Non-Invasive Testing to Evaluate Wound Healing in Diabetes

Diabetic Foot Ulcer Clinical Trial

Official title:

Non-Invasive Testing to Evaluate Wound Healing in Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04232631
• Other study ID #: 2018-0386
• Status: Recruiting
• Start date: April 28, 2021
• Est. completion date: September 2025

Study information

• Verified date: July 2023
• Source: University of Texas Southwestern Medical Center
• Contact: Debby Noble
• Phone: 2146488686
• Email: Debby.Noble[@]UTSouthwestern.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Data will be collected with 3 vascular imaging devices (IntraOx Vioptix, Newark, CA; Hyperview, HyperMed Imaging, Memphis, TN; Snapshot NIH, Kent Imaging, Calgary, Alberta, Canada). The wound will be imaged with the 3 devices at index research encounter (this will count as the initial pre-operative imaging if the patient requires surgery), before surgery for interval or additional surgeries, during surgery, and during clinic follow-up (one set of imaging approximately every 3-5 weeks) visits for a maximum follow up time of 12 months or until the wound is documented as healed, whichever occurs first. The investigators will collect data from the medial and lateral angiosomes on the dorsum and plantar aspects of the foot and the anterior and posterior leg. Subject data will be obtained from the patient by oral history and physical exam and the medical records of patients of the investigators: vascular data, demographic medical history, wound characteristics and measurements, frequency of debridement and off-loading. Collection of lab data will be obtained such as cultures glycosylated hemoglobin, hemoglobin and hematocrit, ESR, CRP and eGFR obtained per standard of care. Imaging with the three devices is research-only and is not standard of care.

Description:

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

Once a patient is identified as having a 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 before, during, and on post-op day 1 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 12 months or healing of the wound, whichever comes first.

The 3 instruments do not touch the patient and are being evaluated on their ability to predict wound healing. They are research only and not standard of care, and are not being used to determine care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Patient of the investigators

• Diagnosis of diabetes mellitus

• One or more moderate to severe diabetic foot ulcers/infections

• 18-89 years of age

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer

Intervention

Device:
• IntraOx Vioptix
Vascular imaging device
• Hyperview, HyperMed Imaging
Vascular imaging device
• Snapshot NIH, Kent Imaging
Vascular imaging device

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center at Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating the effectiveness of 3 devices to measure perfusion to predict wound healing	To evaluate the effectiveness of the Hypermed, Kent and Vioptx instruments to measure perfusion to predict wound healing	Three years