Notice Number: NOT-DK-18-017

Key Dates
Release Date: May 16, 2018

Issued by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

The purpose of this Notice is to inform the scientific community that on October 29, 2018, a workshop will be held in Bethesda, Maryland to permit investigators to present biomarker proposals for the Diabetic Foot Consortium (DFC).

Diabetic foot ulcers (DFU) are a common complication of diabetes and lead to about 100,000 lower extremity amputations per year in the United States. Treatment of 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 workshop is to solicit biomarker proposals that could be studied in the DFC.

Biomarkers The proposed biomarkers must increase our knowledge of diabetic foot ulcers and their healing. Examples of biomarker research topics are:

• Molecular or histologic detection of infection and biofilms in diabetic wounds.

• Surrogate end-points that when applied early in treatment can predict eventual healing.

• Assessment of the healed skin that can be used as an outcome measure and predictive biomarker for recurrence.

• Cellular and serum markers of inflammation and regeneration that predict healing or response to surgical and medical therapies.

• Risk factor models that combine wound and patient characteristics to predict healing or recurrence.

• Measures of tissue oxygenation and vascularization of the diabetic lower extremity that predict healing or response to therapy.

The biomarker does not need to translate into wide-spread clinical use, if it would fill an important need for clinical research. Biomarkers for the prediction of a primary diabetic foot ulcer are currently outside the scope of the DFC. The biomarker research must involve participants who either have a diabetic foot ulcer or a recent (<1 month) history of a diabetic foot ulcer. The proposed biomarker should have ample supportive data to justify a multi-site clinical study.

Diabetic Foot Consortium (DFC) The DFC consists of three components:

• Clinical sites for the DFC will be selected and funded through the Funding Opportunity Announcement, RFA-DK-17-014, which describes in detail the organization and activities of the DFC. Interactions with patients will only take place at the clinical sites.

• Biomarker measurement sites will receive biosamples and patient data from the clinical sites. They will then measure the biomarker in the biosample and analyze the results. For biomarkers that involve bedside measurements, such as imaging, the site will receive the data and analyze the results.

• A Data Coordinating Center will coordinate the data collection and statistical analysis. A Funding Opportunity Announcement for the DCC will be released.

Biomarker proposals The proposal for each biomarker or closely-related panel of biomarkers should include the following information:

• A description of the biomarker and its context of use.

• Published results and preliminary data on the biomarker.

• The method for measuring the biomarker that includes a clear description of the collection and transportation of biosamples and the reliability of the measurement.

• The clinical study design that includes the inclusion/exclusion criteria, timing of biomarker measurements, the collection of patient and DFU characteristics, and the measurement of clinical end-points. The study must focus exclusively on subjects with diabetes. The study may propose to study a subgroup of patients with DFUs, based on patient, ulcer or treatment parameters.

• A power analysis for the number of subjects needed for the study.

• An analysis plan for the results.

The proposed biomarker clinical study must involve recruitment of new subjects at multiple institutions. A collaborative group of investigators from multiple institutions and both domestic and foreign investigators may submit a proposal. Further information on the proposals can be found at the meeting website.

Presentations and meeting logistics Each biomarker proposal will have an oral presentation at the October 29, 2018 meeting. An agenda will be developed based on the number of proposals. In-person presentations are strongly encouraged to facilitate discussion. Each proposal should have a one-page synopsis that will be distributed at the meeting.

The meeting will be held at the Natcher Conference Center on the Bethesda campus of the National Institutes of Health. The campus is located a short distance from hotels in downtown Bethesda. The Medical Center stop on the Red Line of the Washington Metro subway system is on the NIH campus. A government-issued ID card is required to enter the NIH campus.

Further information A webinar will be held on June 29, 2018 to answer questions about the workshop. Contact Dr. Jones by email to request an invitation for the webinar?. More information on the workshop can be found at the meeting website. Investigators are encouraged to contact the DFC project scientist, Dr. Jones, before submitting a proposal.

Meeting website For registration and submission of a biomarker proposal.
https://www.niddk.nih.gov/news/meetings-workshops/2018/diabetic-foot-consortium-biomarkers

Important Dates

• June 29, 2018 Webinar for questions on the biomarker proposals and workshop.

• September 1, 2018 Letter of intent for submission of a biomarker proposal at the workshop. The letter of intent will be used for planning purposes. It should contain the title of the biomarker proposal and the names of the investigators and their institutions and be sent to Dr. Jones.

• October 8, 2018 Deadline for workshop registration and submission of the biomarker proposal.

• October 29, 2018 Workshop at the Natcher Conference Center on the NIH Campus, Bethesda, MD.

Inquiries

Please direct all inquiries to:

Teresa L. Z. Jones, MD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-435-2996
Email: teresa.jones@nih.gov