Chronic Diabetic Foot Ulcer Study
Enrolling now, participation for up to 14 weeks
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA-cleared product that is from minimally processed Atlantic cod fish skin: Kerecis Omega3 Wound. The aim is to compare the effectiveness of the treatment device to standard of care.
Diabetic Foot Ulcer
Through December 2020
100 people need to enroll in order to fulfill the trial’s purpose
Initially, 50% of study participants will receive the treatment device, and 50% will receive standard of care treatment; including wound cleaning, dressing changes and offloading. Later in the study, what a participant receives may change depending on how their ulcer is doing.
Post-Market clinical trials are conducted to identify and evaluate the long-term effects of new drugs and treatments over a lengthy period for a greater number of patients. Phase IV research takes place after the FDA approves the marketing of a new device.
You may qualify for this research study if you meet the criteria listed below. You can learn if you qualify after you indicate your interest in the research study.
Have received a diagnosis indicating you have Diabetic Foot Ulcer
Not received treatment with other Cell or Tissue Based product during the last 30 days
Research Study Schedule
12 weeks of treatment
30 minutes on average
The study will go on until your wound heals or a maximum of 12 weeks of active treatment.
Each appointment is a little different. For example, you may engage in any of these activities at a visit:
- Laboratory tests (clinical chemistry, hematology, pregnancy, etc.)
- Vital statistics taken (weight, height, blood pressure, etc.]
- Underqo physical exams , Cleaning and preparation of wound
- Application of study device
- Complete questionnaires
The map below shows locations that are currently open for enrollment. Connect to the site of your choice. None of the sites fits your needs? Please contact us for more information. More sites will be added soon: email@example.com