Diabetic Complications Consortium (DiaComp) Announces New Collaborative Funding Program

Here is the announcements from Diabetic Complications Consortium (DiaComp):

"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."

For more information: https://www.diacomp.org/shared/collaborative.aspx