Ignite Creation Date:
2024-05-06 @ 5:45 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05417425
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2022-06-06
Brief Title:
Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers
Sponsor:
Omeza LLC
Organization:
Omeza LLC
Study Overview
Official Title:
A Clinical Study Using Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is to evaluate the efficacy of OCM used in combination with off-loading devices for the treatment of diabetic foot ulcers
Detailed Description:
The study will include three phases screening phase treatment phase and healing confirmation All measurements in the trial are captured by Tissue AnalyticsThe two week screening phase is to confirm the chronicity of the diabetic foot ulcer DFU and the eligibility of subjects Subjects will be treated with standard of care SOC which includes cleaning of the wound debridement when needed dressing and offloading If the ulcer decreases by 30 in area measurement after 2 weeks of SOC then the subject does not qualify for the treatment phase The treatment phase begins with assessment to confirm continued eligibility and if met subjects are treated weekly with the OCM therapy plus continued offloading At the conclusion of 4 weekly treatments the ulcer will be assessed by PI for response and evaluation of percent area reduction Continued therapy through treatment visit 12 is at the PIs discretion where percent area reduction is assessed and recorded
OCM results will be compared to a Control Group of subjects identified and matched retrospectively from the same site who received the same advanced treatments that the OCM treated cohort had received prior to the trial
OCM results will be compared to a Control Group of subjects identified and matched retrospectively from the same site who received the same advanced treatments that the OCM treated cohort had received prior to the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None