Diabetic Foot Ulcer
Conditions
Keywords
Chronic Wounds, Wound Medicine
Brief summary
This study aims to compare two treatment approaches for diabetic foot ulcers (DFUs): the standard of care (SOC) alone versus SOC combined with OCM. Researchers will evaluate whether adding OCM increases the likelihood of ulcers healing completely by the end of the trial period.
Detailed description
This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet the study requirements during screening will be randomly assigned to one of two groups: either standard of care (SOC) alone, or SOC plus OCM. The study includes a crossover component for subjects in the SOC arm. At treatment visit 13 (approximately 84 days post-randomization), SOC arm subjects not having achieved complete wound closure, and still meeting the inclusion/exclusion criteria, are eligible to cross over to the IP arm (SOC plus OCM). Crossover subjects will begin IP arm treatment with weekly OCM applications for up to 12 treatment visits. The subject will continue follow-up per the original schedule. As this is a post-marketing study, it will gather information regarding the efficacy of treatment while also supporting insurance reimbursement decisions.
Interventions
DEVICEOmeza® Complete Matrix
OCM Application, Surgical sharp debridement, offloading (TCC gold standard, fixed ankle-walker alternative), and proper moisture balance
OTHERStandard of Care
Surgical sharp debridement, offloading (TCC gold standard, fixed ankle-walker alternative), and proper moisture balance
Sponsors
Omeza, LLC
SygNola, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The subject will be randomized to one of the following treatments: * Standard of care * OCM in addition to standard of care
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or Female, 18 years of age or older 2. Subject has a medical diagnosis of Type I or Type II Diabetes Mellitus requiring oral or glycemic control and/or insulin replacement therapy 3. Subject has a diabetic foot ulcer present for 4 weeks or greater (documented in medical record) and being treated with continuous SOC 4. Subject has a diabetic foot ulcer with a historical wound measurement showing less than 25% healing in 14 days prior to screening 5. Subject has a diabetic foot ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization 6. Subject has a diabetic foot ulcer of Wagner grade 1 or 2 7. Index ulcer is a minimum of 0.7cm2 and a maximum of 25cm2 at first treatment visit 8. Diabetic foot ulcer is being treated with offloading therapy for 14 days prior to randomization 9. Adequate circulation of ulcer demonstrated by an ABI of \>0.7 and \<1.3, or TBI of \>0.6 within 30 days prior to randomization OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to randomization. 10. Index ulcer is free of infection prior to randomization and during screening phase. Infection must be adequately treated and controlled as defined by Infectious Disease Society of America (IDSA) Guidelines PEDIS Grade 1. 11. Index ulcer is free of necrotic debris prior to OCMTM application 12. Female subjects of childbearing potential having a negative pregnancy test prior to randomization 13. Subject is able and willing to follow the protocol requirements 14. Subject had signed informed consent 15. If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm
Exclusion criteria
1. Subject has a known life expectance of \<1 year 2. Subject is unable to comply with protocol treatment 3. Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing 4. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound 5. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator 6. Known contraindications to fish products or cod liver oil. 7. Concurrent participation in alternative clinical trial that involves investigational drug or device interfering with wound treatment and/or healing 8. Subject is pregnant or breastfeeding 9. Subject with history of immunosuppressant treatment (systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for \>2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study 10. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 14 days prior to randomization 11. Wound depth with visible exposed bone 12. HBOT within 14 days prior to randomization 13. Revascularization surgery on the index ulcer leg within 30 days of screening phase 14. Index ulcer suspicious of neoplasm in the opinion of the principal investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Wound Closure | 1-12 weeks | The primary endpoint will be the percentage of target ulcers that achieve complete wound closure within 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Wound Area Change | 1-12 weeks | The percentage change in wound area from TV-1 to TV-13 will be measured weekly using digital photographic planimetry and physical examination. |
| Pain Assessment | 1-12 weeks | Change in pain associated with the target ulcer will be assessed using the Numeric Pain Rating Scale throughout the study. The Numeric Pain Rating Scale is measured between 0-10. 0 being no pain at all and 10 being the worst pain. |
Countries
United States
Contacts
CONTACTAngelina Ferguson, DNP
CONTACTSarah Moore, MBE
STUDY_DIRECTORAngelina Ferguson, DNP
SygNola, LLC
Outcome results
None listed