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Continuous Diffusion of Oxygen (CDO) Treatment for Healing of Diabetic Foot Ulcers (EO2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02501538
Recruitment Status : Active, not recruiting
First Posted : July 17, 2015
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:
This is a pilot study. Maximum 30 subjects with a diabetic foot ulcer (DFU) or surgical foot wound will be consented in order to have 20 eligible subjects who will be enrolled and completed the study. Study duration will be three weeks. Patients will be consented and undergo debridement as standard of care at day 0. Ankle-Brachial Index (ABI), Monofilament Sensory Test and Vibration Perception Threshold(VPT) test will be performed only at day 0. Tissue samples will be taken at this visit during standard of care wound debridement and these tissue samples of the wound would normally be removed as part of routine debridement. These tissue samples of the wound will be used for gene expression and bacterial analysis(research). The patient will then receive topical oxygen therapy using the Transcutaneous O2 device (research) with moist wound dressings for 21 days. Moist wound dressings are used as standard of care. Treatment will be initiated during Screening/Baseline visit(day 0) after routine wound debridement, and patient will receive instructions for home use of the device. The patient will be seen for routine wound debridement at days 7, 14, and 21 with a study window of 5 days., Digital photos of the wound, and vascular evaluations (Transcutaneous oxygen measurements and Hyperspectral imaging. will be performed at each study visit(research). Tissue samples will be taken during standard of care wound debridement at every study visit. Results of the data analysis from this project will be used to inform the design of a larger randomized clinical trial.

Condition or disease Intervention/treatment Phase
Foot Ulcer, Diabetic Device: Transcutaneous O2 device Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Cutaneous circulation and tissue perfusion as measure by hyperspectral imaging [ Time Frame: 21 days ]
    Hyper spectral imaging (Hyper Med)

  2. Cutaneous circulation and tissue perfusion as measure by Sensilase [ Time Frame: 21 days ]
    Skin Perfusion Pressure measurements (Sensilase, Vasa med)

  3. Cutaneous circulation and tissue perfusion as measure by TCPO2 [ Time Frame: 21 days ]
    Transcutaneous oxygen pressure (TCPO2)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. Rates of wound healing [ Time Frame: 21 days ]
    Wound healing (granulation, wound size measurements) at Baseline and Days 7, 14 and 21.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects of all races and ethnicities, age 18-89
  • Diagnosis of diabetes mellitus
  • Has a diabetic foot ulcer

Exclusion Criteria:

  • End-stage renal disease (ESRD)
  • Has untreated foot ulcer at time of study
  • HIV, hepatitis, autoimmune disease, Systemic lupus erythematous (SLE), Raynaud's disease
  • Ankle-Brachial Index (ABI) < 0.4
  • Unable or unwilling to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501538


Locations
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United States, Texas
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Lawrence A Lavery, DPM UT Southwestern Medical Center
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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02501538    
Other Study ID Numbers: 012015-051
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases