Predictive and Diagnostic Biomarkers for Diabetic Foot Ulcers – c-myc and phosphorylated glucocorticoid receptor
This is a multi-center observational cohort study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict complete wound healing. Eligible and consented participants will begin standard of care treatment after collection of tissue specimens from the wound’s edge. An additional tissue specimen is collected at 4 weeks. Tissues will be tested for c-myc and phosphorylated glucocorticoid receptor (p-GR) levels using validated protocols at a central laboratory. Participants will be followed weekly for up to 12 weeks or until complete wound healing (whichever occurs first). One final assessment 2 weeks after complete wound healing will occur to confirm healing.Click here for more information on the cmyc Study.
Publications with more information regarding c-myc and pGR
- Molecular pathogenesis of chronic wounds: the role of beta-catenin and c-myc in the inhibition of epithelialization and wound healing
- Quality Assessment of tissue specimens for studies of diabetic foot ulcers
- Deregulation of epidermal stem cell niche contributes to pathogenesis of nonhealing venous ulcers
- Biology and Biomarkers for Wound Healing
- Stress Signals, Medicated by Membranous Glucocorticoid Receptor, Activate PLC/PKC/GSK - 3β/β-catenin Pathway to Inhibit Wound Closure
TRANS-EPIDERMAL WATER LOSS (TEWL) AS A PREDICTIVE MARKER FOR DIABETIC FOOT ULCER (DFU) RECURRENCE
This is a multicenter study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict DFU wound recurrence. Trans-epidermal water loss (TEWL) will be measured on the closed wound site and a location similar to the wound site (reference site). Participants will be enrolled within two weeks after closure of their DFU. Complete wound healing will be verified at a second visit two weeks later and this visit will start the 16 week timeline where participants will be followed weekly by phone until the earliest of DFU wound recurrence or 16 weeks. Participants who experience a DFU wound recurrence and a subset of participants who do not experience a DFU wound recurrence by week 16 will be asked to attend one final visit.
Click here for more information on the TEWL Study.
Adjunct collection of additional biorepository data from patients enrolled in DFC trials
This is a multicenter study of patients with diabetic foot ulcers (DFU) to develop, implement, and organize a biorepository program for the collection of biosamples and associated clinical data to inform and assist with future research endeavors. The Biorepository will guide the DFC activities for collection and storing biosamples and data from participants enrolled in current and future DFC studies. Participants will be asked to enroll at the time of DFC protocol 001 (c-myc), DFC protocol 002 (TEWL), and future DFC approved protocol enrollment. Participants will be informed of long-term archiving of biosamples in the NIDDK Central Repository (including de-identified data in the data repository) prior to enrollment in the biorepository study.
Publications with more information regarding biorepositories
Projection of the year 2050 burden of diabetes in the US adult population: dynamic modeling of incidence, mortality, and prediabetes prevalence. Population health metrics
Long term outcomes after incident diabetic foot ulcer: Multicenter large cohort prospective study (EDI-FOCUS investigators) epidemiology of diabetic foot complications study: Epidemiology of diabetic foot complications study