N/A
N=23
Continuous Diffusion of Oxygen (CDO) Treatment for Healing of Diabetic Foot Ulcers
Foot Ulcer, Diabetic
Bottom Line
View on ClinicalTrials.gov: NCT02501538 ↗Enrolled (actual)
23
Serious AEs
4.4%
Results posted
Aug 2020
Primary outcome: Primary: Tissue Oxygenation as Measured by Hyperspectral Imaging — 63.58; 61.91; 76.33; 77.55 percent concentration of oxyhemoglobin
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcutaneous O2 device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tissue Oxygenation as Measured by Hyperspectral Imaging |
63.58; 61.91; 76.33; 77.55 | — |
| PRIMARY Tissue Perfusion as Measured by TCPO2 |
53.31; 53.64; 55.21; 59.31 | — |
| SECONDARY Change in Levels of Growth Factors and Cytokines Involved in Wound Healing |
2.68; 11.37; 18.24; 9.12; 3.97; 3.12 | — |
| SECONDARY Evaluate Changes in Bacterial Infection |
137071.35; 433719.88; 276842.20; 598557.90 | — |
| SECONDARY Percent Wound Area Reduction |
40.75; 48.64; 59.91; 7.59; -30.07; -11.21 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02501538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.