Non-Invasive Testing to Evaluate Wound Healing in Diabetes

Обзор

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. 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.

Подробное описание

This is a prospective, observational study. All medical and surgical care provided to the patient group will be standard of care.

Patient group: Once a patient is identified as requiring vascular intervention or lower extremity ulceration (includes lower extremity wound of any cause, a surgical incision, a flap or graft) and consent to participation, their lower extremity will be imaged. They will be imaged preop, intraop (if feasible) and on post-op day 1 + or - 7 days if they require surgery and for each surgery related to the ulceration. They will also be imaged once a month in follow up for up to a total of 6 months or healing of the wound, determined by study physician.

Normal group: The normal group will have one-time imaging and data collection.

The Kent instrument does not touch the patient and is being evaluated to measure perfusion to predict wound healing, flap survival and amputation level healing. They are research only and not standard of care, and are not being used to determine care in the patient group.

Вмешательства

• Устройство SnapshotNIR, Kent Imaging
  Vascular imaging device

Первичные конечные точки

• Evaluating the effectiveness of SnapshotNIR device to measure perfusion to predict wound healing, flap survival and amputation level healing. The device will report the oxygen saturation, oxyhemoglobin and deoxyhemoglobin levels in superficial tissue. [Срок оценки: Three years]

Критерии участия

Investigator patients

Критерии включения

• Patient of the investigators
• Diagnosis of diabetes mellitus
• One or more moderate to severe diabetic foot ulcers/infections
• 18-89 years of age

Критерии исключения

• Non-diabetic
• Is pregnant or plans to become pregnant
• Is nursing or actively lactating
• 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.
• 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
• Patients with a history of poor compliance

Normal Healthy volunteers

Критерии включения

• Over 18
• Have a foot

Критерии исключения

• Foot wounds
• Non-English speaking

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 1 центр

• UT Southwestern Medical Center at Dallas — Dallas

Идентификаторы

NCT: NCT04232631 · 2018-0386

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗