Satellite Site Information and Application Form

Thank you for your interest in the national network for the clinical study of diabetic foot ulcers (DFUs) – the Diabetic Foot Consortium (DFC).

Satellite Site General Information

As described in RFA-DK-22-509: Limited Competition for the Continuation of the NIDDK Diabetic Foot Consortium – Clinical Research Units (U01 Clinical Trial Optional)RFA-DK-22-509: Limited Competition for the Continuation of the NIDDK Diabetic Foot Consortium - Clinical Research Units (U01 Clinical Trial Optional) (nih.gov),we are seeking to build on the DFC infrastructure through ancillary studies and satellite sites.

The DFC currently has four Clinical Research Units (CRUs) and a Data Coordinating Center (DCC). In our second grant cycle (2023-2027), our Clinical Research Units will collaborate with satellite sites to accelerate the pace of the DFC studies.

The goals of the Satellite Pilot Program are:
  1. To establish effective collaborations between the CRU and new clinical sites that will involve shared values, cooperative problem-solving, high-level training, and synergies of resources
  2. To expand the number and diversity of DFU patients available for DFC studies and the types of DFUs and wound care settings.

The Satellite sites can be wound care practices, health care systems or academic institutions at any location in the United States and are not necessarily in the same geographic area as the CRU. The DFC is committed to reaching out and including understudied populations who have a greater risk for DFUs and poor outcomes. The Satellite sites should have a history of treating and studying these populations including racial and ethnic minorities and low-income groups; and to broaden the leadership base of the DFC through the addition of dedicated, knowledgeable investigators and training opportunities to junior investigators.

RFA-DK-22-509 describes the lists the responsibilities of the CRUs and the scientific goals for the DFC.

Each CRU is charged with partnering with at least two Satellite sites in the first four years of the grant. They will provide limited pilot-scale start-up costs at the Satellite site for training, management of regulatory approvals and protocol documents, and initial enrollment and follow-up of ~five participants in the DFC protocol for open DFUs. The costs associated with additional participants will be paid directly to the Satellite sites by the DCC. During this time, CRU involvement in supporting the Satellite sites with leadership advice and troubleshooting is expected to continue.

Satellite Site Documents

Satellite Site Requirements

  1. Submit an application to DFC-satellite@umich.edu. Applications will be reviewed on an ongoing basis.
  2. Review the active study protocols on the DFC website to determine if your site would be a good fit for the study goals and procedures.
  3. Have the facilities, equipment, and trained staff with the appropriate expertise, to follow all the study procedures, including the timeliness and quality of data and biosample submission.
  4. Agree to follow the DFC standard-of-care guidelines which are based on the published guidelines from professional societies ([1], [2], [3]) and closely cooperate with the sponsoring CRU.
  5. Have reliable internet capabilities at the wound care site.
  6. At the wound care site, have a centrifuge to separate blood components and same-day access to a -80° freezer or shipping on dry ice.
  7. Agree to the CRU Data Sharing Plan that follows to the NIH Data Sharing Policy and will be provided by the CRU PI upon request.
  8. Agree to use the central IRB selected by the DFC, currently WSG (formerly WIRB) IRB.
  9. Have interest in attending one in-person DFC Steering Committee meeting annually.
  10. Agree to complete a pre-screening log for one month of aggregate information on number of patients and their characteristics (does not include patient-level data) as part of the application process.

References

[1] American Diabetes Association Professional Practice Committee, and American Diabetes Association Professional Practice Committee:. "12. Retinopathy, Neuropathy, and Foot Care: Standards of Medical Care in Diabetes—2022." Diabetes Care 45.Supplement_1 (2022): S185-S194.

[2] Schaper, Nicolaas C., et al. "Practical guidelines on the prevention and management of diabetic foot disease (IWGDF 2019 update)." Diabetes/Metabolism Research and Reviews 36 (2020): e3266.

[3] Hingorani, Anil, et al. "The management of diabetic foot: a clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine." Journal of vascular surgery 63.2 (2016): 3S-21S.