Diabetic Wound Healing-Translation and Clinical Opportunities

Event Details

Meeting Objectives

The goal of this workshop, sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and held in conjunction with the Diabetes Limb Salvage Conference sponsored by MedStar Georgetown University Hospital, is to explore scientific opportunities and challenges in translating and testing new therapeutic interventions for diabetic wound healing.

Agenda

October 9, 2013

8:00 a.m.

Welcoming Remarks From the NIDDK Director
Griffin Rodgers, M.D., MACP

Pre-clinical Research

Moderator: Marjana Tomic-Canic, Ph.D.

8:10 a.m.

What is the current state of progenitor cell research for wound healing? What are the barriers for moving this research to clinical testing?
Geoffrey G. Gurtner, M.D.

8:25 a.m.

Of the many molecular and cellular changes from diabetes that impact the many steps in wound healing, which ones play a central role in the pathology of diabetic foot ulcers? What are the most promising drug targets and biomarkers?
Marjana Tomic-Canic, Ph.D.

8:40 a.m.

Do we have the right animal models for pre-clinical testing? Which ones are the most predictive?
Matthew J. Hardman, Ph.D.

8:55 a.m.

Panel Discussion
Jeffrey M. Davidson, Ph.D.; Song Hong, Ph.D.; Julie M. Jameson, Ph.D.; Aristidis Veves, M.D., D.Sc.

9:25 a.m.

Keynote Speech
Current successes and failures in the prevention and treatment of diabetic foot ulcers in the clinic and in clinical trials. How can we improve?
Andrew J. M. Boulton, M.D., D.Sc., FRCP

9:55 a.m.

Break

Local Interventions

Moderator: Andrew J. M. Boulton, M.D., D.Sc., FRCP

10:10 a.m.

What are the NICE recommendations for dressings? Which areas need more evidence-based research and how should this research be translated to the clinic?
William Jeffcoate, M.B., MRCP

10:25 a.m.

Is hyperbaric oxygen therapy effective compared to other therapies? What is the state of clinical research in this area?
Stephen R. Thom, M.D., Ph.D.

10:40 a.m.

What is the role of drug-releasing matrices and nanostructures in diabetic wound healing? What properties of the structures are important? What therapie would benefit from application through a drug-release matrix?
Aristidis Veves, M.D., D.Sc.

10:55 a.m.

What advantage does gene therapy offer for diabetic wound healing? What is the current state of the methodologies?
Jeffrey M. Davidson, Ph.D.

11:10 a.m.

How does the FDA handle treatments at the interface between drugs and devices? In what areas would the FDA like more evidence-based research?
Speaker From the FDA

11:25 a.m.

Panel Discussion
David M. Armstrong, D.P.M., M.D., Ph.D.; Michael Edmonds, M.D.; Robert G. Frykberg, M.P.H., D.P.M.; Benjamin A. Lipsky, M.D.; Dane K. Wukich, M.D.

11:55 a.m.

Lunch

Population Studies and Databases

Moderator: David J. Margolis, M.D., Ph.D.

12:45 p.m.

What database resources on diabetic wound healing are available? What data on patient characteristics, treatment and outcome are essential for a database?
Joseph L. Mills, Sr., M.D.

1:00 p.m.

What are the highest priority epidemiology questions for directing future clinical research, evaluating access and differences in care, and assessing cost-effectiveness?
Harold Brem, M.D.

1:15 p.m.

Can we test interventions through population studies? Can alternative study designs compensate for the lack of randomization?
David J. Margolis, M.D., Ph.D.

1:30 p.m.

Panel Discussion
Harold Brem, M.D.; William Jeffcoate, M.B., MRCP ; David J. Margolis, M.D., Ph.D.; Joseph L. Mills, Sr., M.D.

2:00 p.m.

Break

Clinical Issues

Moderator: Lawrence A. Lavery, M.P.H., D.P.M.

2:15 p.m.

Recruitment and retention strategies and inclusion/exclusion criteria.
Lawrence A. Lavery, M.P.H., D.P.M.

2:30 p.m.

Standard of care for clinical trial protocols:  off-loading, debridement, dressings, diagnosis and treatment of infections.
Robert S. Kirsner, M.D., Ph.D.

2:45 p.m.

Outcome measures and surrogate end-points: the value of complete epithelialization as a principal endpoint.
David J. Margolis, M.D., Ph.D.

3:15 p.m.

The incorporation of psychological and behavioral factors in trial design.
Loretta Vileikyte, M.D., Ph.D.

3:30 p.m.

Panel Discussion on the highest priority research questions for prevention and treatment:  weighing public health impact and cost, feasibility and scientific opportunity. Examples include:  recurrence prevention; prevention and treatment in dialysis patients; osteomyelitis treatment; hyperbaric oxygen efficacy; prevention of infections in diabetic foot ulcers; and acellular dermal matrix products
David G. Armstrong, D.P.M., M.D., Ph.D.; Christopher E. Attinger, M.D.; Paul J. Kim, D.P.M., FACAS; Benjamin A. Lipsky, M.D.; Stephen R. Thom, M.D., Ph.D.

4:15 p.m.

Summary Discussion
Moderators: Christopher E. Attinger, M.D.; Andrew J. M. Boulton, M.D., D.Sc., FRCP; Marjana Tomic-Canic, Ph.D.

5:00 p.m.

Adjournment