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 "Exploration of the Diabetic Foot Ulcer Niche" - Collaborative Pilot Program
Applications requesting up to $750,000 in total costs are due January 25th, 2018. Background: 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 a lower extremity because a foot ulcer becomes infected or does not heal. An obstacle to the development of therapeutics and biomarkers in this area is the paucity of basic fp-information describing the molecular processes and cellular changes underlying diabetic skin and its wound pathobiology. Significant untapped potential for novel wound therapy treatments may lie within the numerous molecular, cellular, and structural aspects of the skin that have been implicated in impaired diabetic wound healing. However, to-date, most research studies have tended to focus on a limited number of proteins or pathways that are altered within specific cell types in diabetic wounds. Thus, developing a detailed, comprehensive knowledge base of the molecular features associated with foot ulcer development in diabetes patients will address a significant gap in our understanding of how and why diabetic foot ulcers fail to heal. Purpose:The purpose of this Pilot Program is to adapt and evaluate emerging techniques focused on defining cell types and subtypes and their three-dimensional context to the study of diabetic foot ulcers. This will be accomplished by funding pilot studies to conduct key establishing experiments that will be necessary to fp-inform any future construction of an unbiased atlas of diabetic skin and foot ulcers. Pilot projects will be composed of multidisciplinary teams that consist of partnerships between: 1) clinical scientists with experience in diabetic foot ulcer biology and access to fresh human biopsies/surgical material for analysis, and 2) investigators with expertise in applying a diverse set of agnostic, medium- to high-throughput technologies with single cell-resolution to the systematic exploration of the cellular diversity of human tissues (e.g., CLARITY combined with highly multiplexed profiling of proteins and/or RNAs, imaging mass cytometry, etc.) or human tissue-derived cells (e.g., RNAseq, Dropseq, ATACseq, etc.). Objectives: The objectives of the Pilot Program are to 1) establish protocols for the collection, preservation, storage, and processing of diabetic skin and foot ulcer tissue, 2) adapt and utilize agnostic, single cell-resolution technologies of tissues and tissue-derived cells to assess the cellular complexity of intact and wounded tissues in diabetic patients, and 3) critically evaluate limitations of current methodologies for their application to the context of diabetic foot ulcers and explore potential solutions to begin to bridge these gaps. Clinical Sample Collection: Pilot projects should collect samples from routine clinical debridement that includes tissue at various locations in the wound and adjacent tissue. Samples for future analysis such as blood and microbiome/biofilms should also be collected and stored. It is expected that applicants will obtain appropriate consent to broadly share samples, de-identified patient fp-information, and experimental data. Consent should also permit following the course of wound healing after sample collection in order to include that fp-information in metadata associated with samples and their analysis. Essential Elements of Proposals Applications should include the following elements as subsections of the Research Plan (see below in Application & Eligibility for overall application instructions):
  • Clinical Sample Rationale: A detailed rationale for and description of clinical samples to be collected (e.g., total number of samples, number of samples per patient, location in/around wound bed, cross-sectional versus longitudinal design, etc.) and their overall importance to the goal of exploring the diabetic foot ulcer niche must be presented. This should include estimates of the amount of tissues to be collected and the needed quantities in experiments. Key phenotypic characteristics of the patients and what patient fp-information will be associated with samples should be described. Only samples from people with diabetes (type 1 or type 2) are allowed for this program.
  • Overall Research Design: A description of the overall research design and technologies that will be undertaken to adapt and evaluate emerging techniques focused on defining cell types and subtypes and their three-dimensional context to the study of diabetic foot ulcers. It expected that applications will utilize skin and wound samples that include both the epidermis and dermis and will discuss how cells from various relevant sub-tissue types (e.g., fibroblasts, nervous tissue, vasculature, keratinocytes, eccrine glands, macrophages, etc.) will be sub-classified.
  • Technology Development and Validation: A detailed plan to evaluate how collection, preservation, storage, and processing of cells and tissues affects the down-stream readouts of the proposed technologies. This plan should address how relevant metadata (e.g., patient phenotype, location, and orientation on the body of collected tissues, handling steps, high-resolution images of the wound at the time of collections and during the healing phase that follows, etc.) will be associated with samples and resulting data.
  • Analysis and Statistical Approaches: A description of the analytical and statistical approaches that will be used to compare cell/tissue composition at the different sample sites within individuals (e.g., unhealing tissue, leading edge, distal tissue, etc.) and how these approaches could be used to frame questions and generate hypotheses about the differences between healing versus non-healing wounds. Applicants should indicate how data will be stored, shared, and visualized between sites and with NIDDK staff.
  • Prior Experience of the Multidisciplinary Team: The clinical component of the team should demonstrate its ability to collect samples from clinically well-phenotyped individuals with diabetic foot ulcers and to rapidly transport fresh biopsy/surgical samples to the experimental laboratory. The technology-driven component should demonstrate its ability to apply state-of-the-art single cell-resolution approaches to explore the cellular diversity of complex tissues as well as the needed expertise to analyze, define cells by subtypes, and visualize the resulting data.
  • Commitment to Work as a Consortium: The team should indicate its commitment to work with other awardees in the Pilot Program, DiaComp, and other related NIDDK research efforts to communicate regularly to discuss common concerns, develop standards and quality control metrics, and share pre-publication data to assure the inter-operability of approaches. An in person kick off meeting will be held at the start of awards to harmonize tissue collection protocols to the maximum extent possible and develop a set of common analysis techniques across pilot projects. Applicants should indicate their willingness to share clinical samples with other Pilot awardees and to deposit excess samples in the NIDDK Central Repository (https://www.niddkrepository.org/home/) at the end of the Pilot award.
  • Protection of Human Subjects: When applicable, proposals must include a protection of human subjects section that addresses 1) risks to human subjects, 2) human subjects involvement and characteristics, 3) recruitment and fp-informed consent, 4) inclusion of woman and minorities, and 5) inclusion of children. Additional sub-items that should be included in this section can be found under "Application & Eligibility". If the investigative team does not obtain private identifiable fp-information, the proposed research may not be considered human subjects research. An example would be the use of discarded tissue from a wound debridement in which the individuals involved in the research do not have private identifiable fp-information on the patient. Please see https://humansubjects.nih.gov/human-specimens-cell-lines-data for more fp-information. If applicants determine proposed studies are not considered human subjects research, they should provide a rationale for this. For questions, please contact Dr. Pawlyk.
Proposals that are NOT RESPONSIVE to this Solicitation:
  • Applications that focus on studying only certain subtypes of cells or that utilize a small number of markers that do not constitute an agnostic and comprehensive approach to exploring the molecular, cellular and biological diversity of diabetic wounds and surrounding skin;
  • Applications that do not focus on the study of diabetic foot ulcers from diabetic (type 1 or type 2) patients;
  • Applications that do not contain a multi-disciplinary team that covers all expertise needed to conduct tissue collection and their consequent analysis;
  • Applications that do not include a plan to assess how sample collection, processing, and storage influences the results of experiments;
  • Applications that propose any form of non-human animal studies.
Applications that are deemed not responsive will be returned to the applicant and will not be reviewed. Receipt and Due Dates Proposals are due January 25th, 2018 for an April 30th, 2018 start date. Only domestic (U.S.) institutions and organizations are eligible for support. Budget Applicants may request up to $750,000 Total Costs (direct + indirect costs) to support a project period of up to 2 years. Budget requests should be commensurate with project needs during this period. A narrative justification should be provided for any major equipment (cost greater than $5,000) deemed to be necessary for the proposed project. It is expected that any application requesting any single piece of equipment in excess of $25,000 will provide evidence of a cost-sharing commitment from the applicant institution. The number of awards will depend upon the number, quality, duration, and cost of the applications received as well as programmatic priorities to assure that a variety of approaches are represented to describe the unique architecture and composition of diabetic wounds, and that an appropriate technological breadth is incorporated across the Pilot Program. Applicants should budget for travel to face-to-face meetings with other awardees and NIH staff during the 1st and 2nd years of the awards. Awards will be made as subcontracts from the DiaComp Coordinating and Biofp-informatics Unit (CBU) at Augusta University and not directly by the NIH. Peer Review Each submitted proposal will be assigned to multiple reviewers who are external scientists with expertise in the areas of the proposal. Reviewers will strongly consider the goal of the program to support the future development of an "atlas" of diabetic skin and diabetic foot ulcers. An ad hoc solicitation-specific External Evaluation Committee (EEC) will provide a secondary review of all applications. Applications that are incomplete, non-compliant and/or not responsive will not be reviewed. No additional materials may be submitted after the receipt date. Final funding decisions will be made by the NIDDK. All decisions are final and appeals will not be accepted for applications submitted in response to this solicitation. Timetable for "Exploration of the Diabetic Foot Ulcer Niche" Collaborative Pilot Project September 1st, 2017: Announcement posted on the DiaComp website and other related websites, and notification of the postings is sent to US academic and research institutions.
October 30, 2017: WebEx meeting - DFU Pilot Webinar
Join WebEx meeting (Click here)
Meeting number (access code): 620 903 410
Meeting password: gxA8mxRh

Join by phone
1-650-479-3208 Call-in toll number (US/Canada) - Access code: 620 903 410

Monday, October 30, 2017 | 1:00 pm Eastern Daylight Time (GMT-04:00) | 1 hour 30 minutes
Host: Aaron Pawlyk

January 25th, 2018: Grants Submitted to CBU
April 30th, 2018: Projected start date for Collaborative Pilot Project Funding
Application & Eligibility The application is the standard PHS 398 form including face page, abstract, detailed budget, biosketches (up to 5 pages each), and research plan. The research plan (Sections A-C are limited to 7 pages) should include the following sections:
  • Specific Aims,
  • Research Design and Methods,
    1. Clinical Sample Rationale,
    2. Overall Research Design,
    3. Technology Development and Validation,
    4. Analysis and Statistical Approaches,
  • Prior Experience of the Multidisciplinary Team,
  • Protection of Human Subjects (If applicable - For studies that are not considered human subjects research, applicants should instead provide a rationale for this.)
    1. Risks to Subjects
    2. Human Subjects Involvement and Characteristics
      1. Sources of materials
      2. Potential risks
      3. Adequacy of Protection against Risks
    3. Recruitment and fp-informed consent
      1. Protections against Risks
      2. Potential benefits of the proposed research to the subjects and others
      3. Importance of the knowledge to be gained
    4. Inclusion of Women and Minorities (including PHS Inclusion Enrollment Report)
    5. Inclusion of Children
  • Commitment to Work as a Consortium,
  • Literature Cited,
  • Sharing Plan
Terms and Conditions of the Award: Applicants must state their willingness to participate in a face-to-face kick-off meeting in May or June, 2018, 3-4 videoconferences (every 4-6 months) to present and discuss scientific progress and challenges as well as a face-to-face meeting in early summer, 2019. 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. New investigators are encouraged to apply, but they must have a full-time faculty position or an equivalent position at non-academic institutions. Given the difficulty and complexity of the task at-hand, the team must have a track record in 1) the collection of human skin and/or wound samples, 2) the application of a diverse set of agnostic, cell-resolution technologies to tissues, and 3) the ability to rapidly transport biopsy/surgical materials to the experimental laboratory. 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);; 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. Non-domestic (non-U.S.) Entities and components are not eligible to apply. Policies A summary of progress of funded projects is due two months prior to the completion of the first year of the funding period. The continuation of projects into their second year of funding will be dependent on progress and the awardees demonstrated willingness to work with other Pilot Program awardees. Research involving human subjects must have IRB approval that includes the collection and use of human samples for research purposes. Documentation of IRB approval can be provided as JIT (Just-In-Time) fp-information should an award be selected for funding. Interventional clinical trials are beyond the scope of this program. The fp-informed Consent form must allow submission of the biologic samples and data to the NIDDK Repository. 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. Data and resources may include, but are not limited to: histology images, protocols, experimental data, RNAseq, and progress report(s). All data and resources generated with DiaComp support will be made immediately available to "active" DiaComp awardees (see below) and publicly available on the DiaComp website: (1) at the time of first publication, or (2) one year after the award ends. Under certain circumstances, investigators may request an exception to the DiaComp public release policy by contacting NIH Program staff and requesting a waiver. Such requests will be reviewed on a case-by-case basis and waivers will be granted only with sufficient and compelling prior justification. DiaComp awardees are considered "active" and granted full access to the DiaComp website as members of the DiaComp "Steering Committee" for the duration of their funding period plus 4 years. Outgoing awardees may request an extension from NIH Program staff beyond this "active" period. 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) Proprietary data and resources will be excluded from sharing only when 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 (RRID:SCR_001415, www.diacomp.org), grants DK076169 and DK115255'. For presentations and slides, please use the PowerPoint slide with the funding source logo found in the zip file here - http://www.diacomp.org/images/diacomp-logos.zip - to indicate that DiaComp is a funding sources for your presentation. Submission of Pilot Program applications: 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)
Contact fp-information Richard McIndoe, Ph.D. (Coordinator)
Coordinating and Biofp-informatics 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
Aaron C. Pawlyk, Ph.D. (NIDDK Scientific Contact)
Senior Advisor for Pharmacogenomics and Drug Discovery
National Institute of Diabetes and Digestive and Kidney Diseases
Tel: 301-451-7299
Email: pawlykac@mail.nih.gov

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