Non-Invasive Testing to Evaluate Wound Healing in Diabetes
A legfontosabb adatok
- Ki végzi
- University of Texas Southwestern Medical Center
- Hol
- Dallas (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Leállítva
- Résztvevők
- 157 fő vett részt
- Kezdés
- 2021. ápr. 28.
- Befejezés
- 2026. nov. 2.
- A vizsgálat típusa
- Megfigyeléses, 2 csoport
- A vizsgált kezelések
- SnapshotNIR, Kent Imaging
- A regiszteradat frissítve
- 2026. november 13.
- Miért állt le
- Study was stopped as the company that owns the hyperspectral imaging devices required their return.
Ki vehet részt
- Életkor
- 18 év – 89 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Részt vehetnek
A regiszter feltételei, szó szerint
Mind a 15 feltétel megnézéseKevesebb
Ki vehet részt
- Patient of the investigators
- Diagnosis of diabetes mellitus
- One or more moderate to severe diabetic foot ulcers/infections
- 18-89 years of age
- Over 18
- Have a foot
Ki nem vehet részt
- Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years
- Patients with a history of poor compliance; Normal Healthy volunteers
- Non-diabetic
- Is pregnant or plans to become pregnant
- Is nursing or actively lactating
- Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's ability to provide informed consent, participate in the study protocol or record study materials
- Foot wounds
- Non-English speaking
Egyéb feltételek
- Investigator patients
Helyszínek itt: Egyesült Államok
- UT Southwestern Medical Center at DallasDallas, Egyesült Államok
A vizsgálatról
Mit akar kideríteni a vizsgálat
Normal group: We will collect normative data from healthy individuals to include baseline data, screening, and images. Up to 500 people will be enrolled and can include normal healthy volunteers, staff and students/trainees. Data will be collected one time with no follow up.
A teljes eredeti leírásKevesebb
Patient group: We will prospectively collect data using one instrument (camera) (SnapshotNIR, Kent Imaging, Calgary, Alberta, Canada). We will collect non-contact imaging data before surgeries, during surgeries (if feasible), and during follow-up clinic visits. We will collect vascular data, demographic medical history, wound characteristics and measurements, frequency of debridement, off-loading, and clinic visits from existing medical records. We will collect lab data such as cultures glycosylated hemoglobin, hemoglobin and hematocrit, ESR, CRP and eGFR obtained per standard of care.
Imaging with this device is research-only.
A vizsgálat 2 csoportja
- patients with diabetic foot ulcers
* Patient of the investigators * Diagnosis of diabetes mellitus * One or more moderate to severe diabetic foot ulcers/infections * 18-89 years of age
Kezelés: SnapshotNIR, Kent Imaging
- Normal healthy volunteers
over 18 years of age have a foot
Kezelés: SnapshotNIR, Kent Imaging
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- A regiszteradat frissítve
- 2026. november 13.