Continuous Diffusion of Oxygen (CDO) Treatment for Healing of Diabetic Foot Ulcers (EO2)
|ClinicalTrials.gov Identifier: NCT02501538|
Recruitment Status : Active, not recruiting
First Posted : July 17, 2015
Last Update Posted : January 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Foot Ulcer, Diabetic||Device: Transcutaneous O2 device||Not Applicable|
Patients seen at the University of Texas (UT) Southwestern Wound Clinic with a diabetic foot wound will be identified, consented, and screened for the study. Upon signing consent, patients will be assigned a unique screening number. The screening number given to the first patient will be 01 and increasing sequentially with each subject screened. Screened subjects will be entered onto a screening log. Once a number is assigned it cannot be re-assigned to another subject.
At Day 0, a vascular evaluation including ABI, Sensilase, Transcutaneous oxygen measurements, and hyperspectral imaging will be performed. Monofilament Sensory Test and Vibration Perception Threshold(VPT) test will also be performed at day 0.Patients will undergo standard of care wound debridement. Tissue samples will be taken routinely as standard of care. A wound assessment will be performed, including the debridement as standard of care, wound measurements, and digital photos. Gene expression and bacterial analysis will be performed on tissue samples. After tests are performed, patient will receive topical oxygen therapy using the Transcutaneous O2 device with moist wound dressings. Moist wound dressings are used as standard of care. Patient will receive instructions to continue treatment at home.
Patient will return for an appointment at days 7, 14, and 21, where vascular assessment (Sensilase, Transcutaneous oxygen measurements, Hyperspectral imaging) ,wound assessment (wound measurements, digital photos and acetate tracings) and tissue sampling will be performed following standard of care debridement, Patient will cease topical oxygen treatment at day 21, and study will be concluded.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Continuous Diffusion of Oxygen (CDO) Treatment for Healing of Diabetic Foot Ulcers|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||January 10, 2019|
|Estimated Study Completion Date :||May 2020|
Experimental: Transcutaneous O2 device
Continuous diffusion of oxygen (CDO) (topical oxygen) therapy, which will be administered using a portable device.
Device: Transcutaneous O2 device
A portable device that delivers continuous diffusion of oxygen.
- Cutaneous circulation and tissue perfusion as measure by hyperspectral imaging [ Time Frame: 21 days ]Hyper spectral imaging (Hyper Med)
- Cutaneous circulation and tissue perfusion as measure by Sensilase [ Time Frame: 21 days ]Skin Perfusion Pressure measurements (Sensilase, Vasa med)
- Cutaneous circulation and tissue perfusion as measure by TCPO2 [ Time Frame: 21 days ]Transcutaneous oxygen pressure (TCPO2)
- Levels of growth factors and cytokines involved in the wound healing [ Time Frame: 21 days ]Comparison of measurements inflammatory cytokines: Interleukin 6 (IL-6), Interleukin 8 (IL-8), tumor necrosis factor (TNF)-α and growth factors: vascular endothelial growth factor (VEGF), platelet derived growth factor (PDGF), insulin derived growth factor (IGF), transforming growth factor beta (TGF)-β Evaluated from tissue samples obtained at Baseline and Days 7, 14 and 21.
- Changes in gene expression over treatment period [ Time Frame: 21 days ]Comparison of gene expression by analysis of tissue samples obtained at Baseline and Days 7, 14 and 21.
- Evaluate changes in bacterial infection before, during and after treatment [ Time Frame: 21 days ]
- Comparison of quantitative measurements in bacteria
- Comparison of qualitative analysis in bacteria
- Comparison of appearance or reappearance of infection over treatment period in wounds treated with CDO and wounds treated with standard of care
- Rates of wound healing [ Time Frame: 21 days ]Wound healing (granulation, wound size measurements) at Baseline and Days 7, 14 and 21.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501538
|United States, Texas|
|UT Southwestern Medical Center at Dallas|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Lawrence A Lavery, DPM||UT Southwestern Medical Center|