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

NCT05921292 | Completed Early Phase 1 FDA Drug FDA Device

• 1 other identifier: OM-CTP-002
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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
• Omeza combination therapy
• Standard of Care

Conditions

Non-healing Wound; Non-Healing Ulcer of Skin

Outcome Measures

Primary Outcomes (4)

• 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.

  4 weeks

• 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㎟.

  4 weeks

• 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.

  4 weeks

• Wound Closure

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

  12 weeks

Secondary Outcomes (6)

• Improvement in Quality of Life

  12 weeks

• Reported Pain Perception

  12 weeks

• Drainage/Exudate and Infection

  12 weeks

• Enhanced Activities in Daily Living

  12 weeks

• Time to Closure

  12 weeks

Study Arms (1)

Omeza® Products Used in Combination

EXPERIMENTAL

Subjects 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.

Combination Product: Omeza Products Used in Combination

Interventions

Omeza Products Used in Combination COMBINATION_PRODUCT

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.

Also known as: Omeza® Lidocaine Lavage, Omeza® Complete Matrix (OCM™), and Omeza® Skin Protectant

Omeza® Products Used in Combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)

You may not qualify if:

• 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.
• a. 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.
• 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.

Sponsors & Collaborators

• Omeza, LLC: lead

Study Sites (1)

Christus St. Vincent

Santa Fe, New Mexico, 87505, United States

Location

MeSH Terms

Interventions

oncomodulin

Study Officials

• Desmond Bell, DPM

  Omeza Holdings, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 27, 2023
• Study Start: July 11, 2022
• Primary Completion: January 22, 2024
• Study Completion: May 31, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)