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The goal of the NIDDK-sponsored Diabetic Complications Consortium (DiaComp) is to advance the study of diabetic complications and promote communication and collaboration between investigators involved in complications research by supporting scientific meetings and funding new research activities.

adipose Diabetic Foot Ulcers – Planning Activities for Clinical Biomarker Studies
Applications requesting up to $100,000 in total costs for one year are due March 10, 2017.

Diabetic foot ulcers are the most common cause of non-traumatic lower leg amputation in the United States. Despite efforts to prevent and treat foot ulcers, each year about 70,000 Americans with diabetes will lose part of their lower extremity because a foot ulcer becomes infected or does not heal. An obstacle to the development of therapies is the paucity of validated biomarkers that assess healing, infection, and recurrence risk, and validated outcomes that measure patient satisfaction and quality of life. In addition, systematic reviews of clinical studies on the prevention and management of diabetic foot ulcers consistently point to the urgent need for clinical trials with standardized definitions, outcomes, biomarkers, and protocols that will enable a thorough evaluation of treatments and comparison of results across trials.

The purpose of this program is to support planning activities for the development of a multi-center study for clinical biomarkers and outcome measures for diabetic foot ulcers. It is also part of an effort by the NIDDK to support clinical studies that involve two or more institutions to build a collaborative framework for ongoing research on diabetic wound healing.

Applications should propose a future clinical study based on the criteria listed below. The application should include a rationale for the future clinical study, documenting significance and need, and describe the potential impact of the clinical study on biomarkers and research infrastructure. Preliminary results and background to support the study and an overview of the study design should be provided. The latter should include an estimate of the number of subjects, entry criteria, and outcome measures. In addition, the application should describe the planning activities proposed to be conducted during the single year of this program. These may include meetings to develop the protocol, focus groups for the patient-centered outcomes, clinical studies to obtain preliminary data, quality control testing of patient sample analysis, biostatistical analysis to develop sample size calculations, or analysis of databases to inform recruitment strategies. The goal of the planning activities is to develop a complete study protocol for the validation of a biomarker or outcome measure for diabetic foot ulcers.

The future, proposed clinical study should meet the following criteria:

  • The proposed study should address a significant gap in ulcer and patient assessment that obstructs progress in clinical research or patient care in this area. A biomarker that would fill a critical need for clinical research, but due to its complexity or expense, may not be practical for widespread adoption, would still be responsive to this program.
  • The future clinical study should be supported by preliminary data or published results that justify a multi-site clinical study. Discovery research, such as an “-omics” approach to wound samples, is not appropriate for this program. Obtaining additional preliminary data that would support the clinical study, can be proposed as a planning activity.
  • The scope of the project can range from a biomarker of a specific process of wound healing or infection to a broad model with a multi-factorial prediction of healing.
  • The proposed clinical study must involve recruitment of new subjects at multiple institutions. The use of stored samples or databases could be used to augment findings in the main study. A goal of this program is to foster collaboration in the standardization of protocols. The application for planning activities can come from a single institution, but should discuss the organization of multi-site clinical study and plans to recruit additional sites.
  • The research needs to focus exclusively on subjects with diabetes. The biomarker may be applicable to wound healing in non-diabetic subjects, but the proposed clinical study should only include subjects with diabetes. The study may propose to exam a subgroup of patients with diabetes, such as patients with end-stage renal disease, if it is justified scientifically.

It is anticipated that the NIDDK will publish a future FOA for a Cooperative Agreement for a Data Coordinating Center (DCC) to coordinate multi-site, clinical studies on diabetic foot ulcers. In conjunction with the NIDDK, the DCC will request the completed study proposals in Spring, 2018 and convene an External Evaluation Committee to make recommendations on the priority of the studies for implementation by the investigators and the DCC. Study proposals will not be limited to awardees from this DiaComp program. 

Topics for a clinical study include, but are not limited to:

  • 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 markers of inflammation and regeneration that assess the effect of surgical and medical therapies.
  • Risk factor models that combine wound and patient characteristics to predict healing or recurrence.
  • Patient questionnaires and clinical scales to assess patient satisfaction, quality of life, and function with treatment and outcomes.

Applications for the Collaborative Funding Program are only accepted from 10/28/2016 12:00:00 AM to 3/10/2017 11:59:59 PM.

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The application budget needs to reflect the actual needs of the proposed project and cannot exceed $100,000 in total costs (direct + F&A costs). The project period is one year. The program anticipates funding up to five awards, which is dependent upon the number, quality, and cost of the applications received. Awards will be made as subcontracts from the DiaComp Coordinating and Bioinformatics Unit (CBU) at the Augusta University and not directly by the NIH.

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For instructions on how to submit a Collaborative Funding Program Application to the DiaComp web portal please click the following link: Funding Program Application Submission Basic Training (PDF) All applications must be submitted via the DiaComp website (PDF format only please). 

The application is the standard PHS 398 form including face page, abstract, detailed budget, Biosketch, and research plan. The research plan (Sections A-D are limited to 6 pages) should include the following sections: 

  1. Specific Aims for the one year planning activities (one page),
  2. Significance of the proposed biomarker or outcome measure for patient care or therapy development;
  3. Preliminary or Published Studies to support further validation of the proposed biomarker or outcome measure,
  4. A Summary of the Proposed Clinical Study that includes a description of:
    1. The study population,
    2. The methods for obtaining and measuring the biomarker,
    3. The biostatistical justification of the study size and plan for analysis of the results,
    4. The organization of the study leadership, personnel and sites including plans for developing a standardized protocol across institutions.
  5. Literature Cited,

Eligible Project Directors/Principal Investigators: Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Eligible Organizations: Public/State Controlled Institution of Higher Education; Private Institution of Higher Education; Hispanic-serving Institution; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Alaska Native and Native Hawaiian Serving Institutions; Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education); Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education); Non-domestic (non-U.S.) Entity; Small Business; For-Profit Organization (Other than Small Business); State Government; Regional Organization; U.S. Territory or Possession; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); Indian/Native American Tribally Designated Organization; Eligible agencies of the Federal government; Faith-based or community based organizations; Foreign institutions.

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Each application will receive a primary review by multiple external referees and be given scores for Significance, Investigator, Innovation, Approach, Environment and an Overall Score based on the NIH Scoring System for Research Applications. Scores will range from 1 to 9, where a score of 1-3 indicates an application addressing a problem of high importance/interest and may have some or no weaknesses. A score of 4-6 may be addressing a problem of high importance, but weaknesses in the criteria bring down the overall impact to medium. A score of 7-9 may be addressing a problem of moderate/high importance, but weaknesses in the criteria bring down the overall impact to low. Reviewers will strongly consider the goal of the program to support the development of clinical studies of biomarkers and patient-centered outcomes for diabetic foot ulcers. A funding program specific External Evaluation Committee (EEC) will provide a secondary review of all applications. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed. No additional materials may be submitted after the receipt date. Written comments will be provided for all reviewed applications. Final funding decisions will be made by the NIH. All decisions are final and appeals will not be accepted for applications submitted in response to this solicitation. Funded awards are not allowed to submit a competitive renewal application and unfunded applications are not allowed to revise and resubmit an amended application.

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November 3, 2016 Announcement of DiaComp Biomarker Project is posted on DiaComp website, and other related websites
December 16, 2016 Q&A Webinar on this announcement. Contact Teresa Jones for an invitation.
March 10, 2017 Receipt date for applications that are submitted to CBU (Dr. Richard McIndoe, CA 4127, Augusta University, Augusta, Georgia, 30912)
May 31, 2017 Projected start date for Planning Activities funding
Spring, 2018 Full clinical study proposals are submitted to the Data Coordinating Center for evaluation.

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Research involving human subjects is limited to observational studies with non-invasive or minimally invasive testing and must have IRB approval that includes the collection and use of human samples for research purposes. Interventional clinical trials are beyond the scope of this program. The use of tissue from debridement or surgical procedures that are part of routine clinical care is acceptable.

Foreign institutions and organizations are eligible for support

A summary of progress of funded projects is due two months following the completion of the funding period.

DiaComp awardees must follow NIH and HHS policies regarding the sharing of data and resources with the scientific community (http://grants.nih.gov/grants/sharing.htm) and agree to submit to the DiaComp web portal all data and resources resulting from the execution of the awarded application.

Proprietary data and resources will be excluded from sharing consistent with NIH and HHS policies (http://grants.nih.gov/grants/sharing.htm).

Financial acknowledgment of award: Please acknowledge all posters, manuscripts or scientific materials that were generated in part or whole using funds from the Diabetic Complications Consortium (DiaComp) using the following text: 'Financial support for this work provided by the NIDDK Diabetic Complications Consortium (DiaComp, www.diacomp.org), grant DK076169'.

For presentations and slides, please use the PowerPoint slide with the funding source logo found in the zip file here - http://diacomp.org/images/diacomp-logos.zip - to indicate that DiaComp is a funding source for your presentation.

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Richard McIndoe, Ph.D. (Coordinator)
Coordinating and Bioinformatics Unit
Augusta University
Center for Biotechnology and Genomic Medicine
1120 15th Street, CA4124
Augusta, GA 30912-4810
Phone: 706-721-3542
Fax: 706-721-3688

Teresa L. Z. Jones, M.D. (NIDDK Program Director)

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