Diabetic Foot Consortium - Biomarker Meeting

Event Details

Background

Diabetic foot ulcers (DFUs) are a common complication of diabetes and lead to about 100,000 lower extremity amputations per year in America. Treatment for a DFU is costly, protracted, and, for many individuals, ineffective. The development of new therapies for diabetic wound healing is fraught with challenges, one of which is the lack of biomarkers to predict healing. The goal of the Diabetic Foot Consortium (DFC) is to validate biomarkers for DFUs through a network of clinical and biomarker measurement sites. The purpose of this meeting is to solicit biomarker proposals that could be studied by the DFC.

The DFC consists of three components:

• Clinical sites for the DFC will be selected and funded through the Funding Opportunity Announcement DK-17-014, which describes in detail the organization and activities of the DFC. Patient interactions will take place only at the clinical sites.
• Biomarker measurement sites will receive biosamples and patient data from the clinical sites and will measure the biomarker in the biosample and analyze the results. For biomarkers that involve bedside measurements, such as imaging, the sites will receive the data and analyze the results.
• A data coordinating center (DCC) will coordinate the data collection and statistical analysis. A Funding Opportunity Announcement for the DCC will be released in the future.

Registration Deadline

October 8, 2018

Agenda

October 29, 2018

8:30 a.m. – 8:40 a.m.

Welcoming Remarks

8:40 a.m. – 9:00 a.m.

Overview of the Diabetic Foot Consortium and Workshop Goals

9:00 a.m. – 10:30 a.m.

Presentations of Biomarker Proposals and Discussion

10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:15 p.m.

Presentations of Biomarker Proposals and Discussion

12:15 p.m. – 1:15 p.m.

Lunch

1:15 p.m. – 2:45 p.m.

Presentations of Biomarker Proposals and Discussion

2:45 p.m. – 3:00 p.m.

Break

3:00 p.m. – 4:30 p.m.

Presentations of Biomarker Proposals and Discussion

4:30 p.m. – 5:00 p.m.

General Discussion

Abstracts

Submission Deadline

October 8, 2018

Biomarker Proposals

The biomarker proposal should use the standard PHS 398 form, including face page, abstract/synopsis (one page), biosketches of key personnel, research plan, literature cited, and budget. Only one biomarker proposal is allowed for each principal investigator (PI). The proposal could include closely related biomarkers, and the PI can be a co-investigator on other proposals.

Synopsis (1 page)—a brief description of the rationale, methods, and clinical study design.

Biosketches—the National Institutes of Health biosketch format for all key personnel.

Research plan (8 pages)—should include the following sections:

• Description and context of use for the biomarker.
• Scientific rationale.
• Published results and preliminary data.
• Methods for measuring the biomarker
  • Description of the collection and transport of biosamples. Foreign sites should explain the procedure for receiving human samples from the United States.
  • Protocol for the biomarker measurement.
  • Data on the reliability of the measurement.
• Clinical study design that includes the inclusion/exclusion criteria, timing of biomarker measurements, the collection of patient and diabetic foot ulcer (DFU) characteristics, and the definition of clinical end-points.
• Power analysis for the number of subjects needed for the study.
• Analysis plan for the results.

Budget—The budget should include the costs at the biomarker assessment site and the additional costs of any specialized equipment that will be used at the clinical sites. The clinical sites will provide the personnel for collecting samples. The budget should include travel to Bethesda, Maryland, for biannual Diabetic Foot Consortium (DFC) meetings.

Proposal Selection

The DFC Steering Committee—consisting of the DFC chairperson, the PIs of the Clinical Research Units, and the National Institute of Diabetes and Digestive and Kidney Diseases project scientist—will meet on October 30, 2018, to select the biomarkers for further development for study by the DFC. The goal is to select as many high-quality biomarkers as the funding of the DFC allows. Development of the protocols will include harmonization of the testing so that multiple biomarkers could be assessed on the same participant.

The major criteria are—

1. The extent, quality, and relevance of the preliminary data. The biomarker should be at a stage in development for validation at multiple sites for the context of use stated in the proposal. Exploratory biomarker studies are not currently appropriate for the DFC, though the DFC plans to establish a data and sample repository.
2. The robustness of the method. What is the reliability of the measurement? For measurements that will be performed in the clinic, is the procedure amendable to training and performance by staff at multiple clinical sites? For biosamples that will be measured at the biomarker site, are the collection and shipping procedures practical for the clinic setting? For qualitative assays, what is the intra-rater and inter-rater reliability?
3. The experience of the PIs. Do they have the knowledge and experience with the proposed biomarker and the field of DFUs to provide scientific leadership at the biomarker site and on the DFC Steering Committee?

Submission Instructions

1. Register at www.scgcorp.com/DiabeticFoot2018/Registration.
2. Once completed, there will be a link on the registration confirmation page (and confirmation email) to submit your proposal.
3. Fill out your information and summary, and then upload your PDF proposal.