Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K23DK131261 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
This research is being done because people with diabetes have reduced healing capacity and prone to develop infections of foot wounds. This can be problematic because wounds that become infected may result in amputation and more severe complications. New evidence suggests that a better understanding of the microbiome of wounds (e.g., bacterial presence) may provide information about wound healing and provide an earlier opportunity to identify an individual who may be prone to develop diabetic foot infection in their wound.
Therefore, the purpose of this study is to evaluate the role of the microbiome of the diabetic foot ulcer in development of infection and wound healing. Once the role of the microbiome is confirmed, progress towards the prevention and treatment of diabetic foot ulcers and complications may be possible.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infected DFU cohort | 25 participants that have an infected DFU will be enrolled. |
| |
| Non-infected DFU cohort | 75 non-infected participants with DFU will be enrolled. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wound debridement | Procedure | Participant that are having usual care visits for management of diabetic foot ulcers will be enrolled into this study. The procedure is done as part of standard of care. Tissue from the samples will be analyzed for this study. Aliquoting and Deoxyribonucleic acid (DNA) extraction will be done on the specimens. Bacterial DNA from biospecimens will be isolated, quantified, amplified, and sequenced. |
| Measure | Description | Time Frame |
|---|---|---|
| The percent change in foot ulcer surface area (cm2) after 12 weeks of observation for either infected or non-infected diabetic foot ulcers | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The percent of clinically resolved infected DFU for infected diabetic foot ulcer participants | Defined as improvement of greater or equal to 2 clinical signs (Local swelling or induration, erythema, local tenderness or pain, local warmth, purulent discharge) with no requirement for additional antibiotic(s). | Baseline to 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Subjects that are seen during usual care visits for management of diabetic foot ulcers in the University of Michigan (UM) Podiatry clinics within Metabolism, Endocrinology and Diabetes (MEND), the UM Comprehensive Wound Care Center, and from those consented participants in the Diabetic Foot Consortium (DFC) Biomarkers for Active Diabetic Foot Ulcers study,
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian Schmidt, DPM | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016523 | Foot Ulcer |
| D003920 | Diabetes Mellitus |
| D014947 | Wounds and Injuries |
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007871 | Leg Ulcer |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Total days of antibiotic therapy for the DFU infected diabetic foot ulcer participants |
| Baseline to 12 weeks |
| Number of days to infection resolution for the DFU infected diabetic foot ulcer participants | Baseline to 12 weeks |
| The percentage of participants with an infected DFU at baseline that resolve clinical infection by study week 4 | Baseline to 4 weeks |
| Post-study percentage change of wound surface area (cm2) for both cohorts | Baseline to 12 weeks |
| Proportion of participants that reach a 50% reduction in surface area of the DFU for both cohorts | Baseline to 4 weeks |
| D012883 |
| Skin Ulcer |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007239 | Infections |