Diabetic Complications Consortium (DiaComp) Collaborative Funding Program: Diabetic Foot Ulcers - Planning Activities for Clinical Biomarker Studies

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. 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. Contact information: Richard McIndoe, PhD rmcindoe@augusta.edu