaneous oximetry (TCOM) <40mmHg
  • Suspicion of malignancy within VLU
  • Acute deep venous thrombosis
  • Study target chronic wound/ulcer extends more than 50% below the malleolus.
  • Additional Exclusion Criteria (for Subjects with Diabetic Foot Ulcer):
  • Target wound deemed by the investigator to be caused by a medical condition other than diabetes or subject has wounds secondary to a disease other than diabetes (e.g. vasculitis, neoplasms, or hematological disorders)
  • The affected limb of the diabetic subject must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 1 or 2 months of the first screening visit are exclusionary:
  • Ankle Brachial Index (ABI) between 0.8 and <1.3
  • Toe Brachial Index (TBI > 0.6
  • The subject is unable to safely ambulate with the use of a study required offloading method
  • Subject has unstable Charcot foot or Charcot with bone exposed that could inhibit wound healing
  • Osteomyelitis or bone infection of the affected foot as verified by x-ray within 30 days prior to randomization. (In the event of an ambiguous diagnosis, the subject will not be enrolled)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Christus St. Vincent

    Santa Fe, New Mexico, 87505

Other trials in United States

About this study

Official title: A Clinical Study to Evaluate the Omeza Combination Therapy for the Management and Treatment of Chronic Cutaneous Wounds/Ulcers of Multiple Etiologies

The goal of this clinical trial is to evaluate the use of Omeza combination therapy with Standard of Care. The main question it aims to answer is:

  • Can Omeza combination therapy with Standard of Care enable chronic wounds to begin a healing trajectory in a 4-week period?

Patients will be treated with:

  • OCM™ Wound Matrix
  • Omeza combination therapy
  • Standard of Care
Read the detailed description

The goal of this clinical trial is to demonstrate that the Omeza combination therapy with Standard of Care supports chronic wounds to move from chronicity to a healing trajectory. The trial is targeting those wounds that have failed therapy prior to trial enrollment and are chronic by definition of no change in area size after 2 weeks of standard of care treatment. The inclusion and exclusion criteria applied to this chronic wound clinical trial is broadened with the intention to include all patients and outliers that would not qualify for controlled trials.

Being tested
Omeza Products Used in Combination

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omeza Products Used in CombinationCombination product

    Also called Omeza® Lidocaine Lavage, Omeza® Complete Matrix (OCM™), and Omeza® Skin Protectant

    Subjects in this single-arm study will have the targeted wound/ulcer treated with Omeza® combination therapy which includes the use of the following products:

    • Omeza® Lidocaine Lavage
    • Omeza® Complete Matrix (OCM™)
    • Omeza® Skin Protectant At each treatment (on days 0, 7, 14, 21; +/- 3 days each), the patient's intact skin around the wound/ulcer will be prepped with Omeza® Lidocaine Lavage. OCM™ will be applied directly to the wound/ulcer and Omeza® Skin Protectant will be applied to the periwound and surrounding intact skin. Treatments may be repeated during an optional 7 additional weeks (on days 28, 35, 42, 49, 56, 63, and 70; +/- 3 days each). Final assessment will be made at week 12.
Study groups in NCT05921292
Study groupRoleWhat they receive
Omeza® Products Used in CombinationExperimentalSubjects in this single-arm study will have the targeted wound/ulcer treated with a combination therapy which includes the use of a wound preparation (2mL vial), a skin protectant (2mL vial), and a wound matrix (1.6g vial). Patients will be treated weekly for four weeks. Treatment may be continued weekly for an additional 8 weeks with participant and investigator agreement.
Receives: Combination Product: Omeza Products Used in Combination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Chronicity of Wound Healing

    The proportion of subjects with a clinically significant improvement in Study Ulcer Exudate Assessments at 4 weeks compared to baseline assessment.

    Measured: 4 weeks

  2. Change in Wound Area

    Percent change in wound area at 4 weeks as measured by wound imaging software. Sub-characterization will include wounds with baseline area of greater than or less than 100㎟.

    Measured: 4 weeks

  3. Wound Healing

    The objective response rate (ORR) will be used to define effectiveness at 4 weeks. The ORR is defined as the proportion of subjects at 4 weeks that have had at least a 40% reduction in the area of the wound volume from Day 0 measurements measured by wound imaging software.

    Measured: 4 weeks

  4. Wound Closure

    Proportion of subjects that have had complete closure at or prior to 12 weeks of treatment.

    Measured: 12 weeks

Secondary outcomes (6)

  1. Improvement in Quality of Life

    Change in the subject's Quality of Life (QoL). A numerical validated QoL scale (wound QoL Appendix F) specific for wound healing will be provided for participants to complete on a scheduled visit basis up to 12 weeks from Day 0.

    Measured: 12 weeks

  2. Reported Pain Perception

    Reported changes in pain perception will use a 10 cm Visual Analogue Scale and subjects will mark on the line from no pain to worst pain possible each scheduled visit.

    Measured: 12 weeks

  3. Drainage/Exudate and Infection

    Change in drainage/exudate and infection assessments. Drainage/exudate and infection assessment will be provided by the investigator in assessment of wounds at each week when changing dressings at each visit.

    Measured: 12 weeks

  4. Enhanced Activities in Daily Living

    Changes in the enhanced activities in daily living. Enhanced activities in daily living will be measured in an instrumental ADL scale at scheduled visits: the Barthel Index that measures the following criteria: chair/bed transfers, ambulation, ambulation/wheelchair, stair climbing, toilet transfers, bowel control, bladder control, bathing, dressing, personal hygiene, and feeding.

    Measured: 12 weeks

  5. Time to Closure

    This will be the time from Day 0 to the day that 100% or reepithelization without drainage or exudate has occurred. In addition, any wounds/ulcers that have not had complete closure by week 12 the maximum reported closure will be reported, and the data censored at 12 weeks.

    Measured: 12 weeks

  6. Incidence of Healing

    The proportion of subjects in which complete closure has occurred by Week 12.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2023
  2. Study start11 Jul 2022
  3. Primary completion22 Jan 2024
  4. Study completion31 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05921292
Sponsor's protocol ID
OM-CTP-002
Status last verified
Jun 2024
First submitted
19 Jun 2023
Last updated
21 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Omeza Products Used in Combination in people with Non-healing Wound and Non-Healing Ulcer of Skin, run by Omeza, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chronicity of Wound Healing (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05921292.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.

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