Chronic Diabetic Foot Ulcer Study

Enrolling now, participation for up to 14 weeks

Study Purpose

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.

Basic Details

CONDITION

Diabetic Foot Ulcer

ENROLLMENT PHASE

August 2019 through December 2019

REQUIRED PARTICIPANTS

100 people need to enroll in order to fulfill the trial’s purpose

RESEARCH GROUPS

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 STUDY

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.

ClinicalTrials.gov Identifier: NCT04133493

Who Qualifies

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

Have had the ulcer for 4 weeks prior to enrollment

Not received treatment with other Cell or Tissue Based product during the last 30 days

Research Study Schedule

Visit overview

12 weeks of treatment

15 appointments

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
Study schedule

Research Locations

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: legstudy@kerecis.com

Physician Contact & Location Information

1.Investigator: Dr. Eric J. Lullove

Office Number: (561) 989-9780

Office Address: 4855 W Hillsboro Blvd Suite B6 Coconut Creek FL 3307

2.Investigator: Dr. Christopher Winters

Office Number:317-745-5403

Office Address: American Health Network of IN, LLC Attn Research Department 8607 E US 36 Avon, IN 46123

3.Investigator: Dr. Brock Liden

Office Number:(740) 474.3850

Office Address: Brock A Liden DPM 8090 Garden Drive Pickerington, Ohio 43147

4.Investigator: Dr. Allen Raphael

Office Number: (770) 319-5502

Office Address: Village Podiatry Centers – Smyrna 3200 Highland Pkwy Suite 100 Smyrna, Ga 30082

5.Investigator: Dr. Bert Altmanshofer

Office Number: (814) 696-3397

Office Address: Dr. Bert Altmanshofer 1798 Plank Road Suite 201 Duncansville, PA 16635

6.Investigator: Dr. Patrick McEneaney

Phone:(847) 639-5800

Office Address: Northern Illinois Foot & Ankle Specialists / Patrick McEneaney DPM 750 E. Terra Cotta Avenue, Unit C Crystal Lake, IL 60014

Office Address: Northern Illinois Foot & Ankle Specialists 113 West Main Street Cary, IL 60013

Office Address: Northern Illinois Foot & Ankle Specialists 165 N. Lakewood, Suite A Lake In The Hills, IL 60156

Office Address: Northern Illinois Foot & Ankle Specialists 1288 S. US HWY 12 Fox Lake, IL 60020

9.Investigator: Dr. Jonathan Hook

Office Number: (312) 842-4600

Office Address: 1435 S. Prairie Unit L Chicago, IL 60605

10.Investigator: Dr. Belinda Marcus

Office Number: (770) 538.1772

Office Address: Midland Orthopedic Associates 2850 S. Wabash Sutie 100 Chicago IL 60616

11. Investigator: Dr. Igor Zilberman

Office Number: (954) 278-3890

Shipping Address: 5505 Peachtree-Dunwoody Rd Suite 370 Atlanta, GA 30342

12. Investigator: Dr. Adam Bressler

Office Number: (404)297-9755

Office Address: 2665 N. Decatur Rd. Suite 330 Decatur, GA 30033

Next Steps

1 | Connect with Research Site

Find Study Site

2 | Visit Research Site

3 | Participate in Research Study

Frequently asked questions

Will I receive a placebo?

A placebo is not the study drug, but looks exactly like the study drug being investigated.

This research study is not using a placebo.

Everyone in this study will receive an active treatment for their ulcer.

At the beginning of the study, you will be randomly assigned (randomized) into one of two study treatment groups:

  • One group will receive the treatment device, Kerecis 0mega3 Wound
    • You have a 50% chance of receiving the study device.
  • One of the study treatment groups will receive current standard of care treatment.
    • You have a 50% chance of receiving the Standard Active Treatment.

Later in the study, if you do not respond to the treatment you receive in 6 weeks, you will exit your study arm and offered to switch to get the study device or standard of care. This step of the treatment is not formally part of the study.

What are my rights as a research study participant?

  • You have the right to drop out at any time.
    • You don’t have to give a reason.
  • You have the right to not participate in the research study.
    • Even if you’ve made it through screening and are “approved” to participate in the research study, you do not have to participate. If you decide to participate, you can change your mind at any time. You don’t have to give a reason for leaving.
  • You have the right to be given new information about the study.
    • Informed consent is an ongoing process. You will be informed of any changes throughout the course of the study.
  • You have the right to ask questions at any time.
    • You can ask questions about anything you don’t understand, or just want to know, at any time.

Is there a cost to participate in the research study and will I be paid?

All cost of the treatment device and standard of care treatment will be provided by the study sponsor. Some treatments that you receive in this study may be part of routine treatment for your chronic wound. The cost of these routine treatments will be billed to your insurance company.

You will not be paid to participate in this study.

What are some of the risks and benefits of participating in this research study?

All devices and treatments in this study are FDA approved and are being tested under accepted indications. You will have the opportunity to discuss risks and benefits in detail with the research site before agreeing to participate.

Possible Benefits

  • You may have access to a new treatment for diabetic foot ulcers.
  • You will receive close monitoring, care, and support from a research team of doctors and other healthcare professionals who understand atopic dermatitis.
  • You will play an active role in your healthcare.
  • You could be part of the development of a new treatment for diabetic foot ulcers, helping many others like yourself.

Possible Risks

  • You may not see results from the treatment.
  • You may receive the standard of care instead of the treatment device being studied.
  • You may experience side effects.
  • You may face substantial time commitments during the research study.

Will my personal information be kept confidential?

If you meet the high-level eligibility requirements and would like a nearby research site to contact you, we will share your contact information and survey responses so research site staff can discuss study participation with you in greater detail.

If you decide to participate, your privacy will be carefully protected. All of the data collected from study participants will be kept confidential. Only de-identified data will be used to analyze study results. The results of the study, including your de-identified data, may also be presented at meetings or articles written about the study. When the results of the study are published, your identity will remain confidential.